Get the free RiskBenefit Determination of Amendment - University of Utah

Edit/View Edit: Board Checklist CHK 00027931 Back Save Exit Hide/Show Errors Print... Jump To: Amendment Checklist Page Risk/Benefit Determination of Amendment: Yes No Risk/Benefit ratio remains appropriate

How to fill out riskbenefit determination of amendment

How to fill out riskbenefit determination of amendment:

1. Review the current riskbenefit determination to understand the existing risks and benefits associated with the amendment.
2. Identify the specific changes proposed in the amendment and assess their potential impact on the risks and benefits.
3. Consider any new risks that may arise as a result of the amendment and evaluate their significance.
4. Evaluate the potential benefits that may be gained from the amendment and assess their significance.
5. Compare the potential risks and benefits, taking into account their likelihood and severity.
6. Determine whether the potential benefits outweigh the potential risks or vice versa.
7. Document the riskbenefit determination, clearly stating the rationale behind the decision.

Who needs riskbenefit determination of amendment:

1. Researchers or scientists proposing an amendment to a research study or clinical trial protocol.
2. Regulatory agencies or ethics review boards responsible for reviewing and approving research protocols.
3. Institutional review boards or ethics committees overseeing research studies or clinical trials.

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What is riskbenefit determination of amendment?

Riskbenefit determination of amendment is the process of evaluating the risks and benefits of making changes to a previously approved plan or document.

Who is required to file riskbenefit determination of amendment?

The entity or individual responsible for the original plan or document is typically required to file the riskbenefit determination of amendment.

How to fill out riskbenefit determination of amendment?

The riskbenefit determination of amendment form must be completed by providing specific information about the proposed changes and their potential impacts.

What is the purpose of riskbenefit determination of amendment?

The purpose of riskbenefit determination of amendment is to ensure that any changes made to a plan or document are carefully considered in terms of their potential risks and benefits.

What information must be reported on riskbenefit determination of amendment?

The riskbenefit determination of amendment form typically requires details about the proposed changes, the reasons for making them, and an assessment of their potential impacts.