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IRB Administration Office 87 E. Canfield, Second Floor Office(313) 5771628 Detroit, MI48201http://irb.wayne.edu/index.phpHuman Participant Research Determination Tool The regulatory requirement for
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How to fill out follow-up unanticipated problem report

01
To fill out a follow-up unanticipated problem report, follow these steps:
02
Start by providing the necessary contact information, including your name, email address, and phone number.
03
Next, provide a detailed description of the unanticipated problem. Include any relevant information such as the date and time it occurred, any symptoms or side effects experienced, and the impact it had on the individual.
04
Identify any potential causes or contributing factors to the problem. This may involve reviewing any relevant medical records or consulting with other healthcare professionals.
05
Describe any actions taken to address the problem or mitigate its impact. This may include changes in medication, additional medical treatments, or any other interventions.
06
Provide an assessment of the severity of the problem and its potential consequences. This can help healthcare professionals prioritize their response and take appropriate action.
07
Finally, include any additional information or documentation that may be relevant to the report. This could be in the form of laboratory test results, medical imaging, or witness statements.
08
Make sure to review the completed report for accuracy and completeness before submitting it to the appropriate authority or healthcare oversight organization.

Who needs follow-up unanticipated problem report?

01
Follow-up unanticipated problem report is typically required by healthcare professionals and organizations who are responsible for patient safety and medical oversight.
02
This can include physicians, nurses, pharmacists, and other healthcare providers who encounter unanticipated problems or adverse events in their practice.
03
Healthcare organizations, such as hospitals, clinics, and research institutions, also need to report and address unanticipated problems to ensure patient safety and quality of care.

What is Follow-Up Unanticipated Problem Report - research.wayne.edu Form?

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It is a report submitted to provide additional information or updates on an unanticipated problem that was previously reported.
The individuals or organizations responsible for reporting the initial unanticipated problem are required to file the follow-up report.
The follow-up report should include any new details or developments related to the previously reported unanticipated problem.
The purpose is to ensure that all relevant information regarding unanticipated problems is documented and communicated to appropriate authorities.
The report should include updates on the problem, any additional impacts or risks identified, and any actions taken or planned in response to the problem.
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