Q. What does the chairperson do if he/she has a conflict of interest situation with a study submitted for EC review?
● Dr. Sreevats
The usual process is 1) to declare the conflict of interest to all EC members before the protocol is discussed and 2) to exit from the discussions. In the absence of the chairperson, either the vice-chairman or any of the other members can chair this meeting. The EC minutes should document all this information.
Q. What are the guidelines for forming an independent ethics committee? Is it possible for a CRO to form an IEC? If so, do we have to take any approvals from regulatory authorities?
● Vinod Kumar
The guidelines for ethics committee composition and functioning are given in Schedule Y Appendix VII and ICMR Ethics Guidelines 2006. There is no law prohibiting a CRO from setting up its own ethics committee, provided it adheres to the letter and spirit of the guidelines. The crucial thing for ethics committee is to be really independent of the CRO. At present, there is no approval process. However, once the legislation of ICMR guidelines occurs by the Ministry of Health, a Biomedical Research Authority will be set up under the proposed Bill on Biomedical Research on Human Participants (Promotion and Regulation). All IECs will need to register with this authority.
Q. Do we have any regulations that require notification to regulatory authorities of fraud/serious breach in
clinical trials?
● Dr. Ashutosh Shah
The regulatory provisions are given below. There is no time frame or format. However, the term used in Indian GCP is "prompt action". I feel as we are becoming a global clinical trial country, we should follow the formats / time lines for such complaints in line with US FDA / EMEA expectations.
Schedule Y
The clinical trial sponsor is responsible for implementing and maintaining quality assurance systems to ensure that the clinical trial is conducted and data generated, documented and reported in compliance with the protocol and Good Clinical Practice (GCP) Guidelines issued by the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India as well as with all applicable statutory provisions.
Indian GCP
Sponsor should initiate prompt action in case it is discovered that any party involved has not entirely complied with the GCP, SOPs, Protocol and / or any applicable regulatory requirements. If monitoring / auditing identify serious and / or persistent noncompliance - the sponsor should terminate the defaulting party's participation in the study and promptly notify to the regulatory authority.
Pl note that the Drugs & Cosmetics Amendment Bill 2007, which is awaiting Parliament approval, describes punishment for conducting trials which is not in accordance with permission from DCGI office.
Q. A site has experienced an SAE and initial form of SAE is filled and signed and dated by investigator of the site. The investigator has to go outside country. The follow up report for the SAE is pending. Can the investigator assign the responsibility to his co-investigator?
● Sunil Verma
The co-investigator can sign. But there should be an entry in source data and on the SAE form, why he signed. The SAE form has to be signed by PI on his return and resent to the sponsor. The CRA should document this GCP deviation in the monitoring report and in the follow-up letter to the site.
Q. What are the differences between Indian GCP and ICH GCP? Which has to be followed in India?
● Namrata Singh
There are no differences if you look at the spirit of Indian and ICH GCP. However, some sections - e.g. ethics are quite different. Schedule Y recommends that the sponsor should follow GCP guidelines issued by CDSCO. However, if you are conducting an international trial in India, you need to follow both ICH GCP and Indian GCP.