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No limit on number of clinical trials one investigator can do

Dr Arun Bhatt
Tuesday, December 31, 2019, 08:00 Hrs  [IST]

During EC approval of study member secretary was part of EC review meeting. After EC approval, principal investigator (PI) changed, and member secretary become principal investigator for same study and EC chairman has given approval of change of PI. Is it acceptable?
Vishal Nakrani


This is an issue of conflict of interest.
•    If the member secretary was aware during EC meeting, that he/she is likely become principal investigator, he/she should have abstained from deliberations and voting on the proposal.
•    If the member secretary was not aware that he/she is likely become principal investigator, he/she can become principal investigator for the study.
•    The EC documentation should describe that the member secretary did not have any conflict of interest during the EC meeting.

•    As the member secretary has become the principal investigator, he/she should recuse himself/herself from deliberations and voting whenever there is a discussion on the study for any purpose e.g. deviations, amendments, safety reports, monitoring, etc.

What is minimum training level to be a principal investigator? Is there any guideline for the same?
Dr Swapnil Agarwal

All guidelines/rules (New Drugs and Clinical Trials Rules 2019) recommend that all trial investigators should possess appropriate qualifications, training and experience.
Based on the requirements of investigator undertaking, the investigators should be aware and trained on:
•    New Drugs & Clinical Trial Rules 2019.
•    Indian GCP/ICH GCP.
•    Clinical Trial - Scientific, Ethical, Legal aspects
•    Site SOPs.
•    Protocol.
•    Informed consent process.
•    Investigator’s brochure.
•    Investigational product.
•    Adverse event/SAE - causality relationship, medical management, compensation.
•    Protocol procedure, CRF/eCRF completion.
•    Ethics committee monitoring.
•    Sponsor process - monitoring, audit.
•    Regulatory inspections.
•    Documentation of clinical trial conduct.

Is there any limit for number of clinical trials one investigator can do?  
Dr Vikram Kulkarni

There is no limit on number of clinical trials one investigator can do. As per CDSCO Order of 2 August 2016, EC can decide how many clinical trials an investigator after examining risk and complexity.

Is there any need of DCGI approval for an external device, which will be used during surgery, but is not likely to come in contact with blood vessels?
Dr Sudhir Joshi

As per Indian Medical Device Rules, such a device is like to fall into following category:
•    Surgically invasive medical devices for transient use.
o    (a) Subject to clauses (b) to (g), a surgically invasive medical device intended for transient use shall be assigned to Class B.
o    (b) Subject to clauses (c) to (g), a transient use surgically invasive medical device shall be assigned to Class A, if it is a reusable surgical instrument.
o    (c) A transient use surgically invasive medical device shall be assigned to the same class as the active medical device to which it is intended to be connected.
o    (d) A transient use surgically invasive medical device shall be assigned to Class C, if it is intended for the supply of energy in the form of ionising radiation.
o    (e) A transient use surgically invasive medical device shall be assigned to Class C, if it is intended to have a biological effect or to be wholly or mainly absorbed by the human body.
o    (f) A transient use surgically invasive medical device shall be assigned to Class C, if it is intended for the administration of any medicinal product by means of a delivery system and such administration is done in a manner that is potentially hazardous.
o    (g) A transient use surgically invasive medical device shall be assigned to Class D, if it is intended to be used specifically in direct contact with the central nervous system or for the diagnosis, monitoring or correction of a defect of the heart or of the central circulatory system through direct contact with these parts of the body.
It would be advisable to check the intended use of medical device vis-à-vis above categories and seek opinion of DCGI office about risk and documentation required for


Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com

 

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