DOCUMENTATION

Good Clinical Practice Training

National Agency of Drug and Food Control
Jakarta, 11 – 12 June 2008

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 OBJECTIVES

 To identify information related to he trial

 To identify the document used in the clinical trial :
 Source document
 Essential document
 To explain when and where the document should be
available
 To explain what is data quality and data integrity.

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 The need of documents

 As a proof of adequate planning

 Sponsors (and all parties) know what will be and
what should be done.
 Sponsors (and all parties) know the stages of
activities.
 As proof of what have been done at the site.
 Be used to trace back the data or information.

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 DOCUMENTATION (1)

All records, in any form that describes or records :

 the methods,
 the conduct,
 result of a trial
 the factors affecting a trial
 the actions taken

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 DOCUMENTATION (2)

Documentation principle in GCP

 Should be recorded, if it is not recorded  It is

not exist
 All records should be well documented
 Documentation should be easily traced back

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 DOCUMENTATION (2)

1. List of information (group 1) and documents

(group 2)  10 minutes.
2. Make sure that each item list has been put in
the right place (group 3)  10 minutes

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 DOCUMENTATION (2)

Type of Documents :
 Source document

 Essential document

Those documents should be well documented and

archived

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 Source document

Source document  original data, documents,

records, e.g : medical records, laboratory result, X
– rays, correspondence, note, subject’s dairy.

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 Essential Document

 Essential documents  include : source

documents, protocol, CRF , Informed consent,
etc.
 Essential document :
 Which are audited by independent body or inspected
by the regulatory.
 To be used to evaluate the quality of the
performance of the trial conduct.

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 Essential Document

 To be used to assess the compliance to the approved

protocol.
 To be used to assess the quality and integrity of data
produced.
 Should be filed in a timely manner time.

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 DOCUMENTATION (3)

About documentation

1. Records inventory / Site Master File

2. Subject’s record

3. Human subject protection documentation

4. Protocol

5. Drug accountability

6. Archiving and confidentially

7. SOP

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 1. Site Master File

 What is Site Master File (SMF) or Records Inventory

 To simplify finding the documents needed.
 What kind of documents that could be in the SMF
 Documents in the SMF e.g :
 Approvals
 CV
 Signature sheet log
 Contracts
 Informed Consent
 Logs

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 2. Subject’s record

 All subject records or information that related to the trial

 As human subject protection
 There are many information that should be covered and
recorded
 Some examples :
 Screening Log
 Enrollment Log
 Identification Code List
 CRF
 Dug dispensing log

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 Exercise (2)

 Developing :
 Screening Log.
 Enrollment Log.

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 Subject information in the Screening Log
(should cover all subjects screened) e.g :
 Subject initial
 Subject number
 Date of subject’s consent
 Date of screening
 Screen failure

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 Subject information in the Enrollment Log
(should contain at least the same subject as in
the screening log, and it can be combined with
the screening log) e.g :
 Subject initial
 Subject id / randomization number
 Date of randomization
 Date of completion
 Date of withdrawal / drop out
 Reason for withdrawal / drop out

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 Subject information in the identification code List
(include all subject enrolled and should be kept
confidentially by the investigator) e.g :
 Subject initial
 Subject id
 Subject’s name and address
 Date of birth
 Date of subject’s consent
 Date of subject screened
 Date of randomization

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 Exercise (3)

Documents that give

Impact to subject’s safety

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 3. Document for human subject protection

Documents  that could affect directly and or

indirectly the safety of the subjects, e.g :
 Approvals,
 CRF
 Informed consent
 IP (test drug) accountability

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 4. Protocol

 Written procedure on how to conduct a trial

 Consider the completeness of the protocol :
 Administrative issue
 Component
 Scientific issue
 Ethical issue
 Compliance

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 5. Drug Accountability

Trial drugs should accounted for in each activity :

• Receipt card
• Drug dispensing log
• Trial drug log

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 6. Archiving / Filing

What are the important aspects :

• Space / room
• Access
• Locked
• Secure
• How long should be kept

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 7. Standard Operating Procedure

Beneficence to develop SOP :

• Knowing what will do
• Identifying activities
• Having consistency
• Knowing who will responsible in each activity

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 Documentation (4)

Documents that should be available :

• Before the trial
• During the trial
• After the trial
 Need to be monitored by the sponsor / CRO
 Could be inspected before, during or after the trial

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 Exercise (4)

DOCUMENTS DURING THE

TRIAL

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 Documentation (5)

Availability of clinical trial documents :

• Documents at the investigator site, or
• Documents at the sponsor site, or
• Documents at both site

What kind of document that absolutely should be at

the investigator site.

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 Documentation (6)

What about documents :

• Quality
• Integrity
• Could be verified
• Should be easy to be traced back
• To be used as evidence and proof :
 For the compliance of parties involved to the GCP
standard.
 What kind of treatment received by the subject.

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 1. Quality Data

Quality data :
• Accurate
• Legible
• Complete and contemporaneous (recorded at the
time activity occurred)
• Original

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 2. Data Intergrity

Quality data :
• Credible
• Internal Consistent
• Independent verifiable (Corroborated)

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Summary

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