Good Documentation

Practices
We always think that the purpose of clinical research is
to help the patients who are subjects in the clinical
trial; the real purpose of clinical research is to
provide data to prove that a drug, biologic, or
treatment is safe and efficacious, and to therefore
benefit patients in the future. If a current subject
receives benefit from the trial, it will be bonus.
Clinical trials is an organized research, conducted on human beings to
investigate the safety and efficacy of a drug.

What is GCP: International ethical and scientific quality standard for :

 designing

 conducting

 recording

 reporting

trials that involves the participation of human subjects

Why GCP:
 Legal Requirement

 Protects the rights, integrity & confidentiality of research subjects

 Provides assurance that the data & results are credible & accurate

 Global Acceptance of the data

 Source Data Examples

Source data/document refers to the original documents (or

their verified and certified copies) necessary for evaluation of
the Clinical Trial.

Source document include Study Subject’s files, recordings

from automated instruments, tracings, X-Ray and other films,
laboratory notes, photographic negatives, magnetic media,
hospital records, clinical and office charts, Subject’s diaries,
evaluation checklists, and pharmacy dispensing records.

All entries in worksheets or patient files should have the date

and initials of person making the entry.
 Source Data Examples

All the records of a patient should be filed in one file or

together. If the patient is referred to another
department/hospital, all the relevant records should be
included in the source document.
Start and stop date for all adverse event(s) and corrective
medication(s) should be clearly stated in the patient’s source
document.

Environmental control (protection from fire, flood, termite etc.)

must be maintained throughout the duration of archival.
 Corrections to Source
Data
Four elements must be visible each time an
original data value is changed:

(1) The old value

(2) The new value
(3) The date of the change
(4) By whom the change was made.

[the reason for the change must either be apparent or

an explanation provided]
 Regardless of whether source data and records are
paper-based or electronic, they must be legible, accurate,
secure, and indicate by whom, when, and why they were
created or modified. For paper records, these requirements
are part of Good Documentation Practices.

Examples of a Good Documentation Practices that is

suitable for use in written data and records generated in
conjunction with clinical research:
 Entering Data:

1 Handwritten entries on documents must be made using permanent

(indelible) blue or black ink. Erasable ink, non-waterproof ink, and pencil are
not permitted

2 Correction fluid and correction tape are not allowed on documents.

3 The date and time hand written on a document will be the current date
and time at the location where the handwritten entry is made

4 The preferred format for the handwritten date on documents is the format:
2 digit day, 3 character month, 4 digit year. The format 2 digit month, 2 digit
day, and 2 digit year is also acceptable in circumstances where the date will
not be confused

5 The handwritten time on documents will include a.m. or p.m.

6 Document entries must be made immediately after completion of a step or

a process
 7 Signature entries shall be consistent with the signature
recorded in the study signature log.
8 Initial entries shall be consistent with the initials recorded
in the study signature log.
9 No one shall enter a signature or initials for someone else.
10 All entries must be made directly onto the official record
or document. The use of scratch paper, post-it notes, or
unofficial notes to record data is not permitted.
11 All documents requiring review and approval signatures
shall contain the original handwritten signature and date
signed. Signatures made by rubber stamps, pre-printed
labels, photocopy, or fax are not permitted.
 Editing Data

1 When a correction is needed, draw a single line through

the entire incorrect entry, enter the correct information and
initial and date the correction. When the reasons for the
correction is not obvious, place an asterisk or number next
to the incorrect entry and explain the correction at the
bottom of the page, identified by the asterisk or
corresponding number.
Note: Write-overs are not permitted.

2 All missing entries must be explained. If an entry is not

completed at the time the function is performed, place an
asterisk or number at the point of the missing entry and at
the bottom of the page explaining the missing entry. Initial
and date the entry.
3 To ensure that inappropriate entries are not made at a later
date, a line shall be drawn on all blank spaces if the reason
for that blank space is not apparent. If the blank space is left
because an entry is not applicable, “NA” may be entered.

4 Backdating (entering a date on a day after the entry was

made or the task was performed) is not permitted.

5 Postdating (entering a date in the future) is not permitted.

6 When a document requires an entry upon completion of an

activity and the activity was performed but not documented,
an explanation (by the performer of the activity) of why there
was an omission must be included, signed, and dated.
ICF
Document for voluntary written consent of a
subject’s willingness to participate in a particular
study.

