Essential documents are those documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. Essential documents serve to demonstrate compliance with the standards of Good Clinical Practice (GCP) and with all applicable regulatory requirements. These document files may be audited by the sponsor and regulatory authorities to confirm the validity of the clinical research conduct and integrity of the data. The essential documents for clinical trials are the following: Investigator's Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form. Essential documents are commonly referred to as regulatory documents. ICH GCP guidance defines essential documents as “those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced. The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it happened. It should enable an independent observer to reconfirm the data. Documentation should be such that it is able to provide audit trail to permit investigation if and when required. Siro Clinical Research Institute Siro Clinpharm initiative www.siroinstitute.com Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing. #Pharmacovigilance #CDM #data #Clinicalresearch, #regulatoryaffairs, #medicalcoding, #clinicalSAS #management #health #comment #pune #clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing #clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch # #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing #pharmacovigilance #statistics #biostatistician #opportunity #interview #biostatistics #statisticalprogramming #team #fresher #project #students #development #projects #work #leaders #people #learning #culture #productivity #leader #event #clinicalresearch #clinicaloperations #clinicaldatamanagement #cdm #clinicalresearchassociate #clinicalresearchcoordinator #pharmacovigilance ,#medicalcoders ,#sas ,#SASprogrammers #Biosatisticians, #Clinicaltrialdesign, #eTMF #lifescience #medicaldevices,#scdmindia,#societyforclinicaldata #lifesciencemanagement,#pharmaceuticals,#medicalwriting #clinicalresearchinstitute #CRA #CRC #Databasedesign #pharmacovigilanceindia #CTA #pharmacist #EDC , #GCP #pharmacovigilance #clinicalresearch #quality #clinicalresearchassociate #clinicalresearchcoordinator #clinicalresearchjobs #clinicaltrialmanagement #clinicaltrials #clinicaltraining #pharm

1. Essential Documents
Presented by:
Vinay Kasare
Dr. Geetu Mohan
Manali Patil

2. Content
• Introduction
• Importance of Essential Documents
• Trial Master File
• Essential Documents: Before the trail ,During the trial, After the trial
• References

3. Introduction
• Essential documents are those documents which individually and
collectively permit evaluation of the conduct of a study and the
quality of the data produced.
• In any work or process documents that are needed before initiation,
between or generally end of the process just like in a clinical trial
those “ Documents which permit evaluation of the conduct of a trial
and the quality of the data produced.

4. Importance of Essential Documents
• 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 and sponsor’s audits.

5. Classification
Depending on the stage of the trial, essential documents are group in
three sections:
During the
conduct of
the trial
Before the start
of clinical trial
After the
completion
or
termination
of the trial

6. Trial Master File
• Guideline E6 states that TMF should be established at the beginning
of the trial, both the investigator/institution site and the sponsor office
• A final close-out of the trial only be done when the monitor has
reviewed both the investigator/institutional and sponsor file and
confirm that all necessary documents are in the appropriate file.

7. Before the Trial(1/2)
• Investigator Brochure
• Sign protocols ,amendments (if any) and sample case report form
(CRF)
• Patient information Sheet
• Patent consent form
• Ethics approval documents
• CV’s of all team members

8. Before the Trial(2/2)
• Signature and Delegation log
• Clinical trail agenda
• Normal values for medical/laboratory procedures and test
• Instruction and documentation for handling/transporting of any trial
medication and related material
• Standard operating procedure
• Master randomization list
• Case record form

9. During the Trial(1/2)
• Any protocol Amendments
• Any updates in IB
• Dated documented approval/favorable opinion of IRB/IEC of the
following.
• Notification of SAE/AE
• Interim or annual report to IRB/IEC and authority.

10. During the Trial(2/2)
• Subject identification and enrolment log
• Instructions for Handling of IP and trial related material
• Signature sheet

11. After completion of the trial
• IP accountability at site
• Documentation of IP destruction
• Audit certificate
• Final trial close-out monitoring report
• Treatment allocation and decoding documentation
• Final report by investigator to IRB/IEC where required, and where
applicable to the regulatory authorities
• Clinical study report

12. References
• Essential documents for the conduct of a clinical trial: ICH E6 (R2)
Good clinical practice