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PADDI Sleep Substudy: Statistical Analysis Plan This is the second version of the SAP and was written after the data had been deidentified as regards to treatment and with further analysis added.General

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How to fill out change of study design

01

Review the current study design and identify the areas that need change.

02

Consult relevant stakeholders, including research team members and ethics committees, to discuss necessary modifications.

03

Draft a formal request or proposal detailing the reasons for the change and the specific alterations to be made.

04

Complete any required forms or documents as stipulated by your institution or governing body for study modifications.

05

Make sure to include a clear timeline for the proposed changes and their expected impacts on the study outcomes.

06

Submit the change of study design request through the appropriate channels for approval.

07

Follow up on the request to ensure it is processed in a timely manner.

Who needs change of study design?

01

Any researchers or institutions conducting a study that requires modifications to its original design.

02

Study coordinators who encounter unforeseen circumstances affecting the study’s methodology.

03

Ethics review boards that need to ensure compliance with updated research protocols.

04

Funding bodies requiring updated project outlines due to substantial changes in the study design.

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What is change of study design?

Change of study design refers to any modification or alteration made to the original framework of a research study, which can include changes in methodology, objectives, or participant criteria.

Who is required to file change of study design?

Researchers or institutions conducting studies that require oversight, such as clinical trials and regulated research studies, are typically required to file a change of study design.

How to fill out change of study design?

To fill out a change of study design, you must complete the designated form provided by the overseeing regulatory body, ensuring all necessary details about the changes are accurately documented.

What is the purpose of change of study design?

The purpose of change of study design is to ensure that any significant modifications to a study are reviewed for compliance, safety, and ethical considerations, maintaining the integrity of the research.

What information must be reported on change of study design?

Information that must be reported includes details of the changes, reasons for the changes, any implications on the study’s outcomes, and adjustments to the study protocol.

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