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This addendum modifies terms of the clinical trial agreement involving the Foundation for the Promotion of Health and Biomedical Research and other stakeholders.
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How to fill out addendum to clinical trial

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How to fill out addendum to clinical trial

01
Review the original clinical trial protocol to understand the background and purpose of the study.
02
Identify the sections of the protocol that need to be modified or updated.
03
Draft the changes to be made in the addendum, ensuring the language is clear and precise.
04
Consult with the Principal Investigator or study team members to review and approve the changes.
05
Submit the addendum to the Institutional Review Board (IRB) or Ethics Committee for review and approval.
06
Once approved, distribute the addendum to all relevant parties and update the trial documentation accordingly.

Who needs addendum to clinical trial?

01
Researchers conducting a clinical trial who need to make modifications or updates to the original protocol.
02
Institutional Review Boards (IRBs) or Ethics Committees responsible for reviewing and approving changes to clinical trial protocols.
03
Regulatory authorities who require documentation of any changes made during the course of a clinical trial.

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An addendum to a clinical trial is a document that provides additional information or modifications to the original clinical trial protocol.
Typically, the principal investigator or the sponsor of the clinical trial is required to file an addendum.
To fill out an addendum to a clinical trial, one must complete the designated forms, clearly outline the changes or additional information, and ensure compliance with regulatory guidelines.
The purpose of an addendum to a clinical trial is to ensure that any significant changes or updates to the clinical trial protocol are officially documented and communicated to regulatory authorities.
The addendum must report changes in study design, inclusion/exclusion criteria, safety information, or any other relevant updates that may impact the conduct or outcomes of the trial.
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