Glossary
Site activation
The point at which a selected site has finished contracts, budget, IRB approval and training, and the sponsor authorizes it to start enrolling participants.
What does Site activation mean in clinical research?
Site activation is the end point of study start-up: the moment a selected site is authorized to enroll. Tufts CSDD measures the start-up process from site identification through site activation.[1] Before activation, a site typically needs an executed contract and budget, IRB approval, its essential regulatory documents in place, and a site initiation visit or training on the protocol.
Activation is slow and hard to predict. In the CREST-2 trial, across 147 sites, the median time from site selection to authorization to randomize was 9.9 months, and the investigators did not identify factors associated with early activation.[2] Every month spent there is a month the site cannot enroll.
Practical note: use the time between selection and activation to prepare recruitment, not only paperwork. Getting outreach scripts into the IRB submission, and connecting records review while contracts are negotiated, lets the site contact candidates as soon as it is activated. See Implementation for how Bond's setup runs alongside start-up.
Sources
- 1.Assessing Study Start-up Practices, Performance, and Perceptions Among Sponsors and Contract Research Organizations · Therapeutic Innovation & Regulatory Science (Tufts CSDD), via PubMed, 2018
- 2.Factors Associated With Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial · Stroke (American Heart Association), via PubMed, 2017Quote: "For 147 sites, the median time between site selection to authorization to randomize was 9.9 months (interquartile range, 7.7, 12.4), and factors associated with early site activation were not identified."