The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human participants, but at least once a year.

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Quorum Requirement

  • According to New Drug CT rule_2019, minimum of 7 members are required to compose a quorum. All decisions must be taken in meetings and not by circulation of project proposals. Minutes of Meeting along with the list of members present during the meeting must be maintained.
  • • Chairperson
    • Basic Medical Scientist
    • Member Secretary
    • Clinician
    • Legal Expert
    • Social Scientist / Representative of NGO / Ethicist / Theologian.
    • Lay person from community

  • A minimum of five members present in the meeting room.
  • The quorum should include both medical, non-medical or technical or/and non-technical members.
  • Preferably the lay person should be part of the quorum.
  • The quorum for reviewing regulatory clinical trials should be in accordance with current CDSCO requirements.
  • No decision is valid without fulfillment of the quorum.