Study Start-Up and Site Activation

Evaluate site patient population against protocol inclusion and exclusion criteria using medical records, registries, and referral networks.

Analyze the competitive study landscape at the site level, assess therapeutic area saturation, and apply a structured accept/defer/decline framework when studies compete for the same resources and patients.

Complete feasibility questionnaires with honest, data-supported answers and understand the purpose and obligations of confidential disclosure agreements.

Learn the structure of clinical trial budgets including per-patient payments, screen failure fees, procedure costs, and overhead calculations.

Understand the clinical trial agreement negotiation process and the CRC's role in supporting contract discussions with operational cost intelligence.

Track study budgets, manage invoicing milestones, and flag financial discrepancies to site management throughout the study lifecycle.

Understand the significance and legal implications of FDA Form 1572, including the investigator commitments it represents.

Prepare a complete IRB/IEC initial submission package including all required supporting documentation, and implement a tracking system to prevent common return reasons.

Differentiate the submission processes for central IRB review, local IRB review, and institutional-level approvals, and navigate the practical workflow differences that affect your start-up timeline.

Navigate regulatory authority notification requirements and site-specific institutional approvals needed before study activation.

Compile a complete set of pre-study essential records as specified in ICH E6(R3) Appendix C.

Verify the currency, completeness, and accuracy of investigator qualifications documentation including CVs, medical licenses, GCP training certificates, and delegation of authority logs.

Collect and verify the laboratory documentation required for study activation, including CLIA/CAP certifications, normal reference ranges, laboratory director credentials, and central laboratory setup records.

Manage the receipt, version verification, and tracking of sponsor-provided documents including the protocol, Investigator's Brochure, IP handling instructions, and study-specific materials required for site activation.

Prepare a comprehensive SIV readiness package including regulatory binder completion status, team availability confirmations, physical site preparation, and a pre-SIV open items communication to the CRA.

Identify the six critical information domains that must be captured during the SIV, formulate operational questions the CRA may not cover unprompted, and document the visit for team reference.

Create and execute a post-SIV action item tracker that ensures the site achieves activation within sponsor timelines.

Execute a comprehensive final activation checklist verifying every regulatory, operational, and logistical requirement before first enrollment.

Configure and verify access to all study-required electronic systems for all authorized site personnel.

Build visit-specific workflow templates, pre-approve standing orders, establish supply management systems, and create an internal study reference guide before the first participant arrives.

Verify that every team member, system, supply, and workflow is genuinely ready before the first participant encounter -- and make the go/no-go decision with confidence.

Walk through the complete first enrollment process from participant identification through screening, consent, eligibility confirmation, randomization, and first study visit procedures.