Universal Ethics Committee

CDSCO and USFDA OHRP Registered Ethics Committee, Chennai

Studies Accepted for Review…

• Bio Equivalent (BA-BE) Study
• Post Marketing Surveillance (PMS) Study
• PG/PhD Thesis Study
• Ayurveda / Siddha Clinical Study.
• Nutraceuticals & Food Supplements Study.

Universal Ethics Committee (UEC) accepts Clinical Study Protocol & Annexures for submission a minimum of 5 days prior to a meeting.

UEC charges nominal meeting convention fees and offers concessions for PG/PhD thesis submissions.

Process of Submission to UEC…

• We require the following documents to be submitted as both printed copies and as electronic copies.
  1. Clinical Study Protocol
  2. Informed Consent Documents (English & Vernacular)
  3. Case Report Form, Questionnaires etc,
  4. Investigator’s Brochure.
  5. Subject Compensation & Study Insurance Details
  6. Investigator – Copies of CV, MRC, Undertaking.
• You will receive communication by email and phone regarding the next UEC Convention Date.
• A small presentation of the clinical study is expected by the Investigator or his representative.
• Within 2 working days, you will receive a Minutes of Meeting Record (MoM) from UEC citing the details of the meeting. Any queries raised by UEC members must be addressed.
• Once the queries in the MoM, are resolved, within 1 working day, UEC will tenders its decision in the written form. The approval form will be provided as both printed and electronic copies for your records.