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HP TN Critical Event Reporting FormInstructions: This form is to be completed once an event is determined by NIH staff to qualify as a Critical Event. Sites are to follow HP TN specific protocol deviation
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How to fill out hptn critical event reporting

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How to fill out hptn critical event reporting

01
To fill out HPTN critical event reporting, follow these steps:
02
Begin by opening the HPTN critical event reporting form.
03
Fill out the required information at the top of the form, including the participant ID, study name, and other relevant identifiers.
04
Provide a detailed description of the critical event, including the date and time it occurred, the location, and any other relevant details.
05
Indicate the severity of the critical event using the provided scale or criteria.
06
Describe any actions taken in response to the critical event, including medical interventions, changes in study protocol, or other necessary measures.
07
Identify any potential causes or contributing factors to the critical event, if known.
08
Fill out the contact information section, including the names and contact details of individuals involved in managing the critical event.
09
Review the completed form for accuracy and completeness.
10
Submit the HPTN critical event reporting form to the designated personnel or department as instructed.

Who needs hptn critical event reporting?

01
HPTN critical event reporting is essential for:
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- Researchers conducting clinical trials or research studies within the HPTN network
03
- Study coordinators and investigators responsible for monitoring and managing participant safety
04
- Institutional review boards (IRBs) or ethics committees overseeing the study
05
- Data safety monitoring boards (DSMBs) and other regulatory bodies
06
- Sponsors or funding organizations supporting the study

What is HPTN Critical Event Reporting Form?

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Instructions for the HPTN Critical Event Reporting form

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HPTN critical event reporting is a process for reporting significant incidents or events that may impact the HPTN project.
All HPTN project staff members are required to file hptn critical event reporting.
HPTN critical event reporting can be filled out electronically using the designated reporting form.
The purpose of hptn critical event reporting is to ensure transparency, accountability, and prompt response to any significant events within the HPTN project.
Information such as date, time, location, description of the event, individuals involved, and any actions taken must be reported on hptn critical event reporting.
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