Get the free Montefiore Medical Center IRB Reportable Event Form - montefiore

This form is for investigators to report events as outlined in the Internal Adverse Event Policy of Montefiore Medical Center.

How to fill out montefiore medical center irb

How to fill out Montefiore Medical Center IRB Reportable Event Form

1. Obtain the Montefiore Medical Center IRB Reportable Event Form from the IRB website or through your institution's compliance office.
2. Fill in the date of the reportable event.
3. Provide a brief description of the event, including what occurred and why it is reportable.
4. Indicate the study title and IRB number related to the event.
5. Include the names of the principal investigator and key personnel involved.
6. Describe the potential impact of the event on the study's participants.
7. Specify any corrective actions taken or recommended to prevent future occurrences.
8. Sign and date the form before submitting it to the appropriate IRB office.

Who needs Montefiore Medical Center IRB Reportable Event Form?

1. Researchers conducting studies under the Montefiore Medical Center IRB.
2. Key personnel involved in studies that may experience reportable events.
3. Institutional staff responsible for research compliance.

People Also Ask about

What non-compliance must be reported to the IRB?

Examples of non-compliance or deviations include: altering an IRB approved process or documents without prior IRB approval. failure to obtain informed consent from participants. inadequate supervision of research team activities involving human subjects.

What is reportable to the IRB?

A reportable event is an adverse event or other incident that has the potential to be classified by the IRB as an unanticipated problem posing risks to participants or others.

What non-compliance events must be reported to the IRB?

Examples of non-compliance or deviations include: altering an IRB approved process or documents without prior IRB approval. failure to obtain informed consent from participants. inadequate supervision of research team activities involving human subjects.

What needs to be reported to the IRB?

What Events Must Be Reported to the IRB within 10 Working Days? Non-Compliance. Failure to follow the protocol due to the action or inaction of anyone conducting protocol procedures that results in harm to the integrity of the research data. Subject complaint that cannot be resolved by the research team.

What does not require an IRB?

Examples of research that does not require IRB approval include: Internal management projects, such as program evaluation, quality assurance, quality improvement, or marketing studies. Projects that only document or report on events, situations, policies, institutions or systems without the intent to form hypotheses.

What type of adverse events must be reported to the IRB and the FDA no later than 7 calendar days after the incident?

Unexpected fatal or life-threatening suspected adverse events must be reported to the FDA as soon as possible but no later than within 7 calendar days of first being notified of the event.

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What is Montefiore Medical Center IRB Reportable Event Form?

The Montefiore Medical Center IRB Reportable Event Form is a document used to report any events that may affect the rights, safety, or wellbeing of research participants in a clinical study, as mandated by the Institutional Review Board (IRB).

Who is required to file Montefiore Medical Center IRB Reportable Event Form?

Researchers, principal investigators, and any staff involved in a clinical trial are required to file the Montefiore Medical Center IRB Reportable Event Form if an event occurs that meets the reporting criteria.

How to fill out Montefiore Medical Center IRB Reportable Event Form?

To fill out the Montefiore Medical Center IRB Reportable Event Form, provide your contact information, describe the event in detail, explain how it affects the study or participants, and include any actions taken in response to the event.

What is the purpose of Montefiore Medical Center IRB Reportable Event Form?

The purpose of the Montefiore Medical Center IRB Reportable Event Form is to ensure the IRB is informed about significant events that may impact participant safety or research integrity, facilitating timely assessment and appropriate actions.

What information must be reported on Montefiore Medical Center IRB Reportable Event Form?

The information that must be reported includes a description of the event, date and time of the occurrence, details of affected participants, any immediate actions taken, and potential implications for the study and participants.