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Welcome To Supreme
Independent Ethics Committee!

CDSCO Registration Number : ECR/378/Indt/MH/2023

Independent Ethics committee

The Supreme Independent Ethics Committee (hereby called IEC or SIEC) is a legal entity formed by an association of people devoted to protection of human rights, welfare and safety.

The Supreme Independent Ethics Committee will review the research proposal before start of the study as well as monitor the Research project throughout the study until and after completion of the study through appropriate well documented procedures.

The designated Member Secretary and Chairperson will work to establish the Ethics Committee structure and procedures as per applicable clinical trial regulations and guidelines.

Know More
Doctor 1

Autonomous, officially recognized, and Ethics committee with specialized training.

  • Demonstrate robust scientific planning, possess statistical reliability, and adhere to both ICH–GCP guidelines and local regulatory standards during execution.
  • Ensure the safety, rights, and welfare of research study participants are not jeopardized.
  • Carried out under the guidance of medical professionals possessing the necessary experience and expertise.
  • Enroll only those patients who, with the consent of their legally authorized representative, have provided informed consent to participate in the research study.
  • The Committee is available to address ethical concerns at Pune upon request, providing solutions to such issues.

EC Meeting frequency : The EC meeting will be held once in a month.

Doctor 2

Submission of the soft copy of documents is mandatory for approval.

  • The ultimate protocol incorporating all amendments.

  • The Investigator's Brochure and any additional safety-related information that is accessible.
  • The Informed Consent Form and Patient Information Sheet, available in both English and the pertinent translated languages, along with optional back-translations, should be accompanied by the appropriate translation certificates.
  • Any additional documents specific to the project.
  • A preliminary version of the Clinical Trial Agreement should establish a three-party agreement among the sponsor/Investigating Institute, Principal Investigator, and The Supreme Independent Ethics Committee (SIEC) on the other side.
More About Documents
  • The Supreme Independent Ethics Committee (SIEC) has been appointed as per Drugs and Clinical Trials Rules,2019.
  • The Supreme Independent Ethics committee is registered with the CDSCO.