ESSENTIAL DOCUMENTS FOR
THE CONDUCT OF A CLINICAL TRIAL
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
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
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
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 reportPeriodic reports on safety (if
encountered) before and after drug approval
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