A clinical trial to support marketing in US/Europe has to conduct multi country trial with India as one of the countries

Kindly clarify how long the study documents will be archived

The requirements are as follows:
EU Commission
for at least 15 years after completion or discontinuation of the trial,
or for at least two years after the granting of the last marketing authorization in the European Community and when there are no pending or contemplated marketing applications in the European Community,
or for at least two years after formal discontinuation of clinical development of the investigational product.

US FDA  
An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or,
if no application is to be filed or
if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified

With respect the expedited review by the ethics committee, what is the requirement for expedited review for the ethics committee?


Indian GCP describes this under Interim Review whilst ICMR gives detail recommendation. The requirements of document submission will be as per Schedule Y
Indian GCP 4.2.7.            Interim Review
The IEC should decide and record the special circumstances and the mechanism when an interim review can be resorted-to instead of waiting for the scheduled time of the meeting. However, decisions taken should be brought to the notice of the main committee. This can be done for the following reasons:
i) re-examination of a proposal already examined by the IEC;
ii)  research study of a minor nature such as examination of case records etc.;
iii)  an urgent proposal of national interest.

ICMR 2006 2. Expedited Review
The proposals presenting no more than minimal risk to research participants may be subjected to expedited review. The Member-Secretary and the Chairperson of the IEC or designated member of the Committee or Subcommittee of the IEC may do expedited review only if the protocols involve:-
1. Minor deviations from originally approved research during the period of approval (usually of one year duration).
2. Revised proposal previously approved through full review by the IEC or continuing review of approved proposals where there is no additional risk or activity is limited to data analysis.
3. Research activities that involve only procedures listed in one or more of the following categories:
a. Clinical studies of drugs and medical devices only when -
i. research is on already approved drugs except when studying drug interaction or conducting trial on vulnerable population or
ii. adverse event (AE) or unexpected adverse drug reaction (ADR) of minor nature is reported.
4. Research involving clinical materials (data, documents, records, or specimens) that have been collected for non-research (clinical) purposes.
5. When in emergency situations like serious outbreaks or disasters a full review of the research is not possible, prior written permission of IEC may be taken before use of the test intervention. Such research can only be approved for pilot study or preliminary work to study the safety and efficacy of the intervention and the same participants should not be included in the clinical trial that may be initiated later based on the findings of the pilot study.
a. Research on interventions in emergency situation
When proven prophylactic, diagnostic, and therapeutic methods do not exist or have been ineffective, physicians may use new intervention as investigational drug (IND) / devices/vaccine to provide emergency medical care to their patients in life threatening conditions. Research in such instance of medical care could be allowed in patients
i. when consent of person/ patient/ responsible relative or custodian/ team of designated doctors for such an event is not possible. However, information about the intervention should be given to the relative/ legal guardian when available later;
ii. when the intervention has undergone testing for safety prior to its use in emergency situations and sponsor has obtained prior approval of DCGI;
iii. only if the local IEC reviews the protocol since institutional responsibility is of paramount importance in such instances.
iv. if Data Safety Monitoring Board (DSMB) is constituted to review the data;
b. Research on disaster management
A disaster is the sudden occurrence of a calamitous event at any time resulting in substantial material damage, affecting persons, society, community or state(s). It may be periodic, caused by both nature and humans and creates an imbalance between the capacity and resources of the society and the needs of the survivors or the people whose lives are threatened, over a given period of time. It may also be unethical sometimes not to do research in such circumstances. Disasters create vulnerable persons and groups in society, particularly so in disadvantaged communities, and therefore, the following points need to be considered when reviewing such research:
i. Research planned to be conducted after a disaster should be essential culturally sensitive and specific in nature with possible application in future disaster situations.
ii. Disaster-affected community participation before and during the research is essential and its representative or advocate must be identified.
iii. Extra care must be taken to protect the privacy and confidentiality of participants and communities.
iv. Protection must be ensured so that only minimal additional risk is imposed.
v. The research undertaken should provide direct or indirect benefits to the participants, the disaster-affected community or future disaster-affected population and a priori agreement should be reached on this, whenever possible, between the community and the researcher.
vi. All international collaborative research in the disaster-affected area should be done with a local partner on equal partnership basis.
vii. Transfer of biological material, if any, should be as per Government rules taking care of intellectual property rights issues.

I am writing this seeking your help on resolving an issue related to change of PI.
PI of a running trial wishes to relinquish his role and has suggested another investigator. Later it was found that the suggested PI is the member of EC who was present in some of the meetings where some of the documents ( Protocol amendments and revised ICFs) related to this study were reviewed.  However, the suggested PI was absent when the study was first submitted and was given conditional approval. Would this become a finding?

It appears that the new PI is a member of EC. However, when the protocol was reviewed by EC, he was not a PI. Hence, there was no conflict of interest for him at that time. He could take part in discussions and could vote as he was not the PI.

For a trial to be conducted in India, support marketing in US/Europe, whose approval is required? Which guideline should be followed?


For trial to support marketing in US/Europe, you have to conduct multi country trial with India as one of the countries. The IND approval has to be taken from the US/European authorities for the global trial and from DCGI in India. The trial has to comply with regulations in US/Europe, ICH-GCP, Schedule Y and Indian GCP.