Tool Summary Sheet

Tool: Task Distribution Checklist

Purpose: To identify who (at a group level) will be responsible for each of the various tasks
associated with planning, executing, monitoring, analyzing, reporting, and
archiving a clinical research study
Audience/User: Lead Investigators, IND/IDE Holders (when applicable), and all others responsible
for any of the delineated tasks on the list
Details: This document identifies which group will be conducting each of the various study
tasks but is not intended to be a legal transfer of sponsor obligations. As such,
when an IND/IDE is obtained, the IND/IDE sponsor retains overall regulatory
obligations for the study.
The objective of this document is to ensure that all potential study responsibilities
are considered and clearly assigned.
Best Practice  This document should be prepared early in a study to ensure that all
Recommendations: responsibilities are clearly established.
 This tool can be edited to suit the needs and requirements of the study.
You can indicate “Not applicable” or remove rows at your discretion.
There are additional blank rows included for your convenience; add other
responsibilities that may be important and/or unique to your study in these
rows.
 All parties noted in the checklist should agree on the delineation of
responsibilities and receive a copy of the completed document.
 This is not intended to replace the Delegation of Responsibilities Log,
which differentiates site specific clinical responsibilities.
 Changes to the grid should be documented and the updated version
should be made available to all responsible parties.
 If you are not using the services of CROMS (Rho), you can replace that
column heading with the designation of the relevant Data Coordinating
Center.
 Below are suggestions for completing the tables. Use the strategy that
works best for your study.
Insert “X” into cells in a row when one group is solely responsible for a
task. In some cases, when multiple groups share some responsibilities, it
may be helpful to use “Lead” to indicate the group with primary
responsibility for the task and “X” for others who also play a role in that
task. You can use additional terms, if useful, to clarify the roles of other
groups. If the terms are necessarily abbreviated or not intuitive, add the
abbreviation to the “Abbreviations and Terms” table at the end of the
document.
For documents being developed, use “Develop” for the initial author. If the
author is also the person making any updates to the master document,
then it is not necessary to have a separate “Update” delineation. It is
assumed that the authoring group and the approving group will also have

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“Review” responsibilities, so you don’t need to specify “Review” for those

groups. Use “Review” for other groups who have review responsibilities.

Use “Update” if a party other than the author is responsible for updating
the document. (It is best to avoid the term “Revise” because the
abbreviation will be difficult to differentiate from “Review.”) Use “Approve”
for the group with the ultimate approval authority. This is not intended to
be the IRB, for example, in the case of a protocol, but rather the study
team group that approves the document prior to delivery to the IRB. You
may need to abbreviate for a group that has more than one responsibility
(e.g., Upd/App).

You may also choose to be more specific about the role responsible for a
given task (e.g., Study Coordinator).

Here are a few example items:

CROMS
PI/Sponsor OCTOM (Rho) Other, Specify
Develop, review,
update, and NIDCR Clinical
approve Develop Director
protocol Develop Review Lead Approve
Provide expert
support for
protocol
development
(list Statistics
clinical/scientific, Regulatory
Clinical/scientific
statistical, Safety
regulatory, Ops
safety, &
operational
(ops)
separately)
Oversee central
laboratory for X
patient samples
Conduct internal
team meetings X X
and trainings*
Design, review, Approve Review Develop Site Study
update, and Coordinator
approve CRFs Committee will
Review
Package/label Oversee Pharmaceutical
study drug Distribution

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CROMS
PI/Sponsor OCTOM (Rho) Other, Specify
Services--Lead
Enter data onto Site Study
CRFs Coordinator
*Because both groups independently lead their own internal meetings and
because neither group is considered to be the overall owner of this task, both
are marked with an X.

 <> indicates a field that should be updated with study specific information.
 Establish a plan for approval and update of this checklist. Edit the
“Approval and Update Plan” portion of this document as needed, based on
the plan that is established. If you choose to collect signatures, a
signature page has been included in the tool.
 Clinical research operations and management tasks must be conducted to
ensure human subject safety, data integrity, and Good Clinical Practice
(GCP).

