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Guidelines

What is a Protocol Amendment

A protocol amendment occurs when there is a requirement for any change to the approved protocol. Unless there is an immediate hazard, any protocol amendment must be approved by both the IMR IRB and the MRAC, prior to implementation of the change(s).

Steps to Follow

  1. Identify the requirement for an amendment to the approved protocol.

  2. Mark required changes on a copy of the approved protocol, ensuring that the changes can be clearly identified. Microsoft word "Track Changes" can be used for this purpose.

  3. Complete the IMR Institutional Review Board Protocol Amendment Pro Forma.

  4. Submit the "marked" copy of the protocol together with the IMR Institutional Review Board Protocol Amendment Pro Forma electronically to imrirb@pngimr.pg.org or alternatively by post to:

      IMR Institutional Review Board
      Papua New Guinea Institute of Medical Research
      PO Box 60
      Goroka, EHP 441
      Papua New Guinea

  5. IMR IRB will automatically forward protocol amendments to the MRAC. You do not need to submit any additional paperwork


IMR Institutional Review Board

Contact

Dr William Pomat
IRB Secretary

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