PRINCIPLES AND PRACTICE

OF CLINICAL RESEARCH

WELCOME PACKET

Global Collaborative Program in Clinical Research

Program Director
Felipe Fregni, MD, PhD, MMsc, MPH, MEd
 TABLE OF CONTENTS 24 SYLLABUS
Grading And Pass-Fail Criteria
2 TABLE OF CONTENTS
25 GRADING BREAKDOWN
Grading Breakdown
4 WELCOME LETTER Bonus Points
Grading Criteria For The Group Project
5 GENERAL INFORMATION
Who Participates in the Program
Grading Criteria For The Homework Assignments
Grading Criteria For Faculty And Staff Grade
Investment In The Future Grading Criteria For Lecture Participation
Program Content Grading Criteria For Formulating A Question
Format Grading Criteria For Pre-Program And Post-Program Assignment
Learning Tools Grading Criteria For Bonus Assignment For An Article Review Assignment
Expectations For Participants Grading Criteria For Project Bonus Points
Required Textbooks
Optional Books
Statistical Software
28 FORUM

31 ASSIGNMENT
8 INTERNATIONAL SITES & CONTACT INFORMATION
32 EXAMS
11 FACULTY MEMBERS
34 WEBSITE

13 PROGRAM ORGANIZATION & OBJECTIVES

Program Organization 35 LECTURES
Live lectures
Program Objectives Web-based remote access connection
Module 1 – Basics Of Clinical Research Seat assignment in sites
Module 2 – Basic Statistics Responsible use of computers during class
Module 3 – Statistics & Trial Design Attendance
Module 4 – Practical Aspects Of Clinical Research Frequently asked questions
Module 5 – Study Design Friday morning lectures
Module 6 – Group Project
Module 7 – 5-Day Immersion Course Module
Module 8 (Optional Add-On) – 3-Day Advanced Statistical Workshop
Module 9 (Optional Add-On) – Manuscript Writing Workshop 38 ADDITIONAL PROGRAM SUPPORT
Site director (sd)
Teaching assistants (ta)
Site monitors (sm)
15 MAIN PROGRAM
Module 1 – Basics Of Clinical Research
Websites – online platforms
Module 2 – Basic Statistics
Module 3 – Statistics & Trial Designs
Module 4 – Practical Aspects Of Clinical Research
40 ACADEMIC CALENDAR

Module 5 – Study Designs

Module 6 (During the July Break) – Group Project 42 ACADEMIC RULES, RIGHTS, AND RESPONSIBILITIES
General standards of conduct
Optional 3-Day Advanced Statistical Workshop, Boston
Honor code
Optional 2-Day Research Manuscript Writing Workshop, Boston
Plagiarism
5-Day Immersion Course
Copying and pasting in the forum and plagiarism

23 WEEKLY TASKS
Weekly Routine 44 PRE-PROGRAM ASSIGNMENT
Case Study
Reading Material
Office Hours/Group Discussion 45 LECTURE READINGS

2 3
WELCOME LETTER GENERAL INFORMATION
Congratulations! Who Participates in the Program
Applicants usually have a graduate degree or a health care professional degree (MD, MPH,
We are pleased to inform you that you have been accepted into the 2024 Principles and Practice of biostatistics, epidemiology, nursing, physical and speech therapy, pharmacy, and dentistry) and come
Clinical Research (PPCR) program. from several countries, given that participants can partake in the course remotely in their own city.
Although participants can take this program locally, interaction with other students and instructors as
You are about to begin an intensive and demanding clinical research-training program offered by well as participation in the program activities is a requirement for the successful completion of the
Harvard T.H. Chan School of Public Health Executive and Continuing Professional Education (ECPE). program.
We have no doubt that by the end of this program your effort will have been worthwhile.
Investment in the Future
You will be joining a group of participants who bring not only impressive academic training, but also By helping researchers improve their skills in clinical research in a highly interactive environment, this
professional experience. You are commended on the fine record of achievement by which you earned program will promote personal and professional growth and help participants become more effective
your place in the 2024 class. in their work. We also expect that the interactive environment of the program will promote connections
between participants and help foster future collaborative, multicenter projects. Our goal is to offer a
Principles and Practice of Clinical Research has been carefully designed to create a very interactive highly interactive learning environment for international clinical research training while creating a
platform to enhance learning through a highly collaborative method. You are joining PPCR in its 16th global network of clinical researchers to foster future collaboration in clinical research.
iteration, and we are confident that the improvements we have been making to the program since its
first iteration in 2008 will result in a better learning experience for you.
Program Content
The Principles and Practice of Clinical Research faculty, staff, and alumni join us in welcoming you, and Our program covers topics from the basics of clinical research (such as how to formulate a research
we look forward to seeing you in our weekly discussions on Thursday evenings. We are confident that question, how to select a study population, and randomization and blinding methods) to statistical
your experience in our Harvard T.H. Chan School program will be an enjoyable and challenging part of methods (data distribution and classification, statistical tests, sample size calculation, survival analysis,
your professional and personal development. We wish you great success over the next nine months. missing data, and meta-analysis); data collection, monitoring, and reporting (including training in
manuscript writing); and study designs (observational studies, non-inferiority and adaptive designs, and
We hope that this program will also provide linkages that will continue after its conclusion, whether it randomized clinical trials).
be working together on a writing project, collaborating on research activities, sustaining a friendship
that started during the program, visiting each other in other countries, or other connections. Format
This program is a distance-learning program; weekly 3-hour interactive videoconference lectures are
Welcome to the beginning of this experience! broadcast from Harvard T.H Chan to different sites around the world. Participants are required to
attend the videoconference lectures at a host site with participants from the same location
(for instance, participants from Dresden, Germany meet at the University of Dresden site for the live
connection with Harvard). Although joining a site is the preferred method, those who are unable to do
so can participate via Web-based remote access. Participants are required to participate in forum
discussions, read articles, and complete weekly exercises on statistics and clinical research in
general. At the end of the program, there will be a live 5-Day Immersion Course to practice the
Felipe Fregni, MD, PhD, MMSc, MPH, MEd concepts learned in the program. The optional 3-Day Advanced Statistical Workshop and Research
Professor, Harvard T.H. Chan School of Public Health Manuscript Writing Workshop will be conducted in Boston, Massachusetts.
Professor, Harvard Medical School
PPCR Founder and Director

4 5
 Expectations for Participants
• Participation in class and on the website, which includes both speaking (or posting comments)
and listening.
• Effort to make this class your own. Remember that our method of collaborative learning depends
also on your participation.
• Completion of all program assignments, including program readings.
• Collaboration with other participants; as a part of the program, you should help your colleagues
if you know the answer. This will help not only your colleagues, but will allow you to see different
opinions and ideas from a multicultural point of view.
• Courage to challenge what you read or hear. Courage to post your comments on the website.
Remember, there are no silly comments or questions.
• Be cognizant that during video conference lectures, your participation and engagement will affect
Learning Tools everyone’s performance.
The following learning tools are used in the program:
• Live Connection with Harvard T.H. Chan (videoconference lectures): Our program consists of 27 Required Textbooks
lectures taught by faculty from Harvard T.H. Chan School of Public Health, Harvard Medical School, • Critical Thinking in Clinical Research by Felipe Fregni and Ben Illigens. Oxford University Press
and Tufts Medical Center. Each weekly lecture includes a 60-minute interactive module led by the 2018. The book can be ordered online here: https://a.co/d/5PmtAsp, and the e-book version can
program director to discuss the online poll and case study written specifically for the program; a also be ordered for immediate online delivery in web stores such as Amazon or Google play.
60-minute teaching/lecture module; 60-minute live question/answer discussion module in which • The Questions and Answers Book on Statistics for Clinical Researchers by Felipe Fregni. The book
participants interact directly with faculty. is available on Amazon here: https://a.co/d/a6rXo9KWe recommend ordering as soon as possible if
• Discussion Forum: Each weekly lecture/topic includes a required online discussion forum. you want the print version as, depending on yourlocation, it may take six or more weeks to arrive.
• Online Polls: Participants take weekly polls addressing the topic of the subsequent lecture. • The PPCR Guide for STATA: A practical guide for clinicians to analyze clinical research data inSTATA
• Assignments: Participants are required to submit practical assignments related to weekly lectures, by Felipe Fregni. The book can be ordered here: https://a.co/d/7Arr7YG
including statistics assignments, as part of the statistical training component of the program.
Participants usually have one week to complete the assignment—the submission period closes at
4:00pm ET (Boston time) every Thursday. Assignments are accepted for credit only when Optional Books
successfully submitted through the program website and within the deadline. • Foundations of Clinical Research: Applications to Practice (3rd Edition) (Foundations Of Clinical
• Asking Questions: Participants have intensive interaction with faculty and staff via office hours chats Research) by Leslie Gross Portney, Mary P. Watkins. Pearson Prentice Hall.
and during the live lectures. • Clinical Trials in Neurology by Felipe Fregni. Humana Press/Springer Protocols (1st edition).
• Group Project and Mini Review: Participants are required to participate in a group project in which • A Gentle Introduction to Stata by Alan C. Acock. Stata Press.
they work together to write a grant application. The project is created using an online interactive tool
to enhance team communication and task management, the Ryver Chat platform (same used for the Statistical Software
forum of discussion). The final version of the project should be uploaded in a specific section of the All participants will be provided with a 6-month Stata 18 BE (GradPlans™) license to be used only for
website by the deadline. Most participants choose to submit their final project (reviewed by faculty program-related work during the course of the program.
members) to our online peer-reviewed international journal for publication (www.ppcr.org/journal) or
they can choose to submit to another academic journal (again, submission is not required). The final
group project should have the format of a scientific paper describing a project.
• Use of Social Media to Increase Post-Program Interaction (Long-term Vision for Participants):
Participants are strongly encouraged to continue their interaction through our Alumni community,
which was created to maintain interaction between participants for the discussion of
clinical research topics.
o Facebook: https://www.facebook.com/groups/ppcralumni/
o Instagram: https://www.instagram.com/ppcr_course/
o Twitter: https://twitter.com/PPCR_Course
o LinkedIn: https://www.linkedin.com/in/ppcr-program

