While the definition varies across companies, study startup typically includes the process of identifying and qualifying sites, collecting essential documents at the study and site level, and submitting these documents for ethics approval.
Clinical trials that get off to a good start are more likely to be successful trials. The study startup phase is where this happens, and includes such activities as; investigator selection, regulatory and ethics submissions, site training and ends with the site initiation visits.
A study start-up (SSU) is a complex process that involves all the steps required to initiate a clinical trial. It can include:
- Building a budget
- Designing a protocol
- Signing a startup agreement
- Initiating documentation
- Customizing kits for sites
- Identifying and qualifying sites
- Collecting essential documents
- Submitting documents for ethics approval
The study start-up timeline can range from eight weeks to more than six months. One factor that influences the timeline is the ease of budget and contract negotiation and finalization.
A study start-up can also refer to a Site Initiation Visit (SIV). This is a meeting to discuss the new protocol before the research project is ready to screen and enroll potential patients.
The following process takes place after sponsor selects desired list of sites.
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