(a) Apart from an MD pharmacology doctor who can be included as basic medical scientist in EC? Can an M. Pharm in clinical pharmacy or non medical person having PG in Biochemistry, Biophysics, Molecular biology etc can be included as basic medical scientist? Can an MD medicine doctor be assigned this role of basic medical scientist if EC has some more clinicians as member? Can an MBBS serve as basic medical scientist?
(b) Social scientist has to be MSW qualification or any graduate working as social worker in a hospital or otherwise can be taken as social scientist in EC?

As per Free Dictionary Medical dictionary basic sciences include anatomy, physiology, biochemistry, molecular biology, pharmacology, microbiology, pathology. Hence, an MD Medicine is not a basic medical scientist. Also a non-medical person cannot serve as basic medical scientist.

As per CDSCO draft guidelines for registration of EC, the basic medical scientist should have post graduate qualifications and adequate experience in his/her respective field. Hence, an MBBS cannot serve as a basic medical scientist.

Social scientist qualifications are not described Sch Y. The free dictionary defines social scientist - someone expert in the study of human society and its personal relationships. So anyone with a degree in the field of social science can serve in this position.

Can sponsor/sponsor representative audit EC? How can sponsor that EC SOPs are adequately followed by EC?

It is unlikely that EC will agree to an audit by the sponsor. Even if EC agrees, there would be issues of confidentiality as EC cannot show files related to other projects.

The sponsor responsibility is not ensuring that EC functions as per its SOP but to ensure that the study is approved by the EC.

As per ICH GCP The sponsor’s responsibility re: EC approval is as follows:

5.11.1    The sponsor should obtain from the investigator/institution:
(a)    The name and address of the investigator's/institution’s IRB/IEC.
(b)    A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws and regulations.
(c)   Documented IRB/IEC approval/favourable opinion and, if requested by the sponsor, a current copy of protocol, written informed consent form(s) and any other written information to be provided to subjects, subject recruiting procedures, and documents related to payments and compensation available to the subjects, and any other documents that the IRB/IEC may have requested

The sponsor can assess SOP compliance by checking the EC approval letter vis-a-vis applicable SOPs.

What is the regulatory requirement in case of change in the investigator?

As per the guidance on approval of clinical trials, the following documents are to be submitted to CDSCO for change in investigator.

1. Covering letter
2. Copy of CT permission letter
3. Copy of previous protocol amendment approval letter, if any
4. Reason for change of Investigator in same site
5. Undertaking from new Investigators as per Appendix VII of Schedule” Y”:-
6. (Ethics Committee should be of same area where the site is located.)
7. CV/ Statement of Qualification
8. Copy of Ethics committee approval letter, if available

How are combination therapies, as practiced for TB, malaria or other diseases, need to be registered as ‘combination therapies’ when individual drugs are registered as monotherapies and are used in the same dose, route but for different durations?

• If the drugs are single drugs to be used as concomitant administration, the package insert will be for single drugs with doses provided for different regimes.
• If the drugs are to be given as Fixed Dose Combination (FDC), the FDC will be approved as a single therapy with dose/duration based on FDC
• If the drugs are to be given as a Combination kits e.g. DOTs therapy, the regime will be of concomitant therapy of individual drugs packed in the DOTs kit.