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CLINICAL PROTOCOL Amendment 3 Version Date: 19 April 2017 Protocol Amendment 2 Version Date: 12 August 2016 Protocol Amendment 1 Version Date: 14 March 2016 Original Final Version Date: 16 February
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How to fill out protocol amendments - spirit

01
Review the existing protocol to identify the amendments required.
02
Prepare a cover letter addressing the purpose of the amendments and any changes being made.
03
Create a table summarizing each amendment, including the section/page number, the current wording, and the proposed changes.
04
Clearly define the rationale for each amendment in a separate section.
05
Obtain necessary approvals from ethics committees or regulatory bodies, if applicable.
06
Update any relevant study documentation, such as informed consent forms or study manuals, to reflect the amendments.
07
Distribute the amended protocol to all relevant parties, ensuring everyone is aware of the changes.
08
Archive the old version of the protocol and maintain a record of all amendments made.

Who needs protocol amendments - spirit?

01
Researchers conducting clinical trials or studies requiring a protocol can benefit from protocol amendments.
02
Ethics committees and regulatory bodies may also require protocol amendments to ensure compliance and ethical considerations.
03
Sponsors or funding organizations may need protocol amendments to reflect changes in study design, endpoints, or procedures.
04
Participants or subjects involved in the study may need to be informed about any amendments that could affect their participation or safety.
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Protocol amendments - spirit refer to changes or updates made to the original protocol document that outlines the objectives, design, methodology, and statistical considerations of a clinical trial.
The Principal Investigator or sponsor of the clinical trial is required to file protocol amendments - spirit.
Protocol amendments - spirit can be filled out by accessing the protocol document, making the necessary changes, and submitting the updated version to the appropriate regulatory body.
The purpose of protocol amendments - spirit is to improve the clarity, transparency, and accuracy of the clinical trial protocol, as well as ensure that any changes made are properly documented and communicated.
Protocol amendments - spirit must include details on the specific changes made to the protocol document, the reasons for these changes, and the potential impact on the study participants and trial outcomes.
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