Contain information about the trial including an

explanation of its status as research, its
objectives, potential benefits, risks and
inconveniences, alternative treatment that may
be available and of the subject’s rights and
responsibilities
 ICF Documentation – Top Tips
1. COMPLETION OF ICF
A version date and a version number should identify each ICD and its all subsequent
amendments.
Translation of ICD in vernacular languages must be approved by ERB.
Only the ERB approved version of ICD should be administered to the patients.
ICD should be obtained before non-routine screening procedures are performed and/or
before any change in the subject's current medical therapy is made for the purpose of the
clinical trial.
Investigator or designee should personally obtain the ICD from the subject.
Subject should receive a copy of the signed ICD.
2. SITUATIONS FOR RE-CONSENT
Amendments to the ICF (normally resulting from Protocol amendments) may result in
ongoing subjects having to be re-consented
3. TRANSLATION
Ensure that the ICF is translated into all necessary local languages
The following elements need to be a part of the
ICF process:
 As the source of patient recruitment is referrals, the referring
doctor/ hospital should be mentioned
 Patient queries during ICF process
 PI/ consenting physician replies to the above
 Patient meets the initial eligibility criteria
 The name of the trial in the ICF narrative should be mentioned.
 Whether the copy of ICF given to the subject
 Willingness of the subject for the trial
 Time to Subject to sign the ICF
 Who took the consent & when
 Version number of ICF & translation used
 Trial Involves research
 Reasonable foreseeable risks or inconvenience to the subject
 Duration of the trial
 Subject participation is voluntary
Common problems with the ICF
Fail to include all require elements of ICH GCP
Fail to explain scientific/ technical language
Incorrect version of the ICF used
ICF not administered in the language the subject best
understands
Amendment not approved by ethics committee and
used for taking consent
Copy of ICF not given to subject
Investigator dates, for the subject
Common problems with ICF
Investigator signs but does not date the ICF
Thumb impression of subject present along with a date
Relationship of the LAR to the subject not mentioned (when
required in the consent form)
Not signed by the person who actually conducted the process
Minor signs consent form with no signature of parent/ LAR
Subject does not write date or writes incorrect date
Subject signs and/or dates using pencil
Sign of witness taken unnecessarily even if subject/ LAR is
literate and consented
EC Approval
Document to grant permission for the conduct of a
trial at individual investigator site
EC approval should include the name and version(s) of
the documents reviewed for granting approval.
EC approval must contain signature, date and seal of
chairperson; list of voting members; and list of members
who were absent.
EC approval must contain the duration of approval.
EC approval must be obtained prior to initiating a clinical
trial at any site.
EC Documen t ati on –Top Tip s

1. EC APPROVAL LETTER

 Headed paper
 Signed & dated by Chairman of IEC (or other authorized
individual, according to EC written procedures)
 Protocol Number, Title & Version/Date
 Date of IEC Meeting
 Unconditional Approval (Favorable opinion)
 Documents Reviewed
 Investigator’s CV
 Investigator’s Brochure (IB) / Supplemental IB
 Safety Reports – issued since cut off date of IB
 Protocol –Any Protocol Amendments – Version/Date
 Informed Consent Form (ICF) Version/Date (e.g.
English/Translated Versions)
 Advertising material – Version/Date
 Subject Card
 EC Documentation – Top Tips

2. EC OPERATION
A statement from the EC that it operates according to
local/national/regional guidelines and GCP

3. EC COMPOSITION
A list of EC members / qualifications (composition) where country
regulations permit

4. CONTINUING EC APPROVAL / ANNUAL STUDY PROGRESS

REPORT
Check / monitor EC approval has not expired (re-application may
be necessary) and check that the Investigator provides the EC with
a Progress Report (according to IEC requested frequency – but at
least annually)

5. INVESTIGATOR MEMBER OF EC
If the Investigator is a member of the EC – a statement is required
to confirm that the investigator did not vote
 Essential Documents
Form # 1: SITE VISIT RECORD
 Provides documented evidence that the monitor had direct contact with
the site staff and confirms that the site had been visited by the monitor on
the visit days stated on the monitoring reports.
 Kept by the Investigator and Sponsor

Form # 2: SITE STAFF SIGNATURE SHEET (SSSS)

 It is used to record all site staff who have a critical effect on the conduct of
the study and to whom the investigator has delegated significant study
related duties.
 Kept by the Investigator and Sponsor

Form # 3: SUBJECT SCREENING & ENROLLMENT LOG

 A screening log demonstrates that no bias was used in selection of
subjects for a study.
 List of all subjects enrolled on a clinical study. It is used by the investigator
to document the chronological enrolment of subjects by study subject
number.
 Kept by the Investigator and Sponsor
Essential Documents

Form # 4: SUBJECT IDENTIFICATION CODE LIST

List used by the investigator/institution to allow the
identification of any clinical study subject from their study
subject number.
Kept by the Investigator only.

Form # 5: CONTACT REPORT

Documents a substantive contact between site staff and
sponsor
Kept by Sponsor (can be forwarded to the Investigator,
depends on the content).
 IP Accountability
Document to provide complete accountability of investigational product
including receipt, dispensing, returned, destruction etc. at all levels
(sponsor, investigator and patient level).

Investigation product(s) should be stored at required temperature

conditions.

Temperature logs should be maintained on a daily basis.

Investigational product should be kept under proper access control.

Any deviation in storage condition should be reported appropriately and the

material should be inspected for potency (if required)

Any loss/damage/breakage etc. should be properly documented.

 Crux of GCP!

Write what you do………………………….

…………………………do what is written

What is not written ………………………………

……………………...is considered as not done