Conditional approval letter is not valid for regulatory approval

A trial sponsor has made an inquiry regarding a study approved by our EC, which is now closed. The sponsor would like to retrieve information from the medical records of patients who were early terminated from the study. This information is required to assist the sponsor in their response to questions from the regulatory authorities. Does this request require EC review? Would subjects need to be re-consented for this data collection?

As the study has been closed, and the sponsor needs additional information from the patient’s medical records that was not part of the study protocol, this additional data collection would be subject to EC review.

The subjects would need to be re-consented for this data collection as this is a new data collection that was not part of their informed consent

How do we determine conflict of interest for membership of EC?

In an institutional EC, all members except the independent member – chairperson -  who is from outside the institute, will by definition, have some conflict of interest since all will have a vested interest in the functioning of the institution where they are employed. However, individuals with a vested interest in a specific study - clinical investigators, sub-investigators, study staff, and spouses of all such study staff - would be considered to have a conflict large enough to require them to recuse themselves from any decisions on the study if they are a member of the EC. For all other real or potential conflicts, it is up to the discretion of the EC and/or the institution. The EC/ institution should have written policy/SOP for handling issues of conflict of interest.
 
In the absence of some documents, information/statements in the study protocol can EC accord conditional approval and allow them to submit the study protocol to CDSCO for approval?

The term conditional approval does not exist in regulations/ Schedule Y. When the EC gives conditional approval, it requires that the investigator should obtain regulatory approval before initiating the trial.

If any documents are not submitted/corrected, the EC cannot give approval. However, if an EC gives conditional approval, when some documents are not submitted/corrected, the letter of conditional approval is not valid for regulatory approval.

In practical terms, as the DCGI does not insist on submitting EC approval as part of the regulatory submission, the sponsor can submit regulatory application without waiting for EC approval.

Can CDSCO issue show cause notice to EC chairman in the first instance itself even without asking once before regarding discrepancies in the study protocol? What will be the type of action taken by CDSCO explanation given by EC is not satisfactory?

EC registration (122DD) stipulates as follows:
If the Ethics Committee fails to comply with any of the conditions of registration, the Licensing Authority may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefore, suspend or cancel the registration of the Ethics Committee for such period as considered necessary.

I had a doubt with regard to DCGI submission. EC has conditionally approved 1st  version of a protocol subject to some changes. We had to amend the protocol two times and resubmit to EC for approval. Now which version needs to be submitted to DCGI? Should it be the 1st version or final version which has EC approval?

If you plan to submit a clinical trial application after EC approval, it is advisable to submit final version of protocol approved by the EC.