By Beth Harper, Chief Learning Officer, Pro-ficiency
A focus on evaluating protocol-specific training already conducted at a research site could hold a key to better focusing site initiation visits (SIVs) on critical factors and reducing the amount of time spend on these meetings.
The SIV is used to confirm that a site has hit several milestones needed to be ready to start enrolling patients. These milestones include:
- All staff have been property trained and qualified;
- Any necessary equipment—from e-diaries and electronic data capture (EDC) systems to special equipment like ECGs—is in place and working properly;
- Staff that must use the equipment has appropriate access and is able to use it correctly; and
- The study drug is on-site, properly documented and stored, and in sufficient numbers for the expected number of patients.
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