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INSTITUTIONAL REVIEW BOARD (IRB)CALIFORNIA STATE UNIVERSITY, SAN BERNARDINOHuman Subjects Protocol Change/Modification/Amendment Format:IRB NUMBER:EMAIL ADDRESS(S):REVIEW CATEGORY: EXEMPTEXPEDITED
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How to fill out human subjects protocol changemodificationamendment

01
To fill out a human subjects protocol changemodificationamendment, follow these steps:
02
Start by reviewing the original human subjects protocol and identifying the specific modifications or amendments that need to be made.
03
Clearly outline the requested changes in a separate document, including the rationale or justification for each change.
04
Include any new or updated consent forms, questionnaires, or other materials that will be used as part of the amended protocol.
05
Fill out the required forms provided by the appropriate governing body or institution, ensuring all necessary fields are completed accurately and comprehensively.
06
Attach any supporting documentation or additional information that may be required, such as revised research methodologies or updated risk assessments.
07
Seek internal review and approval from the relevant ethics committee or institutional review board before submitting the amendment.
08
Submit the completed amendment form and supporting materials to the appropriate authority, following their specific submission guidelines and timelines.
09
Keep copies of all submitted documents for your records and be prepared to address any possible follow-up questions or requests for further clarification.

Who needs human subjects protocol changemodificationamendment?

01
Researchers and investigators who are conducting studies or experiments involving human subjects may need to fill out a human subjects protocol changemodificationamendment.
02
This includes individuals or organizations that have already received approval for their original protocol and now need to make modifications or amendments to the study design, procedures, or participant information.
03
Compliance with ethical guidelines and regulations usually mandates the completion of a formal amendment to ensure that any changes being made do not pose additional risks or harm to the human subjects involved.

What is Human Subjects Protocol Change/Modification/Amendment - irb csusb Form?

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Human subjects protocol changemodificationamendment refers to any changes or modifications made to a research study involving human subjects.
Principal investigators or researchers conducting studies with human subjects are required to file a protocol changemodificationamendment.
To fill out a human subjects protocol changemodificationamendment, the principal investigator must provide details of the changes made to the study protocol and submit any required supporting documentation.
The purpose of a human subjects protocol changemodificationamendment is to ensure that any changes to the study protocol are reviewed and approved to protect the rights and welfare of human subjects.
The information reported on a human subjects protocol changemodificationamendment may include changes to study procedures, recruitment methods, informed consent documents, or any other modifications to the original study protocol.
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