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 Ribeirão Preto, São Paulo Brazil - Hapvida São Paulo, Brazil - Hospital Sírio Libanês
INTERNATIONAL SITES & SITE CONTACTS (Hospital São Francisco) Tiago Lazzaretti, MD
Kenneth Almeida Email: tiagot86@hotmail.com
Email: kenneth.almeida@hapvida.com.br
São Paulo, Brazil - Instituto D’Or de Pesquisa e Ensino
Rio de Janeiro, Brazil - Instituto de Educação Médica Camila Motta Venchiarutti Moniz, MD, PhD
IDOMED Email: camila_med33@yahoo.com.br
João Antonio Pereira Correia
Email: joao.correia@yduqs.com.br São Paulo, Brazil - IBCC Oncologia
Felipe Melo Cruz, MD, PhD
Ribeirao Preto, São Paulo, Brazil - Hapvida Email: felipemcruz@yahoo.com.br
(Hospital Sao Francisco)
Kenneth Almeida São Paulo, Brazil - Universidade de São Paulo (USP)
Email: kenneth.almeida@hapvida.com.br Linamara Rizzo Battistella
Email: linamara.battistella@hc.fm.usp.br
Rio de Janeiro, Brazil -
Instituto D’Or de Pesquisa e Ensino Chile
Daniella Parente Santiago, Chile - Abbott
Email: daniella.parente@gmail.com
Santiago, Chile - Clinica Alemana
Salvador, Brazil - Centro Medico Mater Dei Salvador Daniela Masoli, MD
Juleilda Nunes, MD Email: daniela.masoli@gmail.com
Email: juleilda.nunes@ppcr.org
João Paulo Velloso Medrado Santos Santiago, Chile - Clinica Davila
Email: jpaulo.medrado@ppcr.org Jose Retamal
Email: jose.retamal@davila.cl
United States Curitiba, Brazil Salvador, Brazil - Hospital São Rafael, IDOR
Boston, MA - Harvard T.H. Chan School of Public Health Miguel Morita Fernandes da Silva Livia Andrade Santiago Chile - Hospital del Trabajador
Felipe Fregni, MD, PhD, MMSc, MPH, MEd Email: mim247@mail.harvard.edu Email: lmsandrade@yahoo.com.br Pablo Carreno Montenegro PT, MsC
Email: felipe.fregni@ppcr.org Email: picarrenom@achs.cl
Curitiba, Brazil - Hospital Santa Cruz - Rede D’Or São Paulo, Brazil - A.C. Camargo Cancer Center
Argentina Raphael Alves Felipe Coimbra, MD China
Buenos Aires, Argentina - Centro Oftalmologico Charles Email: rgalves@gmail.com Email: drfelipecoimbra@gmail.com Guangzhao, China
Patricio Schlottmann Dian Zeng, MD
Email: schlottp@yahoo.com.ar Fortaleza, Brazil - Hapvida (Hospital Antonio Prudente) São Paulo, Brazil - Beneficência Portuguesa de São Paulo Email: dianzeng@neuromodulationlab.org
Kenneth Almeida Ana Beatriz and Marcos Magalhaes
Neuquen, Patagonia, Argentina - CMIC Salud Email: kenneth.almeida@hapvida.com.br Emails: ana.akel@bp.org.br, marcos.magalhaes@bp.org.br Colombia
Juan Manuel Linares Bogota, Colombia - Abbott EPD
Email: juanmanuel.linares.86@gmail.com Goias, Brazil - Hapvida (Hospital America) São Paulo, Brazil - Butantan Institute Karen Hurtado Colorado, MD
Kenneth Almeida Dr. Esper Georges Kallás Email: karen.hurtado@ppcr.org
Brazil Email: kenneth.almeida@hapvida.com.br Email: marcelo.santoro@butantan.gov.br
Belem, Para, Brazil (Hospital RioMar - Hapvida) Cali, Colombia - ICESI
Daniela Laranja, MD Londrina, Brazil - PUCPR São Paulo, Brazil - FM ABC Jaime Alberto Restrepo Tovar
Email: daniela.laranja@hapvida.com.br Alcindo Cerci Neto Marcelo Rodrigues Bacci, MD, PhD Email: jarestrepo@icesi.edu.co
Email: alcindo.cerci@gmail.com Email: mcbacci@yahoo.com
Belo Horizonte, Brazil - Virtu Oftalmogoia Costa Rica
Joao Neves de Medeiros Manaus, Amazon, Brazil - São Paulo, Brazil - HCor Research Institute (IP-HCor) San Jose, Costa Rica - UCIMED
Email: joaonevesdemedeiros@yahoo.com.br Federal University of Amazon Alexandre Biasi Fanny Chan
Robson Amorim Email: abiasi@hcor.com.br Email: chansf@ucimed.com
Brasilia, Brazil - IDOR Email: amorim.robson@gmail.com Sebastian Ospina
Lucila Soares da Silva Rocha São Paulo, Brazil - Hospital Oswaldo Cruz Email: ospinahs@icimed.cr
Email: lucilassr@gmail.com Passo Fundo, RS, Brazil - Clinica Kozma Daniela Laranja, Icaro Boszczowski MD
Stephan Pinheiro Emails: icaro.boszczowski@haoc.com.br, daniela.ro- Dominican Republic
Campinas, Brazil - Faculdade São Leopoldo Mandic Email: pinheiro94ms@gmail.com drigues@haoc.com.br Santiago, Dominican Republic
Tais Hortensio Maria Zunilda Nunez
Email: tais.hortencio@slmandic.edu.br Porto Alegre, Brazil - São Paulo, Brazil (Hospital Santa Catarina Paulista) Email: nunez.zunilda@gmail.com
Universidade Federal do Rio Grande do Sul (UFRGS) Andre Mateus, MD
Campinas, Brazil - UNICAMP Wolnei Caumo, MD andre.mateus@ppcr.org Santo Domingo, DR - CEDIMAT
Carolina Lins, MD Email: wcaumo@hcpa.edu.br Julia Rodriguez, MD MSc
Email: ppcrunicamp@gmail.com Email: jjrodriguez@cedimat.net
8 9
 SAESP, Brazil
Santo Domingo, DR - Two Oceans in Health Paraguay Maria Jose Carmona
Marija Miric, MA, PhD Asunción, Paraguay - Universidad del Pacífico
Email: mmiric@twooceans.health Email: maria.carmona@fm.usp.br
Daniela Garlisi, MD Vanessa Carvalho
Email: danielagarlisi01@gmail.com Email: vanessahcarvalho74@gmail.com
Ecuador Raul Aveiro, MD
Cuenca, Ecuador - Universidad de Cuenca Julia Araujo
Email: raul.aveiro45@gmail.com Email: rii@saesp.org.br
Dunia Abad
Email: dunia.abadc@ucuenca.edu.ec Peru Professor Areerat Suputtitada, MD Group Thailand
Lima, Peru - UPeU Areerat Suputtitada,MD
Guayaquil, Ecuador - Clinica Borja Luis Rivera
Francisco Borja Email: prof.areerat@gmail.com
Email: luis.rivera-2023@ppcr.org,
Email: francisco.borja-2019@ppcr.org rectorado@upeu.edu.pe Program Contacts
Quito, Ecuador - Abbott Program Director
Lima, Peru - USMP Felipe Fregni, MD, PhD, MMSc, MPH, MEd
Cristina Chavez Tamara Jorquiera, MD, Msc
Email: cristinaantonieta.chavez@abbott.com Phone: 617-952-6156
Email: tjorquiera@usmp.edu.pe Email: felipe.fregni@ppcr.org
Germany Portugal Program Coordinators
Chemnitz, Germany Porto, Portugal - Universidade Portucalense (UPT)
Prof. Dr. med. habil. Lutz Mirow Henrique Coelho
Jorge Leite Megan VerPlank
Email: l.mirow@skc.de Email: jorgel@mail.upt.pt Elly Pichardo
Nathalie Paez-Ring
Dresden, Germany Qatar Phone: 617-952-6154
Timo Siepmann, MD Doha, Qatar
Email: timo.siepmann@uniklinikum-dresden.de Email: 2024coordinator@ppcr.org
Mohamed Hashim, MD
Email: mohamed.hashim@ppcr.org Associate Director of Education
Munich, Germany Alma T Sanchez Jimenez, MD
Danielle Wendling Saudi Arabia Email: alma.sanchez@ppcr.org
Email: Danielle.Wendling@med.uni-muenchen.de Mecca, Saudi Arabia - Al Qura University
Abdul Haseeb Website and Technology Engineer
Guatemala Email: abdul.haseeb@ppcr.org Mauricio Matsubara
Guatemala City, Guatemala - Francisco Marroquin Email: mmatsubara@sciere.com.br
University Spain
Jose Francisco Molares Madrid, Spain - Merz Pharma
Email: ppmorales@ufm.edu Carlos Cordero Garcia, MD
Email: carlos.cordero@ppcr.org
Honduras
Tegucigalpa, Honduras Switzerland
Manuel Sierra, Alejandro Young, Marcela Banegas Basel, Switzerland
Emails: alejandro.young@unitec.edu.hn, Melissa Lee Fen Amrein
manuel.sier-ra@unitec.edu.hn, Email: melissaleefen.amrein@usb.ch
marcebane@gmail.com
Groups
Japan EBaSMMAI Group, Italy
Tokyo, Japan Salvatore Minella
Keiko Ueda, MD Email: salvatore.minnella@ppcr.org
Email: keiko.ueda@ppcr.org
SOSORT Group, Italy
Mexico Fabio Zaina
Mexico City, Mexico - INN Email: fabio.zaina@isico.it
Daniel San Juan, MD
Email: pegaso31@yahoo.com EUROFARMA Group, Brazil
Alejandro Rodriguez Camacho, MD Daniele Hamamoto
Email: arc.oncoradio@gmail.com dani_rp08@hotmail.com,
daniele.hamamoto@eurofarma.com
Mexico City, Mexico - Tec de Monterrey, CCM
Blanca Bazan Perkins
Email: blancaperkins@gmail.com

10 11
 Donald Halstead
FACULTY MEMBERS Director of Writing Programs, Harvard T.H. Chan School of Public Health
Felipe Fregni, MD, PhD, MMSc, MPH, MEd
Heather Baer, ScD
Professor of Epidemiology, Harvard T.H. Chan School of Public Health
Associate Epidemiologist, Brigham and Women’s Hospital
Professor of Neurology, Harvard Medical School
Assistant Professor of Medicine, Harvard Medical School
Professor of PM&R, Harvard Medical School
Instructor in Epidemiology, Harvard T.H. Chan School of Public Health
Director, Laboratory of Neuromodulation, Spaulding Rehabilitation Hospital and M.A. General Hospital
Ingeborg Friehs, MD
Albert Hofman, MD, PhD
Instructor in Surgery, Cardiac Surgery, Children’s Hospital Boston
Stephen B. Kay Family Professor of Public Health and Clinical Epidemiology
Chair of the Department of Epidemiology Armando Teixeira-Pinto, PhD, AM
Epidemiology Associate Professor, University of Sydney
Harvard T.H. Chan School of Public Health
Amanda Marie Midboe
Howard Sesso, PhD
Associate Adjunct Professor, Med: Public Health Sciences, Stanford University School of Medicine.
Associate Professor of Epidemiology, Harvard T.H. Chan School of Public Health
Michele Hacker, PhD Gonzalo Patricio Labarca Trucios, M.D.
Associate Professor of Epidemiology, Harvard T.H. Chan School of Public Health Instructor in Medicine, Brigham and Women’s Hospital
Vice Chair of Epidemiological Research, Beth Israel Deaconess Medical Center Harvard Medical School
David Wypij, PhD Tentative. Please see the website for final faculty list.
Senior Lecturer, Biostatistics, Harvard T.H. Chan School of Public Health
Associate Professor of Pediatrics, Harvard Medical School
Director of the Statistics and Data Coordinating Center,
Department of Cardiology, Children’s Hospital Boston
Mark Barnes, JD, LLM
Partner, Ropes & Gray LLP
Former Senior Associate Provost for Research and Chief University Research
Compliance Officer at Harvard University
Joseph Massaro, PhD
Associate Professor, Boston University School of Public Health Director of Statistical Consulting,
Harvard Clinical Research Institute
Roger Davis, ScD
Associate Professor of Biostatistics, Harvard T.H. Chan School of Public Health

Kathy Brenner
English Tutor, Department of Nutrition, Harvard T.H. Chan School of Public Health

John Orav, PhD

Associate Professor of Biostatistics, Harvard T.H. Chan School of Public Health and
Harvard Medical School
Jessica Paulus, ScD
Assistant Professor, Tufts University, School of Medicine
Associate Director, Design and Data Resource Center, Tufts Clinical Translational Science Institute
Farzad Noubary, PhD
Assistant Professor, Tufts Medical Center; Senior Statistician

12 13
PROGRAM ORGANIZATION AND OBJECTIVES Module 3 – Group Project (Designing a Grant Proposal), and July Workshops
Participants will be required to work on the group project that will be extensively reviewed and
Program Organization discussed at the 5-Day Immersion Course. Most of the group project work will take place between
This program comprises nine months of main modules, including a group project and a live 5-Day Modules 1 and 3, and in Module 3 there will be a 6-week period without recurrent Thursday lectures
Immersion Course, plus an optional live three-Day Advanced Statistical Workshop and live Research that will be dedicated to the Group Project development.
Manuscript Writing Workshop.
Participants are required to attend a weekly three-hour interactive videoconference lecture with Module 4 – Basic Statistical Analysis for RCTs and Observational Studies
participants from the same location (for instance, participants from Dresden, Germany, meet at University Module 4 will introduce the basic statistical methods used in clinical trials. We will also discuss how to
of Dresden for the live connection with Harvard T.H. Chan). select and apply appropriate statistical methods to analyze data from clinical trials and how to present,
interpret, and discuss the analyses clearly and concisely. Other topic included is regression modeling.
Videoconference lectures are broadcast from Harvard to different site centers across the world. Every
lecture will take place from 4:00pm-7:00pm ET (Boston time). Participants are also required to read Milestone 2 - Paper 2 “Data Analysis Project of a Public Available Dataset” - By the end of Module
articles and case studies, complete weekly statistical and clinical research assignments, participate in 4 the data analysis project final draft should be completed and submitted for publication.
discussion forums, and vote in a weekly poll.
Participants are also required to contribute to a group project, co-authoring a draft of a clinical study Module 5 – Other Study Designs and Analysis Tools for Grant Proposals
proposal. At the end of the nine-month long main modules, there is the intensive 5-Day Immersion Module 5 will explore basic statistics, including the difference between covariate adjustment and
Course in which participants practice the concepts learned in the main component (location of the subgroup analysis and explore other types of clinical trials. Topics covered include introduction to
course to be announced). meta-analysis, non-inferiority designs, sample size calculation and survival analysis.
The main modules are divided into six mandatory modules, two optional workshops, and one optional Milestone 3 - Paper 3 “Grant Proposal” - By the end of Module 5 the grant proposal final draft should
but strongly recommended 5-Day Immersion Course. be completed and submitted for publication.

