Glossary
Study start-up
Everything between choosing sites and enrolling the first patient: site identification and selection, contracts, budgets, IRB review, documents and activation.
What does Study start-up mean in clinical research?
Study start-up covers site identification, site selection and the work needed to activate each site: confidentiality agreements, feasibility, contract and budget negotiation, IRB approval, essential documents and protocol training. In a Tufts CSDD survey of more than 400 pharmaceutical, biotech and CRO companies, start-up averaged 5 to 6 months in total, and cycle times were faster for repeat sites than for new ones.[1]
The same survey found that CROs completed all site-related start-up activities 6 to 11 weeks faster than sponsors.[1] Every month in start-up is a month without enrollment, which is why CTTI recommends moving recruitment planning upstream, in parallel with trial design.[2]
Practical note: recruitment tools add their own start-up steps. Run them in parallel with contracts and budget rather than after:
- Security review and a signed BAA.
- EHR access approval and interface setup.
- IRB review of outreach scripts, texts and AI disclosure language.
- Workflow configuration with the coordinators. Implementation shows how Bond's setup runs.
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.CTTI Recommendations: Planning for Successful Trial Recruitment · Clinical Trials Transformation Initiative, 2018