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Get the free NSU-IRB Submission Form for Continuing Review - nova

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Este formulario es obligatorio para los investigadores principales que necesitan realizar una revisión continua de estudios aprobados por el IRB. Requiere que se completen todas las secciones pertinentes
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How to fill out NSU-IRB Submission Form for Continuing Review

01
Start by downloading the NSU-IRB Submission Form for Continuing Review from the official NSU website.
02
Read the instructions carefully to understand the requirements.
03
Fill out the project title and Principal Investigator (PI) details in the top section of the form.
04
Indicate the research project number and provide the date of the last IRB approval.
05
Complete the sections for study progress, including any recruitment updates and changes to the protocol.
06
Provide details on any adverse events that occurred since the last review.
07
Include any amendments or modifications made to the study protocol.
08
Ensure that you attach any necessary documents, such as consent forms or recruitment materials, if applicable.
09
Review the entire form for completeness and accuracy.
10
Submit the completed form electronically to the NSU IRB office before the submission deadline.

Who needs NSU-IRB Submission Form for Continuing Review?

01
Researchers and Principal Investigators who are conducting studies involving human participants that require ongoing oversight.
02
Any institution or individual affiliated with NSU who has received IRB approval for a research project.
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About the Submission Process: The PI must submit the initial application. A Primary Contact can be added at the time of submission. That person can complete many actions and be the main point of contact but cannot submit formal requests.
Before completing the IRB application form, you must know: • The identity of all of the investigators who will be working on the project; • Who will be recruited to participate and how they will be recruited; • Where the research will be conducted; • What data will be collected and what will happen to that data; • How
Under 45 CFR 46.103, the IRB must review and approve all non-exempt human subject research. Failure to obtain IRB approval before conducting research could result in the researcher being unable to use data and other information collected through the research process.
This form is used by institutions or organizations operating IRBs that review: Research involving human subjects conducted or supported by the Department of Health and Human Services, or other federal departments or agencies that apply the Federal Policy for the Protection of Human Subjects to such research; and/or.
Continuing review provides the IRB with an opportunity to determine whether there is any new information that should be considered to represent such a significant new finding and therefore be communicated to subjects who have already enrolled in the research (e.g., important new toxicity information or new adverse

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The NSU-IRB Submission Form for Continuing Review is a document used to request ongoing approval for research studies that are already under the oversight of the Institutional Review Board (IRB). It allows researchers to provide updates on the progress of the study, any changes to the research protocol, and information about participant safety.
Researchers who are conducting studies that have been previously approved by the IRB and that need continued approval for further research activities are required to file the NSU-IRB Submission Form for Continuing Review.
To fill out the NSU-IRB Submission Form for Continuing Review, researchers should provide accurate and thorough information regarding the current status of the research, including recruitment status, participant demographics, any adverse events, changes to the protocol, and plans for future research activities. It may also require attaching supporting documents.
The purpose of the NSU-IRB Submission Form for Continuing Review is to ensure that ongoing research continues to meet ethical standards and that participant welfare is safeguarded. It serves as a mechanism for the IRB to evaluate the study's progress and compliance with approved research protocols.
The NSU-IRB Submission Form for Continuing Review must report information such as updates on participant enrollment, adverse events or issues encountered, changes to the research protocol or informed consent process, and any new pertinent information that may affect the study's risk-benefit assessment.
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