Site readiness.
Find the gaps, organize your priorities, and build a practical action plan.
Start with your team.
YOUR NEXT MOVES
A plan you can act on.
6 priority areas need confirmation. Address these with an experienced investigator or operational adviser before committing to study activities.
An engaged investigator has time for study oversight.
Agree investigator availability, responsibilities, and escalation cover.
Coordinator coverage and backup roles are defined.
Map primary and backup staff to the expected study workload.
Role-appropriate training is documented.
Check training records against the protocol, sponsor expectations, and applicable requirements.
Clinical decisions and safety concerns have a clear escalation path.
Define who makes clinical decisions and how urgent concerns reach them.
Private consent and examination spaces are available.
Walk through consent, examinations, records access, and participant privacy.
Storage and accountability can meet the planned study’s requirements.
Confirm IP storage, access, temperature monitoring, and accountability needs.
Sample collection, processing, and shipping workflows are feasible.
Verify facilities, staff capability, equipment, and courier timing.
Records can be accessed securely by authorized people.
Document access controls, backups, auditability, and study record retention.
Core procedures reflect how the team actually works.
Review consent, safety, data, IP, deviations, and escalation procedures.
Study approvals and authorization are tracked before activation.
Establish a study-specific activation checklist for required approvals.
Study responsibilities and training will be recorded before tasks begin.
Create a responsibility matrix and study-specific training workflow.
Quality review and corrective action have named owners.
Define what is reviewed, how often, and who follows up.
Patient access is supported by current, study-relevant information.
Validate the population against actual criteria without exporting identifiable records.
Recruitment estimates reflect staff and visit capacity.
Build a funnel-based forecast and compare it with visit capacity.
The operating plan accounts for delayed receipts.
Model monthly cash needs separately from contracted revenue.
The first studies fit the team’s skills and facilities.
Review therapeutic fit, procedures, visits, and competing commitments.
Scope: general U.S. outpatient site planning. Applicable requirements vary by jurisdiction, study design, protocol, and sponsor. Not a certification or a substitute for qualified review. Checklist version: November 2026.
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