Review of Amended Protocol / Protocol related documents

7.1 Purpose:       

This describes how protocols, documents and letters are amended and reviewed by the IRB.

7.2 Scope:

This SOP relates to review of amended study protocol / documents and letters that are submitted for IRB approval. Amendments made to study protocols, documents and letters related to the study may not be implemented until approved by the IRB.

7.3. Responsibility:

The IRB secretariat will be responsible to process and manage protocol amendments, documents and letters. The secretariat of the IRB should follow the Procedures for Management of protocol submission.

7.3.1 Receipt of the Amendment Package:

  • The amendment package forwarded by the PI is received by the secretariat within due time.
  • The amendment package should contain covering letter and an amendment reporting form.
  • The following procedures will be followed by the IRB secretary upon receipt of an Amendment package.
    • The member secretary classifies the amendments into minor or major and tables the major amendment on the agenda of the subsequent scheduled meeting.
    • The amendments, documents and letters undergo full IRB review.

7.4: Review of amended protocols/ letters.

7.4.1 IRB decision

  • If the IRB approves the protocol amendments, the Research coordinator/IRB secretary communicates the decision to the PI.
  • If the IRB declines the proposed amendments, the Research coordinator/IRB secretary should immediately notify the Principal Investigator in writing, the decision and the exact reason for not approving the amendment within a specified time.
  • If the IRB recommends or suggests modifications to any of the protocol amendments or documents the Research coordinator/IRB secretary sends a written communication to the PI about the specific changes asking him/her to make the necessary changes and resubmit the documents to IRB within due specified time.

 7.4.2 Storage of documents:

The amendments to the protocols, documents and letters related to the study will be stored in the corresponding research protocol file.

7.4.3: Minor amendments and notifications

Minor amendments include those that do not increase the risk or decrease the benefit potential to participants.

These can be approved by the IRB member secretary in consultation with lead discussant assigned originally for the study protocol.

Minor notifications are noted to the IRB chairman and may not be tabled in the IRB meeting.

This may include the following but may not be restricted to:

  • Renewed Insurance Policy
  • DCGI and DGFT approvals
  • Administrative notes, etc.