Perspectives in Clinical Research

: 2011  |  Volume : 2  |  Issue : 4  |  Page : 149-

Documents versus facts

Rakesh Parikh 
 Principal Investigator - D Clinarch, India

Correspondence Address:
Rakesh Parikh
Principal Investigator - D Clinarch, B 09, Unnati Tower, Vidhyadhar Nagar, Jaipur - 302 023

How to cite this article:
Parikh R. Documents versus facts.Perspect Clin Res 2011;2:149-149

How to cite this URL:
Parikh R. Documents versus facts. Perspect Clin Res [serial online] 2011 [cited 2022 Dec 3 ];2:149-149
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The recently published paper by Chitra Bargaje on "good documentation practice in clinical research" [1] motivated me to discuss this not often discussed aspect of documents versus facts. I completely agree with the statement - "What is not documented is not done!". But there are situations where certain activities are performed by the subject and they can be documented and endorsed only by the principal investigators.

To give an example, the principal investigator finds a subject eligible for a study reviewing his documents. Though the subject has all documents justifying his eligibility only the principal investigator might find out on history taking,

if the patient has been factually compliant with his advice. The patient may not well be taking treatment advised by the doctor. In this particular case any experienced investigator would not consider the subject for study though he is eligible on documents.

On the other side of the same situation, only an investigator might be able to find on history that the patient is eligible for a study as he has been taking a particular treatment, that has been verified by the investigator, but he may not have sufficient documents to support the same. In such situations, the monitor would accept any additional documents (though they may not have been genuine), but would not accept the endorsement of the investigator regarding the patients eligibility. In countries like India, the majority of source documents comprise prescriptions. An investigator whose motive is just to enroll subjects has the liberty to use his prescription pad for making documents needed for the study. Whereas an investigator, committed to generation of quality data would better document facts and endorse them. Unfortunately having sufficient documents the investigator in prior scenario is able to convince the auditor whereas the endorsement of investigator in later scenario is questioned.

These issues can be resolved only by deciding where does the buck stop. If the sponsor has selected an investigator in whom they have confidence, the investigator should be given the full liberty to document his genuine findings and endorse them. Though such practice might surely lead to misuse of this right, is there anyway a check that prevents investigators from manipulating source documents in the form of prescriptions?

This letter to the editor may not resolve any queries but can surely stimulate a thought process to address this important issue that might be crucial to generate quality data.


1Bargaje C. Good documentation practice in clinical research. Perspect Clin Res 2011;2:59-63.