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INSTRUCTIONS and USE OF FORM Use this form only to report deviations from the IRB approved protocols that do not rise to the level of unanticipated problems requiring prompt reporting according to
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How to fill out reporting of unanticipated problems

01
To fill out reporting of unanticipated problems, follow these steps:
02
Begin by describing the unanticipated problem in detail. Include information such as the nature of the problem, when it was discovered, and any relevant background information.
03
Next, explain the potential risks or harm that may result from the unanticipated problem. Provide a thorough assessment of the potential impact on participants or other individuals involved.
04
Identify any immediate actions that were taken to mitigate the risks or address the problem. This may include notifying relevant parties, implementing safeguards, or modifying procedures.
05
Describe any necessary follow-up actions that will be taken to prevent similar problems in the future. This may involve additional training, policy changes, or further investigation.
06
Finally, include any additional documentation or supporting materials that are relevant to the report, such as incident reports, witness statements, or research data.
07
By following these steps, you can ensure that your reporting of unanticipated problems is thorough and informative.

Who needs reporting of unanticipated problems?

01
Reporting of unanticipated problems is necessary for anyone involved in research or clinical trials that involve human subjects or participants. This includes researchers, principal investigators, institutional review boards (IRBs), and regulatory bodies.
02
The purpose of reporting unanticipated problems is to monitor and ensure the safety and well-being of participants, as well as to maintain the integrity and ethical conduct of the research or trial.
03
By promptly reporting and addressing unanticipated problems, researchers and organizations involved can take appropriate measures to minimize risks and ensure the welfare of participants. This helps in upholding ethical standards and maintaining the trust of participants and the wider community.

What is Reporting of Unanticipated Problems - UCI Office of Research Form?

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