Tool Revision History:

Version
Number Date Summary of Revisions Made:
Version 1.0 27OCT2010 Approved version
Version 2.0 17JAN2011 Integration of OCTOM comments and
update to ensure IRB responsibilities
clarified
Version 3.0 14NOV2011 Added Unanticipated Problem Reporting
section; revised ICF references; added /IDE
to IND references

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Protocol: <Specify Protocol Abbreviated Name> Task Distribution Checklist

Task Distribution Checklist

Protocol Title:

Protocol Number:

IND/IDE Sponsor:

Principal Investigator Name:

Funding Sponsor:

Grant PI:

Study PI:

Clinical Site PI(s):

Initial Version Date:

Revision History:
Revision Date: Summary of Revisions Made

This document identifies which group will be conducting each of the various study tasks but is not
intended to be a legal transfer of sponsor obligations. As such, when an IND/IDE is obtained, the
IND/IDE sponsor retains overall regulatory obligations for the study.
Instructions: The distribution of tasks for operational conduct of this study is assigned below. For items
in which responsibility is shared, mark all relevant parties (see Tool Summary Sheet for further details).
If “Other” is true, please specify the name of the responsible party/group. Additional lines have been
included to allow for study specific customization. Please enter any abbreviations used into the
Abbreviations and Terms table at the end of the document; some terminology has been pre-defined
therein.

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Protocol: <Specify Protocol Abbreviated Name> Task Distribution Checklist

Study Management Not PI/Sponsor OCTOM CROMS Other, Specify

Applicable (Rho)
Provide overall program
management and support (e.g.,
1 establishment of project
plans/timelines, communication plan,
execution strategies)
Provide administrative support for
2 meetings (e.g., agendas, minutes,
scheduling, dial-in numbers)
Participate in teleconferences (team
3
meetings)
4 Plan/attend face to face meetings
Conduct internal team meetings and
5
trainings
Provide status reports (accrual,
6
SAEs, AEs, PDs, timelines, etc.)
Oversee drug manufacturing
7
facilities
8 Oversee study product supplier
Oversee study product
9 packaging/labelling/distribution
center
Oversee central laboratory for
10
patient samples
Oversee contract research
11
organization
12 Oversee clinical supply vendor
13 Oversee translation vendor
14 Oversee archival vendor
Initiate the study in ClinicalTrials.gov
15 and provide updates on study
progress
Provide final study results to
16
ClinicalTrials.gov
Provide study status reports and
17 updates to OCTOM for CTMS
reporting

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Study Management Not PI/Sponsor OCTOM CROMS Other, Specify

Applicable (Rho)
18 Manage site payments
Manage IRB submissions, contacts,
19
follow-up, and annual updates
20

IND/IDE (Regulatory) Services Not PI/Sponsor OCTOM CROMS Other, Specify

Applicable (Rho)
Develop, review, update, and
1
approve Investigator Brochure
Develop, review, update, and
2 approve annual updates to
Investigator Brochure
Develop, review, update, and
3
approve IND/IDE
Submit and maintain IND/IDE
4 (serve as regulatory contact for
IND/IDE)
Develop, review, update, and
5 approve Annual Reports for
IND/IDE
6 Distribute Annual Reports
Sign materials being sent to the
7
FDA
Submit documents to FDA: Annual
8 Report, Safety Report,
correspondence, other serials, etc.
9
10

Not CROMS
Study Materials PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
Develop, review, update, and
1
approve study protocol
Provide expert support for protocol
development (list clinical/scientific,
2
statistical, regulatory, safety, &
operational (ops) separately)

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Not CROMS
Study Materials PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
Develop, review, update, and
3
approve protocol amendments
Distribute protocol to sites (may be
4
in electronic format)
Provide/develop, review, update,
5 and approve consent document
templates
Provide/develop, review, update,
6
and approve assent templates
Distribute consent template to sites
7
(may be in electronic format)
Review and approve consent /
8 assent customization from other
clinical sites
Develop, review, update, and
approve Study Manual of
9
Procedures (MOP) or Study
Specific SOPs
Assemble/distribute study MOP or
10
Study SOPs to site(s)
Provide Investigator Brochure to
11
site(s) (may be in electronic format)
Develop, review, and approve study
12 advertisements and/or patient
handouts
13 Package/label study drug
Manage provision of study drug to
14
subjects at the site
Authorize study drug and materials
for destruction/return to sponsor or
15
inform subjects to discard study
drug
16 Provide study aids
Prepare Essential Documents
17
Binder
Establish and Maintain Trial Master
18
File
19
20