Program Objectives
This program aims to provide participants with an understanding of the issues involved in the design,
Module 6 – Clinical Research Project Execution and Dissemination
Module 6 will discuss the main features of clinical trials, including methodological and organizational
conduction, analysis, and interpretation of randomized controlled trials of health interventions.
considerations. We will discuss participant adherence and recruitment, safety, clinical and surrogates
Students will be trained to develop skills to scrutinize information, critically analyze and carry out
outcomes, multicenter trials, and manuscript writing. Other topics included are Presentation and
research, and communicate effectively.
Graphs and Funding and IRB.

PROGRAM MODULES Module 7 – 5-Day Immersion Course

Module 1 – Introduction to Clinical Research, Systematic Review and Critical Appraisal In the 5-Day Immersion Course, Harvard faculty will review and discuss material presented throughout
the modules in a detailed and intensive fashion. The 5-Day Immersion Course is an important
and Design of Experimental Studies/RCTs component and is intended to give participants hands-on experience in clinical trial design and
Module 1 will provide participants with a solid understanding of the basic issues in clinical trial design.
analysis. In one important component of the 5-Day Immersion Course, participants will review their
This module includes the fundamental principles of clinical trials, such as study population, selection of
group projects with Harvard faculty and other experts in the field. The 5-Day Immersion Course is the
the research question, research ethics, basic study design, randomization, and blinding.
final activity of the program, and it is included in the main program fee, there is no extra payment to
attend. The location is to be defined. Sadly, it is not possible to attend online.
Module 2 – Observational Studies: Design, Critical Appraisal and Introduction to
Publicly Available Datasets and Real World Data Module 8 (Optional Add-On) – 3-Day Advanced Statistical Workshop
Module 2 will introduce the main study designs used in clinical trials, focusing on observational studies. This workshop provides additional statistical training for PPCR participants who want to acquire more
The advantages and drawbacks of each design will be presented, including the analytical methods. advanced methods especially in how to design and analyze studies using multiple variables
(multivariate analysis. Participants will not only review and expand their statistical knowledge but will
Milestone 1 - Paper 1 “Systematic Review” - By the end of Module 2 the mini reviewed final draft
be able to apply their skills to their own research. During the workshop, participants will learn how to
should be completed and submitted for publication.
work with data sets, fit a model, conduct statistical tests in STATA, and read and interpret the STATA
output. After the workshop, participants will be familiar with the challenges, limitations, and issues of
analyzing data and interpreting the results, which will help them to better read the scientific literature,
review manuscripts, and write their own manuscripts and grants. The dates are July 29-31, 2024, and it
14 15
will take place in Boston, MA.
MAIN PROGRAM
Module 9 (Optional Add-On) – Research Manuscript Writing Workshop All times are in ET (Boston time). Speaker list is tentative. Changes to the speaker list, including the
This intensive workshop introduces participants to essential concepts and tools for writing and order of lectures, may happen before start of the program.
preparing manuscripts. Focusing on the PPCR manuscript writing, participants in this
collaborative-learning workshop will gain significant new insight into the logical structures and Module 1 – Introduction to Clinical Research/Systemic Review and Critical Appraisal
narrative pathways of persuasive arguments that are essential to effective manuscript writing. We will and Design of Experimental Studies/RCTs
also illustrate the principles for writing clearly and concisely in English through constructive peer Tutorial Lecture: March 28th 2024-Felipe Fregni-Program Staff and PPCR Program Director
review and discussion of participants’ draft research proposals. The dates are August 1-2, 2024, and it • Syllabus and discussion of the program format
will take place in Boston, MA. • Team introduction
• Sites introduction
• Using the Collaborative Learning Method: An overview
• Website tutorial
• Discussion
Optional Lecture: How to Maximize your Learning in PPCR, Tips from a PPCR Alumni:
March 29th 2024, 7:00am-8:30am
Office Hours/Group Discussion, April 10th 2024, 6:00pm-7:00pm
Lecture 1: April 11th 2024-Albert Hofman-Introduction to Clinical Trials
• Overview of clinical research (2nd lecture) Steven Freedman & Camilia Martin-Introduction to
Clinical Trials
• Why perform a clinical trial?
• What is a clinical trial?
• Phase I studies; Phase II studies; Phase III/IV studies
• Introduction to ethics of clinical trials
Optional Lecture: April 12th 2024, 7:00am-8:30am
Office Hours/Group Discussion, April 13th 2024, 9:00am-10:00am
Office Hours/Group Discussion, April 17th 2024, 6:00pm-7:00pm
Lecture 2: April 18th 2024-Gonzalo Patricio Labarca Trucios-Guide for Scoping and Systematic
Review/Literature Search/Databases/Critical Appraisal of the Literature
• Scope Reviews
• Systematic Reviews
• Literature Search/Databases
• Critical Appraisal of the Literature
Optional Lecture: April 19th 2024, 7:00am-8:30am
Office Hours/Group Discussion, April 20th 2024, 9:00am-10:00am
Office Hours/Group Discussion, April 24th 2024, 6:00pm-7:00pm
Lecture 3: April 25th 2024-David Wypij-Basic Study Design/Adaptive Design and Nof1
& Assessment of Bias in RCTs Tools (cochrane)
• Observational studies
• Randomized control studies
• Nonrandomized concurrent control studies
• Historical controls/databases
• Cross-over designs
• Factorial design

16 17
 • Studies of equivalence • Unblinded trials
• Large clinical trials • Single blind trials, Double blind trials, Triple blind trials
Optional Lecture: April 26th 2024, 7:00am-8:30am • Assessment of blindness
Office Hours/Group Discussion, April 27th 2024, 9:00am-10:00am Optional Lecture: May 31st 2024, 7:00am-8:30am
Office Hours/Group Discussion, May 1st 2024, 6:00pm-7:00pm Office Hours/Group Discussion, June 1st 2024, 9:00am-10:00am
Office Hours/Group Discussion, June 5th 2024, 6:00pm-7:00pm
Lecture 4: May 2nd 2024-David Wypij-Randomization Process & Blinding
• Fixed allocation randomization Lecture 9: June 6th 2024-Heather Baer-Confounders in Observational Studies: Using the method of
• Simple randomization propensity scores
• Blocked randomization • Motivation for propensity scores
• Stratified randomization • Definition of propensity score
• Adaptive randomization procedures • Main steps in propensity score analysis
• Mechanisms of randomization • Comparison of propensity score analysis with outcome models
Optional Lecture: May 3rd 2024, 7:00am-8:30am Optional Lecture: June 7th 2024, 7:00am-8:30am
Office Hours/Group Discussion, May 4th 2024, 9:00am-10:00am Office Hours/Group Discussion, June 8th 2024, 9:00am-10:00am
Office Hours/Group Discussion, May 8th 2024, 6:00pm-7:00pm Office Hours/Group Discussion, June 12th 2024, 6:00pm-7:00pm
Lecture 5: May 9th 2024-Felipe Fregni-Intention to Treat Analysis and Missing Data Lecture 10: June 13th 2024-Felipe Fregni-Selection of the Questions and Intro to Group Project
• Missing data • Primary question
• Intention-to-treat analysis • Secondary questions
• Covariate adjustment • Adverse effects
Optional Lecture: May 10th 2024, 7:00am-8:30am • Ancillary questions
Office Hours/Group Discussion, May 11th 2024, 9:00am-10:00am • Natural history
Office Hours/Group Discussion, May 15th 2024, 6:00pm-7:00pm • Frequent errors
Optional Lecture: June 14th 2024, 7:00am-8:30am
Lecture 6: May 16th 2024-Lidia Moura-Safety, Clinical and Surrogate Outcomes & Interventions Office Hours/Group Discussion, June 15th 2024, 9:00am-10:00am
• Reliability of measurements
Office Hours/Group Discussion, June 12th 2024, 6:00pm-7:00pm
• Validity of measurements
• Introduction to safety, clinical, and surrogate outcomes Lecture 11: June 20th 2024-Felipe Fregni-Publicly Available Datasets and Real World Data
Optional Lecture: May 17th 2024, 7:00am-8:30am • Publicly Available Datasets Examples
Office Hours/Group Discussion, May 18th 2024, 9:00am-10:00am • How to use and conduct data analysis in Public available data sets
Office Hours/Group Discussion, May 22nd 2024, 6:00pm-7:00pm • Ethics of publications of Public available Data sets
• Why is Real World data important
Module 2 – Observational Studies: Design and Critical Appraisal and Introduction to • How to use Real World Data
Publicly Available Datasets and Real World Data Optional Lecture: June 21st 2024, 7:00am-8:30am
Lecture 7: May 23rd 2024-Heather Baer-Observational Studies & Tool for Assessment of Bias in OS Office Hours/Group Discussion, June 22nd 2024, 9:00am-10:00am
• Overview of observational studies (cross-sectional studies, cohort studies, and case-control studies) Office Hours/Group Discussion, June 26th 2024, 6:00pm-7:00pm
• Confounding in observational studies Lecture 12: June 27th 2024 Mark Barnes-Integrity in Research
Optional Lecture: May 24th 2024, 7:00am-8:30am • Disputes about authorship - when authorship fails
Exam 1: May 25th 2024, 9:00 am • The right or otherwise to publish data, patents, and grant funding
Office Hours/Group Discussion, May 29th 2024, 6:00pm-7:00pm • Scientific integrity and misconduct
Lecture 8: May 30th 2024-Michele Hacker-Study Population and Selection Bias • Publication practices
• Definition of study population • Conflict of interest
• Issues on generalization Optional Lecture: June 28th 2024, 7:00am-8:30am
• Trade-off: Internal validity vs. external generalizability Office Hours/Group Discussion, June 29th 2024, 9:00am-10:00am
• Examples from landmark studies Office Hours/Group Discussion, July 3rd 2024, 6:00pm-7:00pm

