Can a non medical person (a staff nurse / study coordinator) who is a study team member (and given responsibility by the investigator) sign (countersign) in the ICF? Is there any difference in the regulation in this aspect with Indian GCP and ICH GCP?
Rendeep Rajendran
ICH allows any one designated by the investigator to conduct the consent process. and to sign the consent form.

Indian GCP recommends that the investigator should sign the form. Please see FDA Inspection finding (below) Informed consent obtained by individuals who lack the medical training, knowledge of the clinical protocol, or familiarity of the investigational product needed to be able to discuss the risks and benefits of a clinical trial with prospective subjects.

An EC which had approved the ICF has suggested modifications, whilst all other sites have approved the ICF. How to use two different versions of ICF at different sites?
Shirish Bhatlavande
One option is discuss with EC 1) DCGI approval of ICF 2) difficulties of modifying ICF at 1 site and 3) future issues - audits/inspections etc. If there is no other option but to modify ICF, you will have to use site specific ICF at the site which is asking for revisions, document the same in the site correspondence and notify regulatory agencies.

What documents are required for site registration with DCGI?
Indermohan Sharma
There is no requirement for site registration for clinical trials. As per Schedule Y, as part of protocol approval application, you need to submit an investigator undertaking.
For BA/BE, the site should have been officially audited by DCGI. You can check with DCGI office re: document requirements.

Is there any need that version of all protocol should be same for all participating countries?
Lakshmanan
It depends on 1) which is the final version 2) what are the differences in versions 3) whether the different versions represent the amendments. Usually, we submit the final version of protocol available from the sponsor which is agreed by the investigators and submit the same to DCGI office. Once approved, you need to stick to the same version.

What is exact difference between Post Marketing Surveillance and Phase IV study? How do we differentiate it from marketing promotion?
Sonali Jadhav
Phase IV covers all clinical trials performed according to approved product information after regulatory approval. Post Marketing Surveillance (PMS) studies are part of Phase IV. The focus of PMS studies is assessment of safety of in general population when the drug is prescribed by the doctor. The PMS studies are observational cohort studies. Marketing promotion is not Phase IV or PMS study as the purpose of such studies is to promote use of a new drug. See the definition in Indian GCP.

Phase IV.
Studies performed after marketing of the pharmaceutical product. Trials in phase IV are carried out on the basis of the product characteristics on which the marketing authorization was granted and are normally in the form of post-marketing surveillance, assessment of therapeutic value, treatment strategies used and safety profile. Phase IV studies should use the same scientific and ethical standards as applied in pre-marketing studies.
After a product has been placed on the market, clinical trials designed to explore new indications, new methods of administration or new combinations, etc. are normally considered as trials for new pharmaceutical products.

Does the PMS require protocol and informed consent document or only Case Report Form? If yes does the protocol and informed consent need to be approved by Ethics Committee? What if drug is 4 years old?
Sonali Jadhav
Schedule Y recommend that Phase IV studies should use the same scientific and ethical standards as applied in pre-marketing studies. Hence, protocol, CRF, ICF are to be approved by EC. If the drug is 4 years old, you do not need DCGI approval. However, EC approval is essential.