Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
PayerTrial Design Stage
Published Date: April 29, 2025
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Helpful Terms and Definitions
*This list is not exhaustive, nor does CTTI officially endorse the resources created by other organizations.
Draft Protocol
Establish a consistent communication model with clear expectations across sponsors and sites to support alignment and prevent operational gaps during execution
Questions To Ask
- Can the study be implemented at the site as designed, and what support is required?
- How does the study design impact patient enrollment and retention?
- What operational challenges are likely to arise, and how can they be addressed proactively?
- Are communication pathways between sponsors and sites clearly defined and consistent?
Why involve investigators and sites now?
At the draft protocol stage, engagement focuses on refining execution details and ensuring sites are prepared to operationalize the study.
Investigators and site teams provide critical input to:
- Validate enrollment assumptions and patient flow
- Identify operational challenges before study start
- Evaluate feasibility of procedures, schedules, and monitoring requirements
- Assess readiness for new technologies or study processes
Early engagement and site selection are not separate processes—they work together to ensure:
- A realistic and patient-centered protocol
- Strong investigator engagement and site readiness
- Improved enrollment and retention
- Fewer protocol deviations
- More consistent execution across sites
Engage early → refine the design → identify the right sites → prepare sites for success
Recommended topics and methods of engagement
| Protocol Element | Recommended Engagement |
|---|---|
| Study Design | Engage investigators who treat the target population (not only high-volume trialists) to understand real-world feasibility and enrollment impact |
| Endpoints | Use advisory boards including experienced investigators and clinicians working with underrepresented populations |
| Enrollment / Withdrawal
Inclusion / Exclusion |
Gather input from investigators and coordinators actively managing eligible patients |
| Study Agent & Control | Engage clinical staff (including pharmacists where applicable) on preparation, storage, and administration |
| Study Schedule, Procedures & Evaluations | Involve both investigators and coordinators to assess workflow feasibility and burden |
| Clinical Monitoring | Engage coordinators who manage source documentation, queries, and monitoring interactions |
| Informed Consent | Work with sites to ensure processes are feasible and appropriate for the patient population |
| Ethics / Protection of Human Subjects | Use steering committees or advisory discussions to address ethical considerations across site roles |
Example Process for Draft Protocol Engagement
Obtaining and Integrating Site & Investigator Feedback During Protocol Finalization (PDF)
Refine the Design
- Sponsors streamline endpoints and procedures
- Sites review the Schedule of Events to ensure feasibility in a clinical setting
Enable site readiness
Site Initiation Visit (SIV) as a working session
- Use kickoff meetings as collaborative discussions rather than one-way training
- Encourage open identification of risks and operational challenges
Feasibility walkthrough (recommended)
- Have site staff walk through a full patient visit (check-in → assessments → discharge)
- Identify workflow gaps, patient burden, and operational risks
Who should be involved?
Include a broad representation of site personnel:
- Investigators and sub-investigators
- Study coordinators
- Site operations staff
- Pharmacy or lab personnel (as relevant)
Each role provides a different perspective on execution, helping identify issues before they result in protocol deviations.
What aspects of the draft protocol should they inform?
At this stage, the focus shifts from redesign to detailed validation and implementation readiness:
- Study design feasibility in practice
- Enrollment and retention assumptions
- Study schedule and workflow integration
- Operational burden and site capacity
- Informed consent feasibility and clarity
- Monitoring and data collection processes
- Technology implementation and usability
- Risk areas that could lead to protocol deviations