18 19
Lecture 13: July 4th 2024-Felipe Fregni-Special Lecture: Mid-Check Review Lecture 18: September 19th 2024-Felipe Fregni-Statistical Tests III
• Group Project and Mini Review - Discussion and Feedback • Parametric and Nonparametric tests for more than two group comparisons
(Analysis of variance(ANOVA) and Kruskal-Wallis)
Exam 2: July 13th 2024, 9:00 am
Optional Lecture and STATA Review: September 20th 2024, 7:00am-8:30am
6-Week Module 3 – Group Project-Designing a Grant Proposal & July Workshops Office Hours/Group Discussion, September 21st 2024, 9:00am-10:00am
Group Project Meeting 1: July 11th 2024, 5:00pm-6:00pm-Introduction, PICOT Office Hours/Group Discussion, September 25th 2024, 6:00pm-7:00pm
Group Project Meeting 2: July 18th 2024, 5:00pm-6:00pm
Group Project Meeting 3: July 25th 2024, 5:00pm-6:00pm Module 5 – Other Study Designs and Analysis Tools for Grant Proposals
Group Project Meeting 4: August 1st 2024, 5:00pm-6:00pm Lecture 19: September 26th 2024-David Wypij-Non-inferiority Designs and Pragmatic Trials
Group Project Meeting 5: August 8th 2024, 5:00pm-6:00pm • Superiority trials
Group Project Meeting 6: August 15th 2024, 5:00pm-6:00pm • Non-inferiority designs
Module 4 – Basic Statistical Analysis for RCTs and Observational S tudies • Goals of non-inferiority designs
Office Hour/Group Discussion, August 21st 2024, 6:00pm-7:00pm • Choosing the non-inferiority margin
Lecture 14: August 22nd 2024-Roger Davis-Statistics-Basics Optional Lecture: September 27th 2024, 7:00am-8:30am
Exam 4: September 28th 2024, 9:00 am
• Data classification
• Data distribution Office Hours/Group Discussion, October 2nd 2024, 6:00pm-7:00pm
Lecture 20: October 3rd 2024-Jessica Paulus and Gonzalo Labarca-Sample Size Calculation and Meta-
• Descriptive methods for categorical data analysis
• Descriptive methods for continuous data • Dichotomous response variables
Optional Lecture and STATA Review: August 23rd 2024, 7:00am-8:30am • Sample size for continuous response variables
Office Hours/Group Discussion, August 24th 2024, 9:00am-10:00am • Sample size for equivalency of interventional studies
Office Hours/Group Discussion, August 28th 2024, 6:00pm-7:00pm • Estimating sample size parameters
Lecture 15: August 29th 2024-E. John Orav-Statistical Tests I • Practical Example: How to calculate sample size for a grant application
• Estimation of parameters • Subgroup analysis
• Comparison of population means (student t-test) • Comparison of multiple variables
• Nonparametric tests for two group comparisons (Mann-Whitneyand Wilcoxon Signed Rank Test) • Meta-analysis of multiple studies
Optional Lecture and STATA Review: August 30th 2024, 7:00am-8:30am Optional Lecture and STATA Review: October 4th 2024, 7:00am-8:30am
Office Hours/Group Discussion, August 31st 2024, 9:00am-10:00am Office Hours/Group Discussion, October 5th 2024, 9:00am-10:00am
Office Hours/Group Discussion, September 4th 2024, 6:00pm-7:00pm Office Hours/Group Discussion, October 9th 2024, 6:00pm-7:00pm

Lecture 16: September 5th 2024-Felipe Fregni-Correlation/Linear Regression/Confounding Lecture 21: October 10th 2024 - Roger Davis - Survival Analysis
Adjustment and Effect Modification • Estimation of the survival curve (Kaplan Meier estimate)
• Correlation (Pearson and Spearman correlation coefficient) • Comparison of two survival curves
• Adjusted analysis and predictors • Covariate adjusted analysis
• Introduction to multivariate analysis (analysis with more than one independent variable) • Use of survival analysis in clinical research
Optional Lecture and STATA Review: September 6th 2024, 7:00am-8:30am
Office Hours/Group Discussion, September 7th 2024, 9:00am-10:00am Optional Lecture and STATA Review: October 11th 2024, 7:00am-8:30am Office Hours/Group
Office Hours/Group Discussion, September 11th 2024, 6:00pm-7:00pm Discussion, October 12th 2024, 9:00am-10:00am

Lecture 17: September 12th 2024 -E. John Orav -Statistical Tests II Module 6 – Clinical Research Project Execution and Dissemination
• Chi-square and Fisher’s exact test Office Hours/Group Discussion, October 16th 2024, 6:00pm-7:00pm
• Trend test for categorical data Lecture 22: October 17th 2024-Donald Halstead-Effective Communication in Clinical Research
Optional Lecture and STATA Review: September 13th 2024, 7:00am-8:30am • Principles of good writing
Office Hours/Group Discussion, September 14th 2024, 9:00am-10:00am • How to write a paper
Office Hours/Group Discussion, September 18th 2024, 6:00pm-7:00pm • IMRAD
Optional Lecture: October 18th 2024, 7:00am-8:30am
20
21
Exam 5: October 19th 2024, 9:00am
Optional 3-Day Advanced Statistical Workshop, Boston
Makeup Exam for Module 4 or Module 5: October 24th 2024, 3:00pm Office Hours/Group Discussion,
This workshop provides additional statistical training for PPCR participants who want to acquire more
October 23rd 2024, 6:00pm-7:00pm
advanced methods especially in how to design and analyze studies using multiple variables (multivar-
Lecture 23: October 24th 2024- Dan L. Longo -Preparing Impactful Paper and Proving Peer Review - iate analysis). Participants will not only review and expand their statistical knowledge but will be able
Presentations and Graphs to apply their skills to their own research. During the workshop, participants will learn how to work with
• General tips and recommendations for writing strong and impactful papers data sets, fit a model, conduct statistical tests in STATA, and read and interpret the STATA output. After
• Peer review of manuscripts the workshop, participants will be familiar with the challenges, limitations, and issues of analyzing data
• How to perform quality peer reviews and interpreting the results, which will help them to better read the scientific literature, review manu-
• How to design effective posters and choose the ultimate graphs/figure for your studies scripts, and write their own manuscripts and grants. Agenda subject to change.
• How to effectively present abstracts and pass your message in research conference
Optional Lecture: October 25th 2024, 7:00am-8:30am Optional 2-Day Research Manuscript Writing Workshop, Boston
Office Hours/Group Discussion, October 26th 2024 9:00am-10:00am This intensive workshop introduces participants to essential concepts and tools for writing and pre-
Office Hours/Group Discussion, October 30th 2024, 6:00pm-7:00pm paring research manuscripts. Focusing on the PPCR manuscript writing, participants in this collabora-
tive-learning workshop will gain significant new insight into the logical structures and narrative path-
Lecture 24: October 31st 2024- Steven Freedman- Funding & IRB
ways of persuasive arguments that are essential to effective manuscript writing. We will also illustrate
• What are the important components in a grant research proposal
the principles for writing clearly and concisely in English through constructive peer review and discus-
• How to convey your message effectively in a grant proposal Institutional review boards (IRB)
sion of participants’ draft research proposals.
• How to find grant opportunities locally and internationally
• What is the main structure of an IRB and How is the review process in a IRB in the US
• What is important to include in the research informed consent form (ICF) Module 7 - 5-Day Immersion Course
The 5-Day Immersion Course is the capstone of the PPCR program. It is a highly interactive course
• What are the challenges for international research collaboration for the IRB
hosted by Harvard and other Boston area professors who will intensively review, discuss, and bring
Optional Lecture: November 1st 2024, 7:00am-8:30am
Office Hours/Group Discussion, November 2nd, 9:00am-10am together all the important information presented throughout the year, and give students practical ex-
• Office Hours/Group Discussion, November 6th, 6:00pm-7:00pm perience in clinical trial design and analysis. Another important aspect of this live course is that stu-
Lecture 25: November 7th 2024- Howard Sesso-Multicenter Trials and Academia Collaboration dents will meet with the faculty to review their group projects. An important component is helping you
• Challenges for Multicenter Trials through the peer review process, learning practically this process and helping during the publication
• Data Monitoring steps for those who choose to submit it to a journal. The 5-Day Immersion Course is an important com-
• Site Selection ponent of PPCR, and all students are encouraged to attend. The 5-Day Immersion Course takes place
• Funding and regulatory issues. usually in Brazil, however the definitive location will be announced in August.
Optional Lecture: " Participant Adherence and Recruitment: "November 8th 2024, 7:00am-8:30am
Office Hours/Group Discussion, November 9th 2024, 9:00am-10:00am
Office Hours/Group Discussion, November 13th 2024, 6:00pm-7:00pm
Lecture 26: November 14th 2024-Felipe Fregni-Special Panel: RCT vs. Observational Designs-
How do you Choose?
• RCTs-why would you choose this design?
• Observational studies-why would you choose this design?
• RCTs-why would you choose this design?
• Observational studies-why would you choose this design?
Optional Lecture: November 15th 2024 , 7:00am-8:30am
Exam 6: November 16th 2024, 9am
Exam 7 (Optional Exam): November 28th 2024, 9:00 am
Module 3 (During the July Break)– Group Project -Designing a Grant Proposal
July 11th-August 15th, 2024: There will be a six-week break with no lectures. This break is designed for
participants to work on the group project and start of the data analysis project. There will be mandatory
weekly meetings moderated by the TA-II to discuss progress on the group project. Participants should
also use the discussion platform (Ryver) to communicate about group project.
22 23
WEEKLY TASKS SYLLABUS
Weekly Routine Grading and Pass-Fail Criteria
Each week you will be expected to accomplish certain tasks. The main tasks during the week are: Participants are required to complete the following to earn a grade:
• Read the required material (especially the case study that was prepared specifically for this program) • Forum Participation (at Ryver): 350 points
• Post at least 5 different posts on the discussion forum - at Ryver platform(two of them being before • Exams (five): 100 points
Tuesday noon ET, Boston time) and two of them replying to your colleagues post • 3 Research Papers: 350 points– divided as:
• Complete the weekly assignment o Mini Review Paper: 100 points.
• Come prepared for the lecture as you might be called by the instructor to comment on the case o Data Analysis Paper: 100 points.
• Attend and participate in the weekly live lectures (Thursdays from 4:00pm to 7:00pm ET (Boston time)) o Research Grant Proposal Paper: 150 points, of those 50 points for finalizing the project and 100 points for the
work during the 5-Days workshop. This final grade will be the grade given to the project by the faculty,
• Participate in the Mini Review, Group project and Data Analysis Project according to the deadlines
multiplied by your participation. This means that for high participation students: your group grade will be
NOTE: The deadline for the weekly activities is at 4pm ET (Boston time), prior to the lecture. multiplied by 20%, not exceeding total of 150 points. For average participation students, your group grade will
There are several optional activities that you can attend to enhance your learning: remain as is (no multiplier change). For poor participation students, your group grade will be multiplied by-20%
1. Office-hours/group discussion: an excellent opportunity to interact with our TAs and your (meaning a decrease of 20%). Participation grade will be given by your TA based on your RyverChat (group
project forum space) and meeting discussions.
group members and solve your questions. There will be two Office Hours (via Web-based remote
• Homework Assignments: 100 points
access in Zoom) during the week, on Wednesdays at 6pm, and Saturdays at 9am EST, (Boston time).
• Lecture Participation and Jamboard: 75 points
2. Optional lectures/STATA reviews on Fridays (via Web-based remote access) from 7:00am to • Lecture – Formulating a Question: 25 points
8:30amET (Boston time). • Total Points Possible: 1000 points
3. Work on an individual clinical research project (in addition to the group project) to be presented
at the end of the program for additional bonus grading (optional but strongly recommended for Pass-fail grading will be based on the final grade. A satisfactory grade is considered to be above 75% (750 points).
those who will not be able to attend the 5-Day Immersion Course). At the end of the program, a certification letter will be given only to participants with satisfactory lecture’s attendance
(minimum 75% of the lectures) and grade. You can only have 8 lecture absences. Note that during the program, for
4. Review lecture material (PowerPoint presentations and recorded lectures).
each module, extra bonus assignments will be given to recover points. Tutorial Lecture is not counted towards
In addition, during the program you will complete the group project and mini review (coordinated with attendance, however it is highly recommended that you attend.
your group) and participate in the study group sections. Lastly, make sure you are well prepared for the Certificate: We will provide a hard-copy of the certificate for the students who attend the 5-Day Immersion Course,
module exams. during the ceremony. Otherwise, a PDF electronic certificate will be sent to your email by the end of the program,
with instructions on how to print it.
Case Study *Participants who cannot attend the 5-Day Immersion Course can earn the 50 points through an individual
For each week, participants will be required to read a case that was developed by the faculty on the topic project. Itis not impossible, but in our experience, we have seen that it is quite difficult to pass without either one of
of the lecture. The goal of the cases is to give an example of a real life situation based on the topics being theseactivities (individual group project or 5-Day Immersion Course). So, if you cannot go to the 5-Day Immersion
discussed that week. Cases will then be examined before and after each lecture. Be prepared for the Course(which is highly recommended), make sure you complete and present the individual project, if you are
discussions as you may be called upon to defend your ideas. You are also required to post your interested incompleting this program successfully. In our experience students who do not do any of these, need on
comments about the case on the forum and vote in the poll. average aweekly grade average (for the entire year) of 90% or above and exam grade of an average of 50% or more
for all the exams. We recommend you to track your performance in your individual grading sheets.
Reading Material Important: the program staff and the program director are here to help you complete the program successfully. If, for
The link for the required text for every lecture will be provided to you on the website. We recommend some reason, you experience any issues during the program that prevents you from completing activities regularly,
some additional readings, but they are optional (most of the material are from the two required books). please contact us as soon as possible so we can assist you. In the past, we had participants that struggled, but
waited until after the program finished and only then informed us that issues during the program prevented them
Office Hours/Group Discussion from participating and getting the necessary grades. At that point, it usually was not possible to help as program
We will hold Office Hours/Group Discussion meetings to discuss the weekly topics. Office Hour/Group activities were over.
Discussion meetings are important components of the program as they bring together the participants
from the same group in live discussions with their TAs. We encourage you to participate in these
meetings. There will be two Office Hours during the week. These meetings will take place at 6:00pm ET
(Boston time) on Wednesdays and at 9:00am ET (Boston time) on Saturdays.

