Q. Can a QA-auditor become the member secretary of the EC for the same study?
● Arulsingh Jayaraman
We need to consider this from several angles vis-à-vis responsibilities of a member of EC. As per GCP, the EC member will be involved in initial review, progress report review, SAE review, notifications/amendments, final report review and decisions of termination of a study. The question is what will be implications if QA person becomes an EC member? How will the QA per son separate 2 roles - one as a member and another as an auditor? An auditor's role is to audit a study usually at the conclusion of the study and make observations on quality based on available documents and based on facts without any bias. If the auditor is a member of the EC, s/he will get information about the study through EC documents and will form his/her opinion about the study before the audit. This can make him/her biased about the study. Hence, it does not appear prudent to have QA-auditor as member secretary of the study.
Q. Can an institutional/independent ethics committee approve the protocol of a study being planned by other organizations?
● S Gurunath
It can approve the study of other organizations provided 1) the committee is really independent (not attached to any company) 2) the other organizations accept its authority in writing to approve and oversee the conduct of trial at their center. 3) the committee's SOPs permit this.
Q. Can an institutional/independent ethics committee located in a city approve the protocol of a study being planned by other organizations in another city?
● S. Gurunath
The issue is not whether they can give approval or not. The issue is) how they will protect rights, safety & well being of subjects located in another city 2) oversee the study in another city 3) review and monitor issues e.g. serious adverse events This is not logistically possible for an EC of another town unless the EC chairperson / secretary are willing to travel to the other location for regular oversight of the study.
Q.What is to be done if the site has missed to record or report some protocol deviations to IEC and Sponsor particularly when these deviations were noted after the end of the study?
● Dr Virupaksh Mahaparale
As per Indian GCP IEC requires notification on the following items. The following circumstances require the matter to be brought to the attention of IEC:many amendment to the protocol form the originally approved protocol with proper justification; mserious and unexpected adverse events and remedial steps taken to tackle them; many new information that may influence the conduct of the study.
IEC does not expect information on all protocol deviations. Indian GCP requires that the monitor should promptly inform the sponsor and the ethics committee in case any unwarranted deviation from the protocol or any transgression of the principles embodied in GCP is noted.If the protocol deviations are unwarranted and / or represent transgression of the principles embodied in GCP, then you need to inform IEC
If the deviations are minor, they are covered in the monitoring report, documented in protocol deviation form/log and described in the final study report. A copy of final study report has to be submitted to IEC.
Q. Who is authorized to sign for ethical approval in India - the chairman or the member secretary?
● Dr Suresh Athreya
Either can sign usually member secretary. However, this should be as per EC SOP
Q.We want to conduct clinical trials in India, for the products that registered in other countries, but new to Indian Market. What procedure should we follow for this? Besides, are there any guidelines available for conducting clinical trials in India?
● Nikita Varshney
Pl see the website www.cdsco.nic.in - official website of Drugs Controller General's Office. The website has links to Drugs & Cosmetics Rules, amended Schedule Y and Indian GCP. These are the regulations for conducting clinical trials in India.