Study Start-Up (SSU) Process
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A Study Start-Up (SSU) Process is a clinical trial process.
- See: Study Closeout Process.
References
2023
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- A Study Start-Up (SSU) Process is a clinical trial process that involves the preparation and initiation of a study site for the conduct of a clinical trial. This process includes a variety of activities, such as regulatory submissions, site selection and qualification, and study initiation.
- It can involve preparing and submitting regulatory documents for approval from regulatory authorities.
- It can involve selecting and qualifying study sites, including assessing the capabilities of the site and the suitability of the patient population.
- It can involve developing study protocols and informed consent documents and training study personnel on study procedures and requirements.
- It can involve initiating and activating study sites, including initiating patient enrollment and monitoring the study's progress.
- Related terms: clinical trial management, site management, study coordination, regulatory affairs, clinical operations.
- A Study Start-Up (SSU) Process is a clinical trial process that involves the preparation and initiation of a study site for the conduct of a clinical trial. This process includes a variety of activities, such as regulatory submissions, site selection and qualification, and study initiation.