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NORTH Ethics Committee for Clinical Studies
6.2 Review of Protocol Amendments SOP Code: SOP/12/V1.2
Effective date : 07/11/2017-Page no. 1 of 8Title: Review of Protocol Amendments SOP Code: SOP/12/V1.2Effective
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How to fill out management of protocol submissions

How to fill out management of protocol submissions
01
Step 1: Gather all necessary information and documents related to the protocol submission.
02
Step 2: Review the guidelines and requirements provided by the protocol management system.
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Step 3: Create an account in the protocol management system if required.
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Step 4: Log in to the protocol management system.
05
Step 5: Navigate to the 'Protocol Submission' or similar section.
06
Step 6: Fill out the required fields with accurate and complete information.
07
Step 7: Upload any necessary documents or attachments as specified.
08
Step 8: Review the filled-out form and documents for any errors or missing information.
09
Step 9: Submit the protocol submission by clicking on the 'Submit' or similar button.
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Step 10: Wait for confirmation or feedback from the protocol management system.
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Step 11: Follow up on any additional requirements or actions requested by the system or reviewers.
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Step 12: Maintain communication with the protocol management system throughout the submission process.
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Step 13: Monitor the status of the protocol submission until a final decision is reached.
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Step 14: If approved, proceed with the next steps outlined by the protocol management system. If rejected, evaluate the feedback and consider making necessary revisions before resubmitting.
Who needs management of protocol submissions?
01
Researchers and scientists who are conducting studies or experiments that require protocol submissions.
02
Institutions and organizations that have established protocols and procedures for research or experimentation.
03
Regulatory bodies and ethics committees responsible for reviewing and approving protocols for research or studies involving human or animal subjects.
04
Government agencies or departments that oversee certain areas of research or experimentation.
05
Academic institutions or universities that have specific guidelines and processes for protocol submissions.
06
Companies or industries involved in research and development activities.
07
Healthcare providers or medical professionals involved in clinical trials or medical research.
08
Any individual or entity involved in research or experimental activities that require adherence to specific protocols.
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What is management of protocol submissions?
Management of protocol submissions is the process of submitting and overseeing protocols for various procedures or studies.
Who is required to file management of protocol submissions?
Researchers, institutions, or organizations conducting studies or procedures that require protocols are required to file management of protocol submissions.
How to fill out management of protocol submissions?
Management of protocol submissions are typically filled out online through a designated platform or system provided by regulatory bodies.
What is the purpose of management of protocol submissions?
The purpose of management of protocol submissions is to ensure that research or procedures are conducted ethically and in compliance with regulations.
What information must be reported on management of protocol submissions?
Information such as study objectives, methods, expected outcomes, potential risks, and procedures for participant consent must be reported on management of protocol submissions.
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