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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