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Protocol: <Specify Protocol Abbreviated Name> Task Distribution Checklist

Not CROMS
Study Initiation/Activation PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
1 Conduct feasibility assessment
2 Conduct PK feasibility assessment
Develop, review, update, and
3
approve subject recruitment plan
Conduct launch meeting with full
4
study team
5 Conduct ongoing project training
Collect/conduct initial review of
6
consent documents
Collect/conduct initial review of
7
essential study documents
Collect financial disclosure
8
information
9 Schedule the initiation visits
10 Conduct site initiation visits
11 Participate in site initiation visits
Ensure follow-up on action items
12 and additional training needs
identified during initiation visits
Approve sites for activation (to
13
begin enrollment)
14
15

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Not CROMS
Site Management PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
Document and communicate study
1
decisions to project team
Maintain log of questions regarding
study logistics or protocol/CRF
2
details and communicate responses
to project team on an ongoing basis
Participate in scheduled
conference/ one-on-one calls to
3 discuss study progress (e.g.,
CROMS study coordinator to site
study coordinator or PI)
4
5

Not CROMS
On-Site Monitoring PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
Conduct on-site monitoring and
1
close out visits
Review and verify data recorded on
2
CRFs against source documents
Obtain corrections to CRFs, resolve
3
queries
4 Review drug records
Verify compliance with the protocol
5
and regulations
Assess and maintain training of site
6
personnel
Provide written reports for all
7
monitoring visits
8
9

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Protocol: <Specify Protocol Abbreviated Name> Task Distribution Checklist

Not CROMS
Randomization PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
Develop, review, update, and
1
approve randomization plan
2 Develop mock randomization tables
Develop and validate
enrollment/randomization
3
process/system, including quality
control measures
Approve randomization
4
system/process
Deploy and maintain randomization
5
system/process
Provide support for randomization
6 system/process, including
unmasking
Authorize randomization code
7
breaks
8
9

Data Management and Database Not CROMS

PI/Sponsor OCTOM Other, Specify
Programming Applicable (Rho)
Design, review, update, and
1
approve CRFs
Develop CRF completion
2
instructions
3 Print CRFs
4 Store/distribute CRFs
Develop, review, update, and
5
approve Data Management Plan
Provide document control of CRFs
6
(log, track, archive)
Design database, edit check
7
specifications, and perform testing
Prepare source document
8
templates
9 Maintain source documents

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Data Management and Database Not CROMS

PI/Sponsor OCTOM Other, Specify
Programming Applicable (Rho)
10 Enter data onto CRFs
Perform data cleaning and query
11
generation
Update query responses in
12
database
Conduct and approve medical
13 coding of adverse events and
concomitant meds
14 Sign CRFs
Perform ongoing and final database
15
audits
16 Lock database
17
18

Not CROMS
Lab Specimen Management PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
Develop, review, update, and
1 approve specimen tracking system
specifications/plan
Create and validate system for
2 tracking specimens, per
specifications noted above
Develop specimen tracking system
3
user instructions
Design system, edit check
4
specifications, and perform testing
5 Print specimen labels
6 Distribute specimen labels to sites
Perform data cleaning and query
7 generation within specimen tracking
system
Update query responses in specimen
8
tracking system database
Provide user support for specimen
9
tracking system
10

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Not CROMS
Lab Specimen Management PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
11
12

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Biostatistics and Statistical Not CROMS

PI/Sponsor OCTOM Other, Specify
Programming Applicable (Rho)
Develop, review, update, and
1 approve statistical analysis plan
(SAP)
Develop mock displays for final
2
report
Develop analysis database
3
specifications
Create and validate analysis
4
datasets
Develop, review, update, and
5 approve annual report displays and
analyses
Develop, review, update, and
6 approve interim analyses, per
protocol
Develop, review, update, and
approve DSMB and other Safety
7
Oversight analyses, data displays
and reports
Develop, review, update, and
8 approve final, per-protocol analyses
and data displays
Develop, review, update, and
9
approve statistical report
Provide analysis database and
10
supporting documentation to PI
11
12

Not CROMS
Unanticipated Problem (UP) Reporting PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
Collect Unanticipated Problem data
1
and report UPs to the IRB
Report UPs to Program Official /
2 Clinical Director / OCTOM, as
applicable
3
4