24 25
 Grading Criteria for Paper 1 - Mini-Review (or full review)
GRADING BREAKDOWN At the end of the Mini-Review, we will send a form following the ICMJE author’s policy, and we will
grant grading to those who qualify as an author. The group might earn up to 50 points for the first
Forum Exams Assignment Lecture Lecture Bonus Group Mini Data 5-Days/ Faculty/ Pre/ Post Total complete draft submission, and another 50 points for reviewing and addressing the comments
Student Form Assignment Project Review Analysis Individual Staff Course Points received and the work done at the final preparation stage for the journal submission.
Part Question Project Project Grade Assignment
Module 1 84 20 24 18 6 152 Grading Criteria for Paper 2 - Group Project - Designing a Grant Proposal
Although there will be no attendance counted towards the program, attendance will be used for
Module 2 84 20 24 18 6 100 152
grading your individual participation in the group project development. You will get 50 points for the
Module 3 70 20 20 15 5 130
completion of the initial draft and 100 points for your work in the 5-Days Immersion Course.
Faculty and teaching staff will grade the group project. Your participation will also be measured by
Module 4 42 20 12 9 3 86
participation in the discussion platform (group project section) by the TA-II coordinating and
mentoring your group’s project, attendance in the July/August group project meetings, and also by
Module 5 70 20 20 15 5 100 130
individual self-assessments. Your group should respect the milestones and deadlines (date and time
Module 6 50 250 because delay in the group project submission can affect the overall group’s grade. Further
instructions will be given during Module 1. The submission period closes at 4:00pm ET (Boston time
Module 7 100 60 on the specified deadline)
Faculty/ TA Grading Criteria for Paper 3 - Data Analysis Project
Similar to the Mini Review, at the end of the Data Analysis Project, we will send a form following the
Pre/ Post ICMJE author’s policy, and we will grant grading to those who qualify as an author. The group might
Assignment
earn up to 50 points for the first complete draft submission, and another 50 points for reviewing and
addressing the comments received and the work done at the final preparation stage for the journal
Total Points 350 100 100 75 25 0 150 100 100 0 0 0 1000
submission.
Bonus 100 50 24 16 190 Grading Criteria for the Homework Assignments
You will need to complete the entire assignment to receive a full grade. Remember,
assignments are to be completed individually and will be corrected by teaching assistants who will
Bonus Points: provide you with feedback. The submission period closes at 4:00pm ET (Boston time every Thursday,
1. A maximum of 190 additional bonus points* will be rewarded if following tasks are completed: before the live lecture. Assignments are accepted for credit only when successfully submitted through
Bonus assignment (100 total points): these points will be distributed as following: the program website and within the deadline.
• 32 total points for Bonus assignment where you will create a review of any of the lectures, that
you decide, of the corresponding module. We will give more details of this assignment during the Grading Criteria for Faculty and Staff Grade
program. For the faculty and staff grade, you will be graded based on your live participation during the program
• 18 total points for Module evaluation distributed as following: lectures. For every lecture we will invite two groups to come, participate, and become panelists so you
• For the Modules 1, 2, 4 and evaluation, each completed evaluation earns 2 bonus points can discuss, interact, ask and answer questions to Harvard Faculty. You will be required to open your
(8 total points for the 4 modules evaluation) camera and participate. There will be a test of the connection the Tuesday prior to the lecture, and we
• For the Module 6 evaluation, the complete evaluation earns 10 bonus points. 18 total points will also discuss the lecture content so you can prepare. If you can’t come to the lecture we invite you
• 50 total points for activities that will be announce during the program to, you can request to come to the next lectures with other group.
2. Project Bonus Points: 50 total points: You can earn up to 24 points, and the points will be distributed as follow:
• Option 1: Actively participate in the 5-Day Immersion Course: 50 points • 24 points: you participate in three or four lectures
• Option 2: Give an oral presentation of the individual project with oral questioning from faculty: • 12 points: you participate in two lectures
50points • 6 points: you participate in one lecture
3. Pre- and Post- Program Assignment: 16 points (8 for each assignment) • 0 points = no lecture participation
4. Faculty and Staff Grade: 24 points
Because of time please note that probably not all of you might be called, nonetheless you will receive
Bonus points are added to the final grade; however, total points cannot exceed 1,000 points. your points for joining live as a panelist.
26 27
Grading Criteria for Lecture Participation
To ensure critical participation during lectures, you will be asked to post a short comment online during
FORUM
each period of the lecture. The three-hour lecture will be divided into two periods: 1. 4:00pm-5:30pm and The online forum is a tool to help participants learn and grow through interaction with colleagues.
2. 5:30pm-7:00pm. The specific period for posting will be announced during the lecture and will vary with We will provide thought provoking material on the upcoming lecture. We expect you to post your
each lecture. You will have five minutes to write your response. Please note that if you come late to the comments and ideas and your input will be evaluated. The forum is not a place to copy and paste
lecture and the period for posting has passed, you will not be able to post. If you successfully complete articles, other people’s work, or simply just “agree” with your colleagues. We want to know your
these posts during class, you will receive 50 points as detailed in the grading section. If you do not thoughts. Use this space to interact on a deeper level to increase your and your colleagues’
complete them successfully, your points will be adjusted proportionally. For 25 points more, during each knowledge and understanding of clinical research. We expect that you check and participate in the
lecture you will use Google Jamboard as note taker, and submit your final canvas (you can download your forum at least once every two days on average (this will not take too much of your time if you have
notes in Jamboard as a pdf. Jamboard is an interactive whiteboard that allows you to sketch your ideas studied the materials).
and style them as you desire. Each lecture canvas submission is one point. At the end of the program you Grading Criteria for Posts in the Forum
will have your book. The forum is an important component of your grade; therefore, make sure you participate in the forum
Grading Criteria for Formulating a Question every week. You will get a grade every week from 0% to 100% according to your participation that will
At the end of each Lecture, you will have to create a question related to the lecture and submit it in the be defined by the following:
Google form that will be available for this purpose. This question should be individual work. Some • 1 valid post: 30%
questions will be selected and the student will be called to ask the question live. As there are 25 lectures, • 2 valid posts: 45%
you will receive a maximum of 25 points as detailed in the grading section or one point per question per • 3 valid posts: 55%
lecture. If you do not complete them successfully, your points will be adjusted proportionally. • 4 valid posts: 70%
• 5 or more valid posts: 100% (OR 10.5 points)
Grading Criteria for Pre-Program and Post-Program Assignment
You will be graded on whether you responded to all of the questions on the assignment before and after In order to get full participation in the forum (or 3.5 more points per week), you need to have 5 or
the program. This assignment is individual work. The submission period closes at 4:00pm ET (Boston time more valid posts and complete one of the following additional step:
1. You need to have at least two valid posts before Tuesday at 12:00pm (midday) noon ET (Boston time),
on the date of the deadline.
and to respond to two colleagues’ posts, or
Grading Criteria for Bonus Assignment for an Article Review Assignment 2. Create a small video about the topic being discussed and share it as a post. Try to keep your video
In each module, there will be one “Module Bonus Assignment”, and students will earn a maximum of and message short (less than 5 minutes). You will need to upload your video either in a private server
eight points. It is highly recommended to complete it, as it will help your long-term learning on this topic (such as Dropbox) and then share the link or in social media (such as YouTube, Instagram, Facebook,
etc.) and then share the link. This is not a requirement, but we know that a video increases social
and enhance your critical thinking. The Bonus activity will be to review one of the lecture of the module,
interaction with your peers, thus enhancing learning, and also improves your reflection about the
discussed an article you choose related to it, and present it in a video, power point or poster. The detail
topic. So, we encourage and thus give extra credit for this activity. There is a forum that discusses
instructions will be published by the end of each module. how to create and upload a video and then post the link in the PPCR forum. If you have any
Each Module Bonus Assignment has a date and time to open and close. Be attentive to the schedule questions about how to create and upload a video, please contact us. Finally the best video of the
and instructions. week will be shared with the entire group as a source for all PPCR students.

