Essential Documents of Clinical Trials

By

Heba RashedClinical data manager of RCENCI

6 Nov. 2013

Essential documents are those documents which individually and collectively permit evaluation of the trial and the quality of the data produced .

Introduction:

• These essential documents serve to demonstrate the compliance of the investigator , sponsor and monitor

with standards of good clinical practice and all regulatory requirements .

Good clinical Practice:

* Adhering to GCP is a thing ,but proving that this has been done is another.* For a trial to be credible in the eyes of authorities , investigators must be able to show that the study is in compliance with GCP guidelines.* This means documenting every study related action .

Maintaining Good Files:

We are going to look at what the investigator /researcher needs to document.But, you also need to be aware that the trial sponsor will also be obliged to keep a file.

The various documents are grouped in three sections:

According to the stage of the trial1) Before the clinical phase of the trial starting.2) During the clinical trial.3) After completion or termination of the trial.

Trial File: • It is good practice to dedicate the

member of the research staff for maintenance and updating of the trial file.

• Filing of essential documents at the investigator / institution and sponsor sites in a timely manner can help in the smooth running of the trial.

• Before the trial :• A)Investigator file: The file will contain:• Signed protocol or research proposal.• Patient information sheet (blank).• Patient consent form (blank).• Advertisement for patient recruitment.• Ethics approval documentation.

A) Investigator file (contin.) :

• CVs of all team involved.• Signature / delegation log.• Clinical trial agreement.• Investigator’s brochure provided by

pharmaceutical sponsor detailing relevant and current scientific information about the investigational product.

A) Investigator file (contin.) :• Normal values for medical / laboratory

procedures and tests.• Lab accreditation certificates.• Instructions and documentation for

handling/transporting of any trial medication and related materials.

A) Investigator file (contin.) :

• Standard operating procedures (SOPs).

• Copies of questionnaires.• Trial initiation report for

sponsored studies.• Master randomization list.

During the trial:• Any protocol amendments.• Any updates to investigator

brochure, CRF, ethics documents.

• Signed patient consent forms.

• Notification of serious adverse events.

During the trial:• Subject identification log:Confidential for researcher only (each patient’s address , date of birth , hospital no).• Subject enrolment log:Documents enrolment of subject by trial number (subject not identified).

During the trial:• Drug dispensing log.• Drug accountability log.( These may hold in pharmaceutical file ).

After completion of the trial:

• Final close-out monitoring reports.• decoding documentation.• Complete subject ID code list.• Drug accountability and returns.• Audit certificate.• Final report to ethics.

Recording Data:• Complete the CRF fully and legibly use a black

pen.• Any correction should be signed and dated with

comment (if necessary).• The corrected data must be visible.• The 1st place you write down data is the source

document (don’t use scraps of paper).

Trial File and Archives:• The investigator should setup study specific files in which all appropriate documentation is filed.

• All study documents should be stored in safe , secure and confidential environment.

• Treat source document as “ gold “ and ensure that they don’t get lost or destroyed.

• Keep for up to 15 years.• Includes medical notes, X-rays, tissue

samples and CRFs.

Archiving: Archiving in clinical research relates to the collection of essential documents , which permit the evaluation of the trial and the quality of data produced for long-term storage.

Archiving:• It is the responsibility of the principle investigator

to arrange for the archiving of research data.• When applicable, negotiate with the commercial

company a payment for the archiving of the site documents as GCP facility.

• Once the study has ended, the investigator is obliged to keep study-related documents for long period of time , often as long as 15 years.

Good clinical practice:• Compliance with ICH-GCP is essential for both

commercial and academic trails.

And Finally: If it is not written down, it didn’t happen!! If it is not documented , it doesn’t exist!!