Clinical Study Start-Up: Overview of the Process and Expected Challenges
Journal Title: Journal of Clinical and Medical Research - Year 2020, Vol 2, Issue 2
Abstract
Start-up phase is the base of any project at any type of business, and CROs are not an exception. Initially, the emphasis was concentrated on conducting the study, with little attention paid to study start-ups (SSUs), but as stakeholders become more and more aware that the effectiveness of SSU processes is directly related to shorter clinical periods, interest in this opportunity is growing. SSU covers a lot of activities starting from sites identification and completing the enrollment of the first patient - in between this includes site selection and pre-study visits, trial documents submission to competent authorities, contract and budget execution, vendors approval and setup, site activation, site initiation visits and, at last, enrolling the first patient. Each step has multiple components and requires utmost care and attention to minimize the likelihood of study delivery delays from the beginning.
Authors and Affiliations
Olena Barabash*
Keywords
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- EP ID EP708387
- DOI https://doi.org/10.37191/Mapsci-2582-4333-2(2)-031
- Views 62
- Downloads 0
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