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Protocol #: ___(ACTS Use only)Category 3a: Retrospective Medical Record Review Application for Exemption Preprimary Investigator(s), Department, Email:1. 2. 3. Researcher\'s Status (Check One):Undergraduate
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How to fill out change in protocol review

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How to fill out change in protocol review

01
Review the current protocol and identify the specific changes that need to be made.
02
Prepare a document that clearly outlines the proposed changes. Include details such as the specific sections or pages that need revision.
03
Submit the proposed changes to the appropriate authority or review board responsible for protocol reviews. Provide any supporting documents or references as required.
04
Attend any meetings or discussions related to the change in protocol review, if necessary. Be prepared to explain the rationale behind the proposed changes and address any concerns or questions.
05
Revise the protocol document based on the feedback received during the review process. Ensure that all required changes are accurately implemented.
06
Submit the revised protocol for further review and approval. Follow any guidelines or procedures specified by the authority or review board.
07
Once the change in protocol review is completed and approved, ensure that all relevant stakeholders are notified and updated about the changes.
08
Keep a record of the change in protocol review process for future reference or audits.

Who needs change in protocol review?

01
Research institutions conducting clinical trials or experiments may require change in protocol review.
02
Pharmaceutical companies developing new drugs or medical treatments often need change in protocol review.
03
Healthcare organizations implementing changes to existing medical procedures or protocols may also require review and approval.
04
Regulatory bodies or ethics committees overseeing research activities may mandate change in protocol review.
05
Any individual or organization involved in conducting research or implementing new protocols that impact human subjects' safety, data collection, or procedures may need change in protocol review.

What is Change in Protocol Review - Muskingum University Form?

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A change in protocol review refers to the assessment process for modifications to an existing research protocol, ensuring that changes comply with ethical standards and regulatory requirements.
Researchers or institutions conducting studies under an approved protocol are required to file a change in protocol review when they wish to modify the original study design.
To fill out a change in protocol review, researchers should provide detailed information about the proposed changes, including rationale, potential impacts on the study, and any new risks to participants.
The purpose of change in protocol review is to ensure that any modifications made to a research study are ethically justified and do not compromise the safety of participants or the integrity of the research.
Information must be reported on the specific changes being made, the reasons for the changes, any new or modified risks, and the anticipated effects on the study's outcomes or participant safety.
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