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/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.

Source Data Examples

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

Corrections to Source Data

[the reason for the change must either be apparent or an explanation provided]

Four elements must be visible each time an original data value is changed:

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.

ICFDocument 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 Tips1. 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-consented3. 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

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 the ICF

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 Documentation – Top Tips

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 OPERATIONA statement from the EC that it operates according to

local/national/regional guidelines and GCP

3. EC COMPOSITIONA 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 ECIf 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 RECORDProvides 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 LOGA 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 LISTList 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 REPORTDocuments a substantive contact between site staff and

sponsor Kept by Sponsor (can be forwarded to the Investigator,

depends on the content).

IP AccountabilityDocument 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!

What is not written ……………………………………………………...is considered as not done

Write what you do………………………….

…………………………do what is written