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Georgia Institute of Technology Institutional Animal Care & Use Committee Protocol Amendment Instructions: This form was created in Word. Fields will expand to accommodate text entry. When complete,
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How to fill out protocol amendment

01
Step 1: Review the original protocol to identify the changes that need to be made.
02
Step 2: Prepare a clear and concise summary of the proposed amendments.
03
Step 3: Create a new document or add the amendments directly to the original protocol.
04
Step 4: Clearly label each amendment with a unique identifier.
05
Step 5: Provide a rationale or justification for each proposed amendment.
06
Step 6: Seek approval from the appropriate governing body or ethics committee.
07
Step 7: Distribute the amended protocol to all relevant parties.
08
Step 8: Update any necessary documentation or records to reflect the changes.
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Step 9: Monitor the implementation of the amendment and assess its impact.
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Step 10: Communicate any further updates or revisions as needed.

Who needs protocol amendment?

01
Protocol amendments are typically required by researchers or organizations conducting studies or clinical trials.
02
Ethics committees may also request protocol amendments to ensure the safety and welfare of participants.
03
In some cases, regulatory authorities may require protocol amendments to address specific concerns or meet regulatory criteria.
04
It is important to consult with the relevant stakeholders to determine if a protocol amendment is necessary.

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A protocol amendment is a change made to the original protocol of a research study, reflecting modifications in procedures, study population, or other important aspects of the study.
The principal investigator or sponsor of the research study is required to file a protocol amendment.
To fill out a protocol amendment, the principal investigator or sponsor must complete the necessary form provided by the Institutional Review Board (IRB) or regulatory agency overseeing the study.
The purpose of a protocol amendment is to ensure that any changes to the original research study are documented, approved, and communicated to all parties involved in the study.
The information that must be reported on a protocol amendment includes details of the proposed changes, rationale for the changes, potential impact on study participants, and any updated study documents.
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