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Please note that assigned tasks in this document are an example and have to be adapted for individual trials. Trial specific tasks may be added for individual trials. *Please add additional columns
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How to fill out guideline study start-up to

01
To fill out the guideline study start-up form, follow these steps:
02
Start by entering the required study information such as the title, study ID, and principal investigator.
03
Fill in the study objectives and background information.
04
Provide details on the study design and methodology.
05
Specify the inclusion and exclusion criteria for participant selection.
06
Describe the recruitment process and any necessary documents for obtaining informed consent.
07
Outline the procedures for data collection and data management.
08
Include information on the statistical analysis plan and sample size calculation.
09
Document any potential risks or adverse events that may occur during the study.
10
Describe the plan for data monitoring and quality control.
11
Finally, ensure that all necessary signatures and approvals are obtained before submitting the completed guideline study start-up form.

Who needs guideline study start-up to?

01
The guideline study start-up form is required by researchers, study coordinators, and study sponsors involved in planning and initiating a research study.

What is Guideline: Study Start-up to SIV and Site Activation Form?

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