An institute cannot add another unit without CDSCO approval

The Principal Investigator of one of the centres (1st) of an Institute got permission from the DCGI to carry out a sponsored study with the subject drug at its centre (1st). With the same DCGI approval letter the institute wants to carry out the same study at its another centre (2nd) with separate Principal Investigator. Will the EC approval is sufficient to carry out the study at the 2nd centre?
Dr Sreevatsa

The institute cannot add another site without CDSCO approval. As per clinical trial check list, the sponsor has to apply to CDSCO with the following documents to get approval of the 2nd site:

• Covering letter
• Copy of CT permission letter
• Copy of previous protocol amendment approval letter, if any
• Undertaking by the investigators as per Appendix VII of Schedule” Y”:-
• Ethics Committee should be of same area where the site is located
• CV/ statement of qualification
• Furnish details on the total number of trials being undertaken currently by the proposed investigator.
• Copy of ethics committee approval letter, if available
• Whether the clinical study site is a private clinic/private hospital/nursing home/ govt. hospital.
• Details of the medical facility/hospitals: Number of beds, whether it is equipped with super specialty or multi-specialty facilities and emergency facilities.
• Whether the study site has institutional ethics committee or independent ethics committee
• Name, address and registration number of institutional ethics committee.

Can an ayurvedic or homoeopathic doctor work in BA/BE centre/studies for screening, managing all medical related work including AEs/SAEs?
Dr Nitin Kulkarni

The US FDA 2009 guidance for investigator responsibilities recommends as follows:

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. Appropriate delegation is primarily an issue for tasks considered to be clinical or medical in nature, such as evaluating study subjects to assess clinical response to an investigational therapy (e.g., global assessment scales, vital signs) or providing medical care to subjects during the course of the study. Most clinical/medical tasks require formal medical training and may also have licensing or certification requirements. Licensing requirements may vary by jurisdiction (e.g., states, countries). Investigators should take such qualifications/licensing requirements into account when considering delegation of specific tasks.

As ayurvedic or homeopathic doctors are not qualified by education and do not have MCI registration, it would not be proper for them to be involved in tasks considered to be clinical or medical in nature.

Do we need DCGI approvals for conducting 'claim substantiation' studies with cosmetic products?
Sneha Gupta

You need to check whether the claim falls in the category of a new indication/ unapproved indication. If so, the cosmetic would be considered a new drug. In such a case CDSCO approval would be required.

We have formed an Interdisciplinary Research Organization with the aim to promote quality research works in Ayurveda. We have also formed an Independent Ethical Committee. We want to know how and where to register our Ethical Committee?

Dr Aravind

If your EC does not plan to review/approve any clinical drug trials which require approval of DCGI, there is no need to register the EC. However, if you wish to review such trials, you need to register the EC with CDSCO.

Can a clinical research person (CRA/CRC) be a member of EC of any hospital?
Tushar Mhetre

This situation requires consideration of following issues:

• Does EC SOP permit such a person to be on EC? Many ECs do not allow an industry person to be on the EC.
• Which category of EC membership from the composition will CRA/CRC represent? Most CRA/CRCs are science graduate/PGs. Hence, they cannot become non-scientist / lay member. They may not be able to represent other categories - medical, legal, social worker, etc.
• How will CRA/CRC manage conflict of interest? If CRA/CRC works on multiple projects, he/she will have to abstain from voting on such projects.