The IEC at Clinnovo Research Labs aims to Ensure protection of the rights, safety and well-being of human subjects involved in a research project on drugs, devices, procedures, and etc. By being an independent reviewer we Provide public and un-biased assurance of that protection.

Membership

This committee is an independent body constituted of medical, scientific and lay members. It consists of 11 members who collectively have the qualifications and experience to review and evaluate the scientific, medical and ethical aspects of a proposed research project. In addition, a separate panel of experts forms the Scientific Advisory Committee.

Address for correspondence

Administrative Officer
Independent Ethics Committee
203,204 Concorde Apartments,
Next to Civil Supplies Bhavan,
Erramanzil, Somajiguda,
Hyderabad -82.
Phone :040-40040827
e-Mail : contact@clinnovo.com

Services offered

1. Initial Review
2. Protocol & protocol related amendments
3. Continuing Review
4. Additional site

Initial Review

The documents to be forwarded for review and approval of the project to the Independent Ethics Committee are as follows:-

Item	Document title	Number of copies
1	Study Protocol	13
2	Protocol Amendments (if any)	13
3	Case Record Form	13
4	Informed Consent Form (English & Vernacular language)	13
5	Amendments to the ICF (if any)	13
6	Translation of Informed Consent Form & Back Translation Certificate	13
7	DCGI Approval letter/Package insert (Whichever is applicable)	13
8	Confirmatory note from the Principal Investigator stating that the above mentioned trial will be conducted in accordance with Schedule Y and Ethical Guidelines for Biomedical Research on Human participants; ICMR 2006.	13
9	Investigator Brochure	13
10	Insurance policy & Indemnity letter	13
11	1 page CV of Principal Investigator	13
12	Site profile	13
13	Principal Investigator Undertaking and Consent letter	13
14	Project Submission Application form	13
15	No Objection Certificate from the Dean/MS/Director of the Institute and Institutional Ethics Committee Chairperson of the functioning Institutional Ethics Committee	13
16	Clinical Trial Agreement	13
17	Trial Budget depicting allocation of funds for trial related activities	13
18	Ethics Committee clearance of other centers	13

The documents need to be submitted at least 15 days prior to the meeting date.

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Protocol & protocol related amendments

The documents to be forwarded to the Independent Ethics Committee for review and approval of protocol and protocol related amendments for projects already approved by the IEC are as follows:-

Item	Document title	Number of copies
1	Protocol amendment with the changes highlighted in the document	13
2	ICF (English/vernacular languages) with the changes highlighted in the document (if protocol amendment reflects any change in ICF	13
3	Back translation certificates (if applicable)	13
4	IB with the changes highlighted in the document (if protocol amendment reflects any change in IB)	13

The documents need to be submitted at least 15 days prior to the meeting date

Continuing Review

The documents to be forwarded to the Independent Ethics Committee for review and approval of project extension for projects approved earlier by the IEC are as follows:-

Item	Document title	Number of copies
1	Continuing Review Application Form	13
2	Annual progress report	13

The documents need to be submitted at least 15 days prior to the meeting date.
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Additional site

The documents to be forwarded to the Independent Ethics Committee for review and approval of an additional site for projects already approved by the Independent Ethics Committee are as follows:-

Item	Document title	Number of copies
1	Project Submission Application Form	1
2	Principal Investigator Undertaking	1
3	Confirmatory note from the Principal Investigator stating that the above mentioned trial will be conducted in accordance with Schedule Y and Ethical Guidelines for Biomedical Research on Human participants; ICMR 2006.	1
4	1 page CV of Principal Investigator	1
5	Site profile	1
6	No Objection Certificate from the Dean/MS/Director of the Institute and Institutional Ethics Committee Chairperson of the functioning Institutional Ethics Committee	1

The documents need to be submitted at least 15 days prior to the meeting date.

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