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FORM 2.1 APPLICATION FOR REVIEWER Protocol NumberSponsor Protocol Numerate of SubmissionType of SubmissionInitial ReviewContinuing ReviewResubmissionProtocol TerminationProtocol AmendmentFinal ReportTitlePrincipal
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How to fill out substantial amendment notification form

01
Obtain the substantial amendment notification form from the appropriate regulatory authority.
02
Fill out the form completely and accurately, providing all required information such as study details, rationale for amendment, and impact on study conduct.
03
Submit the completed form to the regulatory authority for review and approval.
04
Await notification from the regulatory authority regarding approval or any additional requirements.

Who needs substantial amendment notification form?

01
Researchers conducting clinical trials or studies that have undergone substantial changes requiring notification to the regulatory authority.

What is Substantial Amendment Notification (Cf. Section 3.7.b ... Form?

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It is a form used to notify of significant changes or modifications to a previously approved document or plan.
Any individual or organization making substantial changes to a previously approved document or plan is required to file the form.
The form typically requires detailed information about the changes being made, the reasons for the changes, and any potential impact on stakeholders.
The purpose of the form is to ensure transparency and accountability around significant changes to approved plans or documents.
The form typically requires information about the changes being made, the reasons for the changes, and any potential impact on stakeholders.
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