Grading Criteria for Project Bonus Points Importantly, in order for a post to count as valid:
There are two options for receiving the final bonus points: 1. It needs to have content: for instance, posts such as “I agree with Peter,” or “this was a nice
comment,” or “I also believe randomization method is the best approach,” will not be counted as
• Option One: 5-Day Immersion Course Participation: If you attend the 5-Day Immersion Course and have
there is no content. You can write instead: “I agree with Peter because this, that. And that…” The idea
an active participation in all the activities, you will be given up to 50 bonus points, as assessed by the is to generate and support a discussion.
faculty interacting with you (in addition to the regular 100 points given for the group project or individual 2. Posting in succession: comments made in succession will be counted as one post if it is clear that
project if you couldn't attend the 5 Days). the participant has divided the comment in order to increase the quantity of their posts even if the
• Option Two: Individual Project Presentation to Faculty: If you do not attend the 5-Day Immersion purpose is to better organize the arguments, or if the student is answering different colleagues about
Course, you have the option of completing an individual project as approved by the Program Director. the same matter. We consider quality and not quantity for post validation.
The individual project is worth up to 100 regular points as assessed by faculty and plus 50 points for
originality, novelty and presentation and discussion with faculty. More details about the individual
projects will be given after the completion of the group project and the schedule of the bonus oral
presentation will be defined according to the number of submissions, after the 5-Day Immersion
Course. The date for the Individual project presentation will be announce during the program.
28 29
 3. The content from the post should be original. If some text is copied from another source (even if just • Use informative keywords in your title. To help the other participants, be sure that your title clearly
a few words), the source must be acknowledged (author’s name, article, journal and link) and the text indicates the content that will follow. “My ideas about today’s readings” isn’t nearly as clear as “Joe
included between quotation marks (“…”). If non-original content is detected without proper citation,
should disclose to his manager.”
the post will not be considered valid for grade. See also Harvard Guide to Use Source at:
• Make postings short and purposeful. Long messages are difficult to read online. Another rule of
https://usingsources.fas.harvard.edu/avoiding-plagiarism
thumb is to make only one main point in each posting, supported by evidence and/or an example.
The TAs use the following codes (emoticons) for Post assessment: Again, be concise.
• Your stance need not be yours forever. It can be intimidating to take a stand on an issue at times,
especially when you put it in writing, which we associate with permanence. Remember that you are
allowed to change your mind! Simply indicate that with the new information raised in the discussion,
you have changed your stance. Learning is about change.
“Grey Check Mark”
Post has been reviewed Responding to Other Posts
• Make the context clear. An informative title will help, but also consider including a quotation from
“Green Star” the original message to which you’re responding. If the original message is lengthy, cut out what
Post is valid for grading is not relevant to your response. And if the original has many paragraphs, place your comments
between the paragraphs to give readers the context for your ideas.
“Trophy” • Add value to the conversation. Saying “I agree” does not move the discussion forward. Ask yourself
Outstanding quality post why you agree and explain your rationale so that others have something else to respond to.
• Ask probing questions. Consider using the following samples when trying to extend a discussion:
o What reasons do you have for saying that?
o Why do you agree (or disagree) on that point?
o How are you defining the term that you just used?
The TAs and faculty will be adjusting your forum grade based on the content of your comments, o What do you mean by that expression?
respecting the course policy. o Could you clarify that remark?
o What follows from what you just said?
o What alternatives are there to such a formulation?
Student Collaboration/Tips for Forum Posting
• Feel free to disagree with your classmates. To air different perspectives or help others clarify
As we emphasize during the entire program, this is a collaborative learning program. We designed
their thinking, you may need to contradict a classmate. Remember to disagree respectfully (no
the program to provide many opportunities for collaboration. The forum is one of the main platforms
name-calling or obscenities) and support your point with evidence, but do not feel bad about offer-
for collaborating. In addition, you are required to develop a project with your group. Throughout the
ing a different interpretation. Your contribution should help to make the discussion more productive
course, you are also encouraged to form study, reading, or discussion groups. These can be live
for all involved.
groups (for students at the same site) or they can be virtual groups. Collaborative learning is one of the
• Work to create group cohesion. Discussions are about group learning. When you function well as
most effective methods to consolidate and enhance your learning. Effective learning is usually
a group, you will be more open to all the benefits that this type of learning can offer. Give positive
associated with co-construction or, in other words, participants working together in a process of
feedback to one another, use light humor, avoid comments that could be taken as insulting, use first
constructing shared knowledge.
names, respond promptly to each other, and offer assistance. Also remember the lack of nonverbal
We show below some tips for online discussion (from the document Trace: University of Waterloo, and vocal cues in the online environment. You’ll need to label emotions (“I’m confused about this”
Ontario, Canada): or “I feel strongly”) because no one will pick up on how you feel otherwise.
• If you feel very emotional about a message, wait before responding. It’s very easy to write some-
Writing a Post
thing in the heat of the moment and then wish you could retract it. If you send it to the discussion,
• Be strategic. Online discussions can generate a number of messages, so you need to consider
the damage is done. Even waiting overnight can give you enough distance to respond in a calmer
efficient ways to make your contributions. For example, after you’ve done the required reading or
and more professional manner.
task, think of a thesis and how to support it, then read the other postings and see how they support
or contradict your idea, and write about this.
• If you’re the first to post, strive to encourage discussion. Get others thinking (and writing) by making
bold statements or including open-ended questions in your message. Those who post first are most
often responded to and cited by others. Remember to check back to see if and how others have
responded to your ideas.
30 31
 EXAMS
Exams and Makeup Exams
Participants are expected to take exams at the times scheduled. Exams will be held on Saturdays at
9am ET (Boston time. There will be two Makeup Exams, which will be more difficult than the original
exam and held prior to the Thursday lecture (3:15pm). The “Module 1 and 2 Makeup Exam” will be given
in the middle of the program (as Makeup Exam 1 or Makeup Exam 2) and the “Module 4 and 5 Makeup
Exam” will be given before the first lecture of Module 6 (as Makeup Exam 4 or Exam 5). Possible ex-
ceptions for the exam include serious illness, family emergency, or a legitimate conflict with recognized
program activities. If these exceptions apply, you must contact the program coordinator to request a
makeup exam before the scheduled exam occurs. Please note that if you do not request permission
to take the makeup exam before the scheduled exam occurs, you will not be given the opportunity to
take the makeup exam.
In the event you miss Exam 1 and Exam 2 or Exam 4 and Exam 5, the “Module 1 & 2 Makeup Exam” and
“Module 4 & 5 Makeup Exam” will then replace the first missing exam, that is, for Exam 1 and Exam 4,
respectively. However, you will have the option to take the optional final Exam 7 to replace the second
missing exam.
You will have 45 minutes to complete the exam. The exam closes 45 minutes after it begins; if you are
late for the exam, you will have only the remaining time to complete it. The exam format will be defined
ASSIGNMENT before the course starts.
Assignment
Please note that you will be responsible for finding a suitable place with reliable Internet service to
For each week, besides the forum participation, there is an assignment to submit in the course
take the exams. We recommend that you test your connection before the exam day to make sure you
website. This should be done as individual work and be unique. However, students are welcome to
will not have Internet issues during the exam.
discuss the assignment questions with their colleagues. If a student copied part of or used the
information from a source, he/she should cite it properly according to Harvard Guide to Use Source After the last module, we will offer one optional final exam, this is Exam 7. The final exam will be offered
(please check at “Academic Rules, Rights, and Responsibilities”). We assess electronically the content to all participants and can be used to 1) replace your lowest exam grade [note: the final exam grade will
of the assignment and the same rules that apply to forum posts, apply for the assignment. The teaching be considered regardless of whether it is higher or lower than the lowest grade and the grade will be
assistant will correct your assignment and give you feedback. proportional to the module exam grade with the lowest number of correct responses] or, 2)act as a final
makeup exam for a case in which you were unable to attend the regular exam. The same exam policies
The deadline to submit your assignment is at 4pm ET (Boston time) prior to the live lecture. will apply.
Alternative Assignment Technical Problems During the Exam
Unexpected health problems may occur during the course. In this case, if your health problem lasts Please note that a limitation of a distance-learning course that uses the Internet as a way of
more than 3 weeks, during Modules 1, 2, 3 and 4, your case can be reviewed (e.g. maternity leave), with communication (including exams) is potential technical issues with the Internet. Regardless of the
a physician report or proper documentation and an alternative assignment can be required to intensive testing we do before and during the program, issues with the Internet cannot be 100%
recover up to 75% of the missing weekly grade (forum and assignment). The alternative assignment prevented. We will do everything we can to remediate these issues, but be aware that if you
and its deadline are determined by the coordinator, and the student will have one week to complete it experience an Internet problem, you will need to take the makeup exam. To take the makeup exam
when it is approved to do so. you cannot have started the regular exam. We will work with you to try to fix Internet problems and
Note that if this happens during Module 5, as this module is the last one, there will not be enough offer solutions on the day of the exam, but solutions might not always be possible. To have a better
time for the alternative assignment as it is near to the end of the course. If you have full participation in experience on your end, please test your Internet connection prior to the exam and close ALL other
Modules 1, 2, 3 and 4 weekly activities, did all the bonus assignments, actively participated in the group open applications on your computer. Having other programs open on your computer is a
project development, and did the exams, you still can pass the course by doing the individual project common problem.
and bonus oral presentation.

32 33
RESEARCH PAPERS PAPER 3 - DATA ANALYSIS PROJECT
As part of the program your group will conduct a data analysis project and write a manuscript reporting
PAPER 1 - MINI-REVIEW (OR FULL REVIEW) your design and results. You will analyze the data of an open-access data set aligned with challenge
For the Mini Review, each group will conduct a mini-review related to the challenge assigned to your
assigned to your group project and mini review. We will offer an optional session on open data sets.
group (or a full review is also welcome), you will design the review, define and present your search
This data analysis project will have up to 3000 words and should be submitted for publication.
strategy, evaluate the quality of the studies included in your analysis, report your results, discussion,
The data analysis project activities will start in August and should be completed and submitted by
and conclusions. This paper has the goal to enhance your systemic review and scientific writing skills,
early October.
and learn how to publish a scientific article. This mini-review will have up to 2000 words and should
be submitted for publication. The deadline for the final draft of the mini review is at the end of June,
2024. The program assignments will be related to the research papers, and each assignment will help
WEBSITE
The Principles and Practice of Clinical Research program will be highly interactive and will use the
you with one step of the Mini Review. Please see the Mini Review examples from previous years
program website for communication, turning in assignments, and downloading materials.The PPCR
below:
portal and website address for application is: ppcr.org
• Transcranial Magnetic Stimulation of Dorsolateral Prefrontal Cortex in Treatment-Resistant
Obsessive Compulsive Disorder: A Mini-Review By mid-March we will send you a ppcr.org email account to be used during the period of the program
https://journal.ppcr.org/index.php/ppcrjournal/article/view/289/292 (from March to November 2024) and it serves to access the PPCR Google Classroom and Ryver as
• The Effect of Spermidine Supplementation on Cognitive Function in Adults: A Mini-Review. well, where the program activities will take place. This email account will be used only during the
https://journal.ppcr.org/index.php/ppcrjournal/article/view/284/273 course and will close in December 2024. If you apply and are invited to become a TA you will keep
• Advances in Gene Therapy Treatment for Obesity: A Mini-review your ppcr email. Please be sure to familiarize yourself with the website.
https://journal.ppcr.org/index.php/ppcrjournal/article/view/294/298 Technical Requirements for Connection
PAPER 2 - GROUP PROJECT: GRANT PROPOSAL All participants must have a computer with excellent Internet connection (at least 1 Mbps) and a
Parallel to the Mini Review, for the Group Project, students will be divided into groups and work computer with at least 1.5 Ghz processor and 1 Gb RAM memory. The computer should also have a
together using the web-platform for communication (Ryver platform) to write a mock grant proposal webcam and microphone. For browsers, we recommend Google Chrome, as other browsers may not
using the research methodology studied in the program. To find more information about the group support an adequate connection or visualization of all the website features. Furthermore, host sites
project, please go to the group project instructions on the program website. must have videoconference technology and technicians.
The Group Project starts in early May, by discussing your Group Project research question. You will
Importantly, we maintain a high-speed connection server for participants. If we experience any
need to develop the challenge that will be assigned to your group. There will be a group project
problems with our server connection, we will immediately inform participants. Unless we announce a
development period July through mid-August during which you will work with your group on the group
problem with our server, if you experience any breaks in your connection, please check your
project and study program content - especially the statistics content. During this period, there will be
equipment or local connection. One website that is useful to check your connection speed (there are
required weekly meetings on Thursdays with your TA-II to help you develop the project and give you
others) is http://www.speedtest.net.
some guidance. You are required to participate in these meetings. The program assignments will be
related to the research papers, and each assignment will help you with one step of the Grant
Proposal. The deadline for the final draft of the project is in the middle of Module 4 (mid-September
2024). Please see the Grant proposal examples from previous years below:
• PSORIATICUM: Topical Hypericum Perforatum for Moderate Plaque Psoriasis: Study Protocol for a
Randomized Controlled Trial
https://journal.ppcr.org/index.php/ppcrjournal/article/view/245/286
• DECREASE: Decrease Cognitive Decline inAlzheimer’s Disease Through Occupational Therapy: A
Randomized Controlled Phase III Trial Protocol
https://journal.ppcr.org/index.php/ppcrjournal/article/view/246/280
• Effects of Neuromuscular Electrical Stimulation in Patients with Post-Stroke Related Dysarthria: A
Double-Blinded, Phase-II Randomized Sham-Controlled Trial Protocol - ULYSSES Trial
https://journal.ppcr.org/index.php/ppcrjournal/article/view/263/254

