Regarding IRB [GxP / QC / QA]

posted by kiranActimus – India, 2009-08-08 19:47 (5755 d 09:07 ago) – Posting: # 4021
Views: 2,887

Dear All

I have some doubts regarding the Institutional review board.
  1. We have a institutional review board to approve studies conducted at our facility (India) but no member is from the organization. Is it mandatory to have a member from the organization in a Institutional Review Board?
  2. All the approval letters of the Protocol drafted to the organization is by the chairman or Vice Chairman only but as per Schedule Y (CDSCO) the approval letter need to communicated by the Member Secretary. Please suggest me how to address this issue?
  3. Our IRB approves the Protocol and ICFs by stamping IRB approved on the Protocol and Chairman or Vice chairman signs on it. Please clarify me whether Chairman or Vice chairman sign the Protocol is acceptable or member secretary needs to sign the approved protocol
  4. We do not have a dedicated member secretary for the Board and one of our employee is acting as secretary of IRB. Is it acceptable?
  5. Whether the SOPs of IRB can be approved by the Vice chairman or is it mandatory that the SOPs shall be approved by the chairman only.

Waiting for your valuable suggestions.


Thanks & Regards
KK

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