KEM Hospital Research Centre, Pune

K.E.M Hospital, Pune celebrated its diamond jubilee in 1972. At that time a need was felt to further improve and expand their services.Read Further

EC FAQs:

1] What are the EC fees for approving a project?

Ans: The KEMHRCEC charges a fee of Rs. 1,00,000/- (One Lakh rupees only) for reviewing a research proposal, including following the progress of an approved project to its completion, closure or termination.

2] Is GST included in the EC fees?

Ans: No. 18% GST is not included in EC fees it should be paid over and above the EC fees.

3] In whose name should the cheque be drawn for payment of EC fees?

Ans: The EC fees cheque should be drawn in favour of “The Director, KEM Hospital Research Centre, Pune” submitted along with the research proposal.

4] What are the charges for new /amended documents?

Ans: Excluding the DCGI/ Directorate General of Foreign Trade (DGFT) approval letter, Insurance Certificate and Clinical Trial Agreement (CTA) a fee of Rs. 3000/- (Three Thousand only) will be charged per additional/ amendment document which is submitted for approval after the project has been initially approved. This fee is to be paid at the time the document is being submitted and is applicable to all projects.
An amendment in the protocol which shall lead to related changes in the Informed Consent Form (ICF) will also be charged. Therefore, when such submissions are made for approval, the ICFs will be considered as one document for the calculation of fees. An upper limit of Rs. 30000/- shall be charged for the submission of 8 or more amended documents for approval at one time.

5] Are an expedited meetings conducted & what are the charges?

Ans: Expedited meetings are conducted and charges are Rs.1,50,000/- lakh per protocol. Expedited meeting for amended documents related to regulatory studies, a fee of Rs. 50,000/- and for any documents related to non-regulatory studies, a fee of Rs. 30,000/- shall be charged at the time the document is being submitted.

6] What is the list of documents required for initial submission?

Ans: A set of 11 hard copies of a set of documents, please refer to (SOP-3 of point3.1 appendix I) and a CD pertaining to the research proposal should be submitted for consideration by the KEMHRCEC.

7] How long does it take for EC approval?

Ans: It takes 7-15 days after the EC meeting for getting an approval letter.

8] Does the EC have DCGI approval?

Ans: Yes. Please check website www.kemhrcpune.org

9] Is the EC NABH accredited?

Ans: Yes. Please check the website www.kemhrcpune.org

10] Is there any archival facility and what are the charges?

Ans: Yes, there is archival facility and the cost is 1 lakh for 15 years.

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