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Title Review of Unanticipated Problems in Human-Subjects Research Department Human Research Affairs/Research Management Partners System-wide Template Partners Corporate Policy Type Entity Applies to Employees Professional Staff or Other Agents of Brigham and Women s Hospital BWH Faulkner Hospital FH and Massachusetts General Hospital MGH Approved by Chief Scientific Officer Approval Date December 6 2007 Effective Date Revision Date s November 19 2010 Next Review Date Contact Person Director...

How to fill out review of unanticipated problems

How to fill out review of unanticipated problems?

1. Identify the unanticipated problems that have occurred. This could include any unexpected events, failures, or incidents that were not foreseen during the planning or implementation stages.
2. Gather all relevant information about the problems. This may involve interviewing individuals involved, collecting data, reviewing documentation, and examining any evidence related to the problems.
3. Analyze the causes of the unanticipated problems. Try to identify the root causes or contributing factors that led to the occurrence of these problems. This could involve assessing the procedures, protocols, or systems in place.
4. Evaluate the impact of the problems. Consider the consequences or effects that the unanticipated problems have had on the project, organization, or individuals involved. Assess the severity or significance of these impacts.
5. Develop recommendations for addressing the problems. Based on the analysis and evaluation, propose actions or strategies to prevent similar problems in the future. This may include changes to procedures, protocols, resources, training, or any other relevant factors.
6. Document the review of unanticipated problems. Ensure that all findings, analysis, evaluation, and recommendations are recorded in a clear and comprehensive manner. Maintain proper documentation for future reference or review.

Who needs review of unanticipated problems?

1. Project managers: They need to review unanticipated problems to understand the impact on the project's timeline, budget, and objectives. They also need to identify strategies to mitigate the risks associated with such problems.
2. Risk management teams: They need to review unanticipated problems to assess their likelihood of recurrence and identify measures to prevent or mitigate them in future projects.
3. Quality assurance teams: They need to review unanticipated problems to assess whether the existing quality control measures are effective and identify areas for improvement.
4. Stakeholders: They need to review unanticipated problems to assess the project's overall performance and the organization's ability to handle unexpected challenges. They may also need to make decisions based on the review findings.

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What is review of unanticipated problems?

The review of unanticipated problems is a process that allows researchers and organizations to assess and document any unexpected events or issues that arise during a research study.

Who is required to file review of unanticipated problems?

Researchers and organizations conducting research studies are required to file a review of unanticipated problems.

How to fill out review of unanticipated problems?

To fill out a review of unanticipated problems, researchers and organizations need to provide a detailed description of the problem, its impact on the study, any actions taken to address it, and any necessary reporting to regulatory bodies.

What is the purpose of review of unanticipated problems?

The purpose of the review of unanticipated problems is to ensure the safety and well-being of research participants, as well as the integrity and validity of the research study.

What information must be reported on review of unanticipated problems?

The review of unanticipated problems must include information such as the nature of the problem, the number of participants affected, any actions taken to address the problem, and any potential risks or implications for future research.