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FORM APPROVED: OMB NO. 06940135 U.S. DEPARTMENT OF COMMERCE Bureau of Industry and Security Date Received (Leave Blank) U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards
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How to fill out additional protocol report form:

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Begin by reviewing the instructions provided with the form. This will give you a clear understanding of the information required and any specific guidelines for filling out the form correctly.
02
Identify the purpose of the report form. Determine why you are required to fill it out and what information needs to be documented. This will help you gather the necessary data and ensure you provide accurate details.
03
Start by filling out the basic information section of the form. This typically includes your name, contact information, and any other relevant identification details. Make sure to enter the information accurately and legibly.
04
Proceed to the main body of the form, where you will be asked to provide specific information related to the protocol being reported. This may include details about the study or research being conducted, any changes or deviations from the original protocol, and any adverse events or side effects that have occurred.
05
Take your time to fill out each section thoroughly, ensuring you provide all required information in a clear and concise manner. Use appropriate language and avoid any vague or ambiguous statements.
06
If any supporting documents are required, such as laboratory results or participant consent forms, make sure to attach them securely to the form. Label each attachment clearly and ensure they are easily identifiable.
07
Once you have completed filling out the form, review it carefully to check for any errors or missing information. Correct any mistakes or omissions before submitting the report.
08
Finally, ensure you submit the completed additional protocol report form to the designated recipient or authority within the specified timeframe. Follow any specific submission instructions provided to ensure your report is received and processed promptly.

Who needs additional protocol report form?

01
Researchers involved in a study or research project that requires additional protocols beyond the original approved protocol may need to fill out an additional protocol report form.
02
Institutions or organizations overseeing the study or research project may require researchers to submit additional protocol report forms for proper documentation and compliance purposes.
03
Regulatory bodies or ethics committees responsible for monitoring and approving research activities may request researchers to provide additional protocol report forms to ensure transparency, accountability, and adherence to established protocols and guidelines.
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