How do define the role of a clinician, member secretary and also others in the EC?

Roles and responsibilities of the EC members are:

• Main responsibilities are protection of rights, safety, rights and well being of the research participants.
• Review and  discuss research protocol  submitted for approval
• Review risk benefit of research protocol
• Review progress reports and monitor ongoing studies.
• Review and monitor safety data/updates/SAEs and recommend appropriate action(s).
• Maintain confidentiality of the documents and deliberations of the HEC meetings.
• Declare conflict of interest, if any.

Member secretary is responsible for scheduling the meetings, describing the agenda, documenting minutes and decisions, and ensuring that the function of the committee is conducted as per EC SOPs.

What are the supporting documents to be attached for proving that the members in committee are conversant with the GCP guidelines?

The members should be conversant with the provisions of clinical trials - Schedule Y, GCP guidelines for clinical trials in India and other regulatory requirements - to safeguard the rights, safety and well-being of the trial subjects.

Documents - e.g. training certificate along with the details of GCP training programme attended would be required to prove that the members of the committee are conversant with above requirements.

Looking at registration letters issued by CDSCO to Independent ECs (IECs), can only give approvals to BA/BE studies. If we have to do a PMS whom should we approach for approvals. if this is a pan India study where more than 500 clinics (possibly >50 cities) are participating, is it necessary to take IEC approvals from IEC in each city?

In the present situation, it would not be possible to include private clinics for any clinical trials including phase IV, as these clinics cannot get EC approvals from Independent ECs.

As per CDSCO guidelines, the EC approving the trial should be from the same location. Hence, you would need approval from EC in each city.

One option would be to select one investigator in each city at a hospital/ institution, which has a registered EC authorized to approve clinical trials and have private clinic practitioners could be co-investigators. In this situation, the hospital EC should have an SOP which allows them to approve sites outside their hospital. See Schedule Y excerpt below:

As per Schedule Y, the trial site(s) may accept the approval granted to the protocol by the ethics committee of another trial site or the approval granted by an independent ethics committee (constituted as per Appendix VIII), provided that the approving ethics committee(s) is/are willing to accept their responsibilities for the study at such trial site(s) and the trial site(s) is/are willing to accept such an arrangement and that the protocol version is same at all trial sites.

What are the labelling requirements for the clinical trial medicines in India?

Indian GCP 2.3.1.6.  Handling of the product(s) recommends as follows:
The label should necessarily contain the following information: the words - “For clinical studies only”, the name or a code number of the study, name and contact numbers of the investigator, name of the institution, subject’s identification code.

Can an ayurvedic doctor be a sub investigator?

Indian GCP refers to the term co-investigator for sub-investigator.

Co-investigator - A person legally qualified to be an investigator, to whom the investigator delegates a part of his responsibilities.

As per this definition, only the medical persons who are qualified to be investigators can be considered sub or co-investigator.

US FDA recommends (Investigator Responsibilities Oct 2009) the investigator should ensure that any individual to whom a task is delegated is qualified by education, training, and experience (and state licensure where relevant) to perform the delegated task. An ayurvedic doctor is not qualified in allopathic system. Hence, he/she cannot perform any task which requires qualifications of an allopathic. An ayurvedic doctor can become a research coordinator, but cannot become a sub-investigator.