Essential documents for clinical trials include documents that demonstrate compliance with good clinical practice standards and regulations. These documents are grouped into three sections: before, during, and after the clinical trial. Key documents include the protocol, patient consent forms, safety reports, data records, and archival documents that must be retained for 15 years. Maintaining organized essential document files is important for evaluating trial conduct and data quality.

1. Essential Documents of
Clinical Trials
By
Heba Rashed
Clinical data manager of RCENCI
6 Nov. 2013

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

3. • 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:

4. * 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:

5. 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 trial
1) Before the clinical phase of the trial starting.
2) During the clinical trial.
3) After completion or termination of the trial.

6. 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.

7. • 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.

8. 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.

9. 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.

10. A) Investigator file (contin.) :
• Standard operating procedures (SOPs).
• Copies of questionnaires.
• Trial initiation report for sponsored
studies.
• Master randomization list.

11. During the trial:
• Any protocol amendments.
• Any updates to
investigator brochure, CRF,
ethics documents.
• Signed patient consent
forms.
• Notification of serious
adverse events.

12. 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).

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

14. 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.

15. 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).

16. 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.

17. 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.

18. 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.

19. 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!!