34 35
LECTURES Attendance will be taken through the website. Absences will also decrease your participation for that
week (as a result of not being present and not being able to participate) and will result in a decrease in
Live Lectures your grade.
The live lectures will occur on Thursdays from 4:00pm-7:00pm ET (Boston time). These three-hour
lectures will include an interactive discussion about the weekly case study and poll, a one-hour lecture In addition, you are expected to stay until the end of the lecture (7:00pm). If you leave the class without
from Harvard faculty or invited guest, and time for questions and discussion with the lecturer. You can a justification, your attendance may not be considered for that day at the discretion of your site
attend the lectures in one of two ways: monitor. Importantly, for those who are near an on-site location (for instance, in Boston or São Paulo),
• If you live near a participating host site, then you will attend at that location. you must attend the course on site (rather than via web), unless you have been authorized by the
• If you do not live near one of those locations, then you will attend individually program director to attend via Web-based remote access before the start of the program. To get
via Web-based remote access. attendance in this case, you have to attend at least 2h45min of the live lecture and have full
participation in the activities during the lecture.
Lectures will be recorded, based on the speaker’s consent, to be watched again. Professor Fregni will
also give some of the lectures from participating international sites. The only exception is for business trips—in this case you can attend the course via Web-based remote
access and your attendance will be counted if you attend at least 2h45min of the live lecture. Business
Web-Based Remote Access Connection trips are usually trips to conferences or presentations or to give talks in other states or countries. Short
The PPCR program, as a distance-learning program, enables participants to attend lectures virtually if one-day trips (for instance, work meetings outside of the city) are not counted as approved business
there is no site near the participant’s location. All Web-based remote access participants must consider trips for attendance purposes. Business trips have to be corroborated with proof of conference
the recommended technical requirements for connection, in order to avoid potential problems during registration or other official documentation.
the lectures.
In order to receive attendance while on a business trip, you need to submit documentation of your trip
by emailing the Program Coordinators, who will assess your request. The deadline for the business trip
Seat Assignment in Sites exception request submission is at 12:00pm ET (noon-midday-Boston time), on Wednesdays prior to
In order for the faculty in Boston to recognize participants and thus promote interaction during the the day of live lecture. Your exception for a business trip will not be counted if these steps are not
lectures easily, participants will be assigned to the same seat throughout the entire program. Seat followed. If you are away from your site for any other reason (if you are sick, on vacation, etc.), we
assignments may be determined by the Site Director/Site Monitor or by the student in the first encourage you to still attend the program via Web-based remote access, but it will count as one
tutorial class. absence. If you have less than 75% attendance, you will fail the program. Note that if you will be on a
business trip for more than one lecture, you will need to submit a new request for each lecture.
Responsible Use of Computers During Class
Laptop use is encouraged during classes to increase interaction during Q&A and discussion periods. Frequently Asked Questions:
However, we urge participants to restrict computer use to program-relevant activities. You may distract • I am from a site center and I am on call, but I can connect in the hospital and follow the entire
your colleague sitting near you if you use your computer to do non-program activities during class. lecture in Web-based remote access option with full participation. Can this be counted as
Additionally, running other non-program applications may affect the efficiency of your Internet attendance? No, your attendance will not be counted, as you are expected to be at the site during
connection. Even if you are using a Web-based remote access connection (not at a site), the instructor that time with all other participants. However, we encourage you to be connected to watch the
may call upon you anytime during class. In some sites, the Site Director may determine the policy on lecture and participate as usual. Remember, you can use one of your seven allowable absences for
the use of computers during lectures. Please also note that the use of cell phones is not allowed during situations like this.
the lectures. • I am from a site, and I am stuck in traffic. I can stop at a place with Internet and follow the lec-
ture from there. Can this be counted as attendance? No, your attendance will not be counted, as
Although you will be able to use smartphones or tablets to connect to the website and participate,
you are expected to plan accordingly and be at the site during that time with all other participants.
please be aware that these platforms do not offer all the resources of connecting via a laptop.
There is also a 30-minute window for unexpected delays. In extreme cases, such as a major event
in the city (as officially confirmed by the Site Director), then the situation will be considered by the
Attendance Boston program team. Also, we encourage you to be connected to watch and participate in the
You need to achieve 75% attendance; therefore, you are allowed to have only eight absences. In order lecture. Remember, you can use one of your seven allowable absences for situations like this.
to receive credit for attendance, you must be in the program before 4:30pm ET (the lecture begins at • I am from a site center and I have a business trip request approved, does this mean that I have
4:00pm ET) AND interact during the class answering the lecture participation activities that will be attendance for this lecture? No, your attendance will only be counted if you connect to the live
posted at Google Classroom (see Grading Criteria for Lecture Participation). lecture via the link that the course coordinator will provide to you and stay connected for at least
If you enter after 4:30pm, you may watch the lecture, but you will not receive attendance for that day. 2h45min and participate in all activities during the lecture
However, you are still welcome to participate during the lecture as this will reflect in your weekly grade.

36 37
 • I am from a site center and am suffering a health problem, can I receive attendance with remote Site Director (SD)
access for this reason? No. However, if your health problem last more than three weeks, your case The site director (SD) is the individual appointed by the institution collaborating with PPCR along with
can be reviewed (e.g. maternity leave, with a physician report). We encourage you to be connected PPCR as to be the site leader and thus be the individual ensuring that all the support students need for
to watch the lecture and participate as usual. Remember, you can use one of your seven allowable the live connection with Harvard are offered. The site director also offers educational support to
absences for situations like this. students along with site monitors and eventually TAs that are local to the site. Do not hesitate to also
ask help for your site director to any matter related to PPCR.
Friday Morning Lectures/STATA Reviews
On Friday mornings (following the Thursday class), we will hold optional sessions and Stata Reviews Teaching Assistants (TA)
with Senior TAs. They will be accessible only through Web-based remote access (not via the site Our program has a large number of Teaching Assistants (TAs) to ensure you will get the most out of
center)–you do not need to go to your center for these meetings. The Senior TAs will review lecture your PPCR experience. There are three levels of TAs: TA-I, TA-II, and Senior TA. Students will be
material and conduct a discussion with participants. Take advantage of these sessions, as they are a divided in groups of 35-40, and each group will be assigned to five or six TA-Is, three TA-IIs, and two or
great review of the topics discussed in the program. We do not count attendance for these optional three Senior TAs. Within your group, you will then be subdivided in subgroups of three to five students
Friday sessions (only for the Thursday lecture); however, we strongly recommend you attend them. and assigned to one specific TA-I who will be able to follow and assist you more closely.
One exception is for participants whose site is in a time zone that has an eight-hour (or more)
difference from Eastern Time (Boston time). For these participants, optional sessions and Stata Reviews Teaching Assistant I
will be counted as live attendance for the course. In order to receive attendance, participants must be The majority of TA-Is are in the first year of teaching assistantship in PPCR. They are previous students
in the program before 7:15am ET (the lecture begins at 7:00am ET) AND interact during the class. If you who greatly contributed to the program. All participants should make sure that they frequently interact
enter after 7:15am, you may watch the lecture, but you will not receive attendance for that day. It is a with their TA-I. The role of the TA-I is:
one hour and thirty minute lecture. 1. To be your first contact regarding questions about program material
2. To correct and provide feedback on your weekly assignment
3. To follow you in the weekly forum discussion and validate your posts based on program rules
4. To stimulate group interaction and to coach you in your learning of clinical research and
collaborative skills
Teaching Assistant II
TA-IIs are in the second or third year of teaching assistantship; they have additional expertise in the
PPCR content and methodology. Be sure to interact with them as well. The role of the TA-II is:
1. To coordinate and supervise the Group Project and follow its progress
2. To grade your performance during the Group Project
3. To hold weekly one-hour meetings called Office Hours via Zoom. These meetings are highly
recommended. You should bring questions and concerns to these meetings. You can direct any
question you have to your TA-II, and she/he will ensure it is directed to the appropriate faculty if
she/he does not have a response for you. Regarding questions related to the assignment, teaching
assistants are not allowed to give you the responses, but will help guide you as you think about
how to solve it.
Take advantage of the interaction with your TA-II, as she/he will be very important to your learning!
Senior Teaching Assistant
Senior Teaching Assistants are those teaching assistants who have been teaching assistants
previously (for more than two years) and continued as part of the teaching staff. The role of the Senior
Teaching Assistants is:
1. To teach optional sessions and Stata Reviews on Fridays mornings throughout the program to
provide practical examples of how the program content can be applied in your clinical
research practice
ADDITIONAL PROGRAM SUPPORT 2. To review the Group Project, along with the TA-II

38 39
3. Along with the TA-II, to answer questions during the Office Hour meetings. They will also be
available to answer any of your questions throughout the program.
ACADEMIC CALENDAR
Note: All lecture times are in Boston time (ET). Lectures are scheduled tentatively and are subject to
4. To coordinate and supervise the Optional Individual Project (for those students that cannot attend
change. Orange indicates required sessions, green indicates optional sessions, blue indicates optional
the 5-Day Immersion Course)
office hours, pink indicates the required exams, and red indicates the Group project meetings
5. Assess the Individual Project and the Bonus Individual Project presentation (for those student that
cannot attend the 5-Day Immersion Course) MARCH 2024
Note: Senior TA will not assess the individual project of their group of students. SUN MON TUE WED THU FRI SAT
24 25 26 27 28 29 30
Site Monitors (SM)
4 PM 7 AM
As most participants are in sites across different countries and may not be in the same location as our
TAs, we have site monitors, who are past students from PPCR who are qualified and trained to be at
the site to help participants who have questions regarding the program, including administrative and
content issues. Site monitors will provide assistance during exams, control attendance, and help APRIL 2024 JUNE 2024
provide feedback on the site’s performance. Take advantage of the site monitor at your site. Please SUN MON TUE WED THU FRI SAT SUN MON TUE WED THU FRI SAT
note, if you are in a newly established site, you might not have a site monitor. 31 1 2 3 4 5 6 1 2

7 AM 9 AM
WEBSITES – ONLINE PLATFORMS
• PPCR Website: Uses the Google Classroom platform. 7 8 9 10 11 12 13 3 4 5 6 7 8 9

• Material: The readings and videos are provided as links from open access sources. The case 6 PM 4 PM 7 AM 9 AM 6 PM 4 PM 7 AM 9 AM
studies were written by the program staff to enhance your learning. There will be two required 14 15 16 17 18 19 20 10 11 12 13 14 15 16
books that you will need to acquire before program starts (most of the material will be there).
6 PM 4 PM 7 AM 9 AM
• Lecture Participation/ Formulating a Question: These will both be in a form in the PPCR platform. 6 PM 4 PM 7 AM 9 AM

Be sure you have a good Internet connection. 21 22 23 24 25 26 27 17 18 19 20 21 22 23

• Assignments: Assignments should be submitted through the website platform by the deadline. No 6 PM 4 PM 7 AM 9 AM 6 PM 4 PM 7 AM 9 AM
assignments sent by email will be accepted for grading.
28 29 30 24 25 26 27 28 29 30
• Office Hours (Zoom): We use Zoom Video Conferencing for our Office Hours. A link is provided in
the main PPCR program website. 6 PM 4 PM 7 AM
• Forum / Group Project: We use a team communication and task management web-platform (Ryver).
Take a look at these tutorials to familiarize yourself with this platform: MAY 2024 JULY 2024
https://ryver.com/feature-tutorials/.
• Exam: We will send a direct link for the exam. SUN MON TUE WED THU FRI SAT SUN MON TUE WED THU FRI SAT
• Lecture (Zoom): We also use Zoom Video Conferencing for the live lectures. Make sure you 1 2 3 4 1 2 3 4 5 6

familiarize with this platform before program starts, if you will be connecting remotely. 6 PM 4 PM 7 AM 9 AM 6 PM 4 PM 7 AM
• Attendance: Attendance will be recorded in the main PPCR platform. 7 8 9 10 11 12 13
5 6 7 8 9 10 11

