TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.

1. ESSENTIAL
DOCUMENTS FOR THE
CONDUCT OF A
CLINICAL TRIAL

2. IMPORTANCE OF THE ESSENTIAL DOCUMENTS FOR
THE CONDUCT OF A CLINICAL TRIAL
• Essential documents are important for:
– Evaluation of the conduct of a trial and the quality of data produced
– Successful management of the trial by the investigator, sponsor and monitor
– Validation by regulatory authority(ies) and sponsor’s audits
• Depending on the stage of the trial, essential documents are grouped in three
sections:
– before the start of clinical trial
– during the conduct of the trial
– after the completion or termination of the trial

3. ESSENTIAL DOCUMENTS THAT A MEDICAL WRITER
SHOULD KNOW
Investigator’s brochure
Signed protocols,
amendments (if any) and
sample case report form
(CRF)
Information given to trial
subjects
Financial aspects of the trial Compensation documents
Signed agreements of all
involved parties (Sponsor,
Investigator, Contract
research organization (CRO)
etc.
IRB approval letter & IRB
composition
Curriculum vitae (CV) and/or
relevant documents
evidencing qualifications of
investigator(s) and sub-
investigators
Normal values of
laboratory/technical
procedures included in the
protocol
Medical/laboratory and
technical procedures of
included tests
Sample labels attached to
investigational product
containers
Instructional manuals and
shipping records of
investigational product(s)
and other trial related
material(s)
Decoding procedures for
blinded trials
Master randomization lists,
& Monitoring reports
A medical writer must know about the following essential documents that are required
during a clinical trial

4. ESSENTIAL DOCUMENTS REQUIRED DURING A CLINICAL
TRIAL
Curriculum vitae (CV) of new
investigator(s) and sub-
investigators
Updates on
medical/laboratory/technical
procedures
Documentation and
certificates of investigational
products and trial-related
materials
Signed informed consent
forms, case report form (CRF)
and documentation of CRF
corrections
Source documents and
monitoring visit reports
Relevant notifications on
safety information
Subject screening log,
enrolling log and
identification code list
Relevant communications
other than site visits (letters,
meeting notes etc.)
Interim and annual reports
Record of retained body fluid
and tissue samples (if any)
Signature sheet

5. ESSENTIAL DOCUMENTS REQUIRED AFTER THE
COMPLETION OF A CLINICAL TRIAL
Investigational product(s)
accountability at site
Documentation of
Investigational product(s)
destruction
Completed subject
identification code list
Audit certificate
Final trial close-out
monitoring report
Treatment allocation and
decoding documentation
Final report by investigator to
regulatory authorities
wherever applicable
Clinical study report
Periodic reports on safety (if
encountered) before and
after drug approval

6. Thank you
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