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Not CROMS
Safety Oversight PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
Organize and plan the Safety
1
Oversight kick-off meeting
Attend Safety Oversight kick-off
2
meeting via teleconference
3 Draft the Safety Oversight Charter
4 Prepare for Safety Oversight meeting
5 Attend DSMB meeting
6 Record DSMB meeting minutes
Develop, review, update, and approve
7
Safety Analysis Plan
Provide ongoing Safety Oversight
8
support
9 Provide ongoing SAE support
10
11

Not CROMS
SAE Management/Reporting PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
1 Prepare Safety Management Plan
Receive initial SAE information from
2
sites
Obtain follow-up information
3
regarding SAE/SAE closure from site
Prepare narrative template for
4
Regulatory Safety Reports
Write SAE narratives for Regulatory
5
Safety Reports
6 Maintain SAE database
7 Maintain SAE tracking database
Prepare periodic line listings (blinded
8
and unblinded)
9 Distribute periodic line listings
Perform unblinding of SAEs for
10
expedited/SUSAR reporting

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Not CROMS
SAE Management/Reporting PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
11 Report SAEs to IRB
12 Distribute SAE reports to IRB
13 Prepare Dear Doctor Letters
14 Distribute Dear Doctor Letters
Conduct SAE database and AE
15
clinical database reconciliation
Conduct SAE database and SAE
16
tracking log reconciliation
Issue queries resulting from
17
reconciliation
Manage query resolution resulting
18
from reconciliation
19
20

Not CROMS
Medical Monitoring PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
Provide full medical
1
monitoring/management services
Provide scheduled medical
2
monitoring backup (Rho employee)
3 Provide CRA support
4 Provide site support
5
6

Not CROMS
Scientific/Medical Writing PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
Develop, review, update, and
1
approve Clinical Study Report
Write medical narratives for the
2
Clinical Study Report

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Not CROMS
Scientific/Medical Writing PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
Develop, review, update, and
approve manuscripts and
3
presentations for submission to
journals and conferences
4
5

Not CROMS
Site Monitoring/Quality Assurance PI/Sponsor OCTOM Other, Specify
Applicable (Rho)
Conduct investigative site monitoring
1
visits
Conduct audit of the Investigator/site
2
files in the trial master file
3 Conduct audit of Rho facility
Ensure Investigators have completed
4
GCP training
Conduct audit of Clinical Study
5
Report
Develop, review, update, and
6 approve study specific SOPs, guides,
and policies
7
8

Study Documents Archiving and Not CROMS

PI/Sponsor OCTOM Other, Specify
Disposition Applicable (Rho)
Archive all electronic and paper
1
documentation
Send essential documents (a.k.a.
2
Trial Master File) to sponsor
3
4

Abbreviations and Terms

Approve Responsible for approval prior to, when required, delivering to an external
regulatory body such as the IRB or FDA

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Protocol: <Specify Protocol Abbreviated Name> Task Distribution Checklist

Develop Responsible for initial development

Lead Responsible for ensuring that the task is completed
Review Responsible for reviewing a document. Not necessary to indicate for those
marked with “Develop” or “Approve” responsibilities
Operational (Ops) Activities associated with practical implementation of a protocol.
Update Responsible for updating an item, if other than the individual with “Develop”
responsibilities
X Responsible for some or all of the components of the specified activity.

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Protocol: <Specify Protocol Abbreviated Name> Task Distribution Checklist

Approval and Update Plan

This checklist will be approved by <name of party or parties> via signature.

This document will be maintained by <group>, any changes to responsibilities designated herein will be
clearly communicated to relevant parties by <group> in a timely manner. An updated version of the
document will be distributed <frequency> by <group>. Changes from one version to the next will be
outlined in the “Revision History” table by <group>. For updated versions that are distributed,
signatures will only be collected from groups for which a responsibility has changed since the previous
version.

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Protocol: <Specify Protocol Abbreviated Name> Task Distribution Checklist

SIGNATURE PAGE

Instructions: Because groups tend to be geographically dispersed, a separate signature page will be
distributed to and collected from each separate group.

Group Title: _________________________________________

I acknowledge receipt and review of this document.

_______________________________________ ___________
<Name and Title of Signatory> Date

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