6 PM 4 PM 7 AM 9 AM 6 PM 5 PM 7 AM 9 AM

12 13 14 15 16 17 18 14 15 16 17 18 19 20

6 PM 4 PM 7 AM 9 AM 6 PM 5 PM 7 AM

19 20 21 22 23 24 25 21 22 23 24 25 26 27

6 PM 4 PM 7 AM 9 AM 6 PM 5 PM 7 AM

26 27 28 29 30 31 28 29 30 31

6 PM 4 PM 7 AM 6 PM

40 41
 AUGUST 2024 SEPTEMBER 2024 Academic Rules, Rights, and Responsibilities
SUN MON TUE WED THU FRI SAT SUN MON TUE WED THU FRI SAT
ECPE Classroom Community Expectation
ExpectationThe Harvard T.H. Chan School of Public Health and the Center for Executive and Continuing
1 2 3 1 2 3 4 5 6 7
Professional Education respect the highest principles of scientific and academic conduct, foster open
5 PM 6 PM 4 PM 7 AM 9 AM inquiry, and honor individual rights. Our staff, faculty, and community members are committed to
4 5 6 7 8 9 10 8 9 10 11 12 13 14 ensuring that your educational experience is valuable, respectful, and safe.
5 PM 6 PM 4 PM 7 AM 9 AM
• It is important that participants, faculty, and staff understand and agree to the following ECPE
community expectations:
11 12 13 14 15 16 17 15 16 17 18 19 20 21
• We expect all in the community to act with respect and dignity towards all others. Intolerant,
5 PM 6 PM 4 PM 7 AM 9 AM disrespectful, or disruptive behavior towards others will not be tolerated and could result in
18 19 20 21 22 23 24 22 23 24 25 26 27 28 dismissal from the program.
• The faculty, staff, and fellow participants with whom you will work closely in the classroom are
6 PM 4 PM 7 AM 9 AM 6 PM 4 PM 7 AM 9 AM
professionals, and your relationship and communications with them should be strictly professional.
25 26 27 28 29 30 31 29 30 • Our learning is enhanced by professional experiences. Everyone must trust that confidential
6 PM 4 PM 7 AM 9 AM information shared during a program will not be shared outside the program, including photos,
videos and on social media.
• We expect our community members not to misrepresent their identities or their personal/
OCTOBER 2024 NOVEMBER 2024 professional records.
• It is a common practice in the United States that, in an academic setting where people are learning
SUN MON TUE WED THU FRI SAT SUN MON TUE WED THU FRI SAT
together and from each other, participants address each other and our faculty and staff by their first
1 2 3 4 5 1 2
or given names; this is not intended to be disrespectful or discourteous.
6 PM 4 PM 7 AM 9 AM 7 AM 9 AM • The School reserves the right to remove any applicant or student from the registration/admissions
6 7 8 9 10 11 12 3 4 5 6 7 8 9 process and program for engaging in, or having engaged in, conduct that faculty or staff determine
violates this code of conduct or otherwise negatively impacts the learning environment. The
6 PM 4 PM 7 AM 9 AM 6 PM 4 PM 7 AM 9 AM
cancellation policy will be applied in these instances.
13 14 15 16 17 18 19 10 11 12 13 14 15 16
• All other Harvard University–wide policies apply.
6 PM 4 PM 7 AM 9 AM 6 PM 4 PM 7 AM 9 AM
General Standards of Conduct
20 21 22 23 24 25 26 17 18 19 20 21 22 23
In establishing a standard of student conduct, the PPCR Team is committed to the basic principles of
6 PM 4 PM 7 AM 9 AM entrusting each student with a high degree of freedom to govern his or her life and conduct while
27 28 29 30 31 24 25 26 27 28 29 30
enrolled in the course.
6 PM 4 PM 9 AM Students are expected to respect the right of others while partaking in this online program. In this
international program, you will have the opportunity to interact with colleagues across the globe, so
please remember you are not only a representative of yourself, but also your country. The forum is to
remain professional and to be used for academic purposes.
The PPCR Team reserves the right to monitor, censor, or dismiss any participant whose conduct or
Office Hours Lecture 4 PM Optional 7 AM Exam 9 AM performance is considered a violation of standards. Such a decision will be made only after review by
the appropriate participant and faculty committees. During this review, the participant will have full
opportunity to present his or her position.
Group Project Meetings
5 PM - 6 PM Honor Code
The clinical research profession has high standards of integrity in the performance of professional
services. Just as you would within any clinical trial you conduct, we expect a high level of honesty,
Note: 5-Day Immersion Course will be November 20-24, 2024
Exam 6: November 16th 2024, 9 AM
integrity, and ethics applied to program tasks.The Honor Code holds that participants are honorable,
Exam 7: (Optional Exam): November 28th 2024, 9 AM trustworthy people and encourages them to behave with integrity in all phases of life. By conforming
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to the Code, participants do their work in an environment conducive to establishing high standards of
personal integrity, professional ethics, and mutual respect.
PRE-PROGRAM ASSIGNMENT
As a basic feature of the Code, participants are placed upon their honor during all examinations, writ- The pre-program assignment is meant to be a self-assessment of your knowledge as you begin the
ten quizzes, computer questions, homework, laboratory reports, and any other work turned in for cred- program. You will do this assignment again at the end of the program to see your progress. Please
it, as required by the instructor. As a reminder of the Honor Code, the participants are asked to write read the article, “Effects of Physical Activity Training in Patients with Alzheimer’s Dementia: Results of
and sign the following pledge on their examination papers: “I have neither given nor received aid on a Pilot RCT Study” (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4401690/) (Holthoff 2015). Then
this examination, nor have I concealed a violation of the Honor Code.” respond to the questions below and submit your answers on the program website. The pre-program
It is always required that ideas and materials obtained from another participant or from any other assignment is due by April 7th at 4pm, and you will submit it at Google Classroom once our
source be acknowledged in one’s work. The latter is particularly important, since material is so freely educational platforms open two weeks before the program starts. In the meantime if you are available
available on the Internet. According to Merriam-Webster online dictionary, to plagiarize is, “To steal and we recommend to work in the assignment and have your answers ready in a Word document.
pass off [the ideas or words of another] as one’s own.” To avoid plagiarism, it is necessary to cite all
sources of both ideas and direct quotations, including those found on the Internet. Pre-Program Assignment
Randomized Controlled Trials (RCTs) are the golden standard for assessing the efficacy of a drug,
Plagiarism medical or surgical procedure, or any behavioral/cognitive intervention. In PPCR, you will learn to
PlagiarismGrading points will be canceled if plagiarism is detected. critically analyze all aspects of RCTs, especially identifying sources of biases and study validity. Indeed
Students should also be aware of Harvard policy on plagiarism (adapted from Harvard Graduate RCTs can provide the highest levels of evidence, and when conducted properly, they have a lower risk
School of Education) - see below at https://extension.harvard.edu/for-students/support-and-servi- of bias than do other types of study designs.
cusing-sources-effectively-and-responsibly/. We regularly run plagiarism detection platforms such as
iThenticate and also tools to detect AI language, if plagiarism is detected, you will loose the points of You will learn, therefore, how to appraise a scientific report for potential sources of bias, and to critically
the forum and other penalties may follow. So please review these two important points below: discuss the findings based on your own assessment of potential bias.

The content from the post should be original. If some text is copied from another source (even if just The following example, by Holthoff et al. (2015) assessed the effects of a program of physical activity
a few words), the source must be acknowledged (author’s name, article, journal and link) and the text training on clinical symptoms, functional abilities and caregiver burden in patients with Alzheimer’s
included between quotation marks (“…”). If non-original content is detected without proper citation, the Disease (AD). Based on what you know now (before taking the course—you do not need to study or
post will not be considered valid for grade. See also Harvard Guide to Use Source at: search for sources to cite in order to respond to these questions, as the goal is for you and us to
https://usingsources.fas.harvard.edu/avoiding-plagiarism assess your knowledge before taking PPCR – this is the only assignment that you are free to answer as
“I do not know” if this reflects your knowledge now), we want you to respond the following questions:
ChatGPT or any other AI tools cannot be used to generate any text for the activities of the program that
include forums, assignments, exams, Group Profect, Mini Review, or Individual Project. Violation of this 1. What is the definition of a bias in a study?
policy will be considered misconduct, like plagiarism, as AI-written text will be not considered as your 2. Can RCTs be biased?
own. We require that you elaborate your own content as this is the base of knowledge and learning. 3. Can you identify any type of biases (such as selection bias, performance bias, detection bias,
attrition bias, and reporting bias) in this study?
Copying and Pasting in the Forum and Plagiarism 4. If you identify sources of biases in question 3, do they affect the final result, and how?
We take the issue of plagiarism very seriously. In the forum, your posts will display a small icon
5. After doing this analysis, would you recommend the use of physical activity training in patients with
indicating whether they are valid or not. If you copied from another source, you need to add quotes
AD? Justify your response.
and cite the source. However, if there is no comment from you using your own words, your post will
not be valid for a grade. Avoid copying and pasting, even though some references from the web may
be useful or comments from your colleagues in other groups may be interesting to share in your group
forum discussion. Remember, the goal of the forum is to develop your critical thinking skills. Also, if
you copy and paste and do not add the source and the quotes, or do not acknowledge your colleague
properly, then your case will be reviewed by our faculty, and you may lose the total forum points for
that week. If this issue is recurrent, administrative measures will be taken. Please note that plagiarism
will be checked electronically several times a week, and past posts can be reassessed for plagiarism if
needed. Speak with us if you have any questions.
Please send all inquiries to our Program Coordinators at 2024coordinator@ppcr.org.

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LECTURE 1 READINGS
1. Case Study 1: There is no free lunch: The cost and benefit of seeking the cure of HIV infection.

2. CHAPTER 1: Nakamura, R., Khawaj, F., Castillo-Saavedra, L., Fregni, F., Freedman, S. D. (2018)
Basics of Clinical Research: Introduction to Clinical Research. In: F. Fregni and B. Illigens (Eds),
Critical Thinking in Clinical Research: Applied Theory And Practice Using Case Studies (p. 3-25).
New York, NY: Oxford University Press.

3. Gower NJ, Barry RJ, Edmunds MR, et al. (2017). Drug Discovery In Ophthalmology: Past Success,
Present Challenges, And Future Opportunities. BMC Ophthalmology. 16.11.
http://bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-016-0188-2

4. Shaikh AT, Ferland L, Hood-Cree R, et al. (2015). Disruptive Innovation Can Prevent The Next
Pandemic. Frontiers in Public Health. 3.215, (pp. 1-5).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4585064/

5. Simunovic M, Coates A, Smith A, et al. (2013). Uptake Of An Innovation In Surgery: Observations

From The Cluster-Randomized Quality Initiative In Rectal Cancer Trial. Can J Surg.
56.8, (pp. 415-421). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3859785/

6. Umscheid CA, Margolis DJ, Grossman CE. (2011). Key Concepts of Clinical Trials: A Narrative Re-
view. Postgrad Med. 123.5, (pp. 194-204). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3272827/

7. Wilson J. (2009). Lessons Learned From The Gene Therapy Trial For Ornithine Transcarbamylase
Deficiency. Molecular Genetics and Metabolism. 96.4, pp. 151-157).
https://www.ncbi.nlm.nih.gov/pubmed/19211285

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