Departments

Study Design and Feasibility:

• Helps refine hypotheses, study aims, and outcomes, and planned procedures appropriate to clinical conduct.
• Conducts feasibility analyses, including ease-of-recruitment, safety, ethics, financial and material resource availability, study-specific training, equipment and expertise, and other potential barriers.
• Provides opportunities to engage with communities, the Community Advisory Board, and patient advocacy groups for input on relevant perspectives and priorities.

Biostatistical Support:

• Provides expert input on study design, sample size estimation/power calculations, and data analysis plans through dedicated biostatistical navigation sessions.

Regulatory Compliance:

• Ensures adherence to applicable federal, state, and department of health laws, University and IRB policies, and international Good Clinical Practice (GCP) standards during study design and conduct.
• Identifies regulatory challenges and provides solutions to address them; helps teams understand internal and external monitoring responsibilities to assure compliance, and to respond to monitoring or audit findings.

Recruitment and Equity:

• Engages with the CRSO Recruitment Specialist to provide comprehensive recruitment planning, advises on study design to optimize recruitment feasibility, and creates data-driven recruitment plans for the protocol.
• Creates advertising materials, manages ad placement, and leverages the Volunteer Repository and Call Center to conduct telephone prescreening and scheduling of volunteers on behalf of study teams.
• Achieves recruitment of study cohorts representative of relevant local, national, and disease-specific populations.

Education and Training:

• Provides training in protocol design, human subject protections, and translational science principles to strengthen scientific rigor.

Risk Management:

• Evaluates risks, anticipated adverse events, and participant burdens to minimize risk and create robust data safety monitoring plans.

Submitting a GCP-compliant protocol

By fostering collaboration among researchers, clinicians, context experts, and support staff, the Research Facilitation Office ensures that clinical research submitted to the IRB and scientific review committee at Rockefeller University achieves the highest standards of scientific excellence, safety, and ethical integrity.

After protocol submission, the RFO helps investigators get ready for study implementation, e.g., completing study registration at [www.clinicaltrials.gov](http://www.clinicaltrials.gov), setting up financial/petty cash accounts for participant compensation, creating compensation receipts, setting up data capture forms and workflows, finalizing prescreening with the recruitment team, completing just-in-time training with clinical applications, etc. Once these steps are completed, the RFO assists the investigator with a Study Initiation meeting with Nursing, Pharmacy, and other hospital services to make sure execution will go smoothly.

• Study Coordination: For Clinical Scholars whose labs’ staff do not include clinical research coordinators, the RFO will provide clinical coordinator support to assist with study conduct. This may include assisting with consenting and screening, visit scheduling, and documentation.
• Investigators who are not trainees and who do not have a clinical research coordinator among their staff may need to designate a research assistant or co-investigator from among their staff whom the RFO will assist with training. Depending on demand, the RFO may be able to provide limited coordinator support to non-trainee investigators.
• RFO trains all investigators to conduct internal monitoring to assure study integrity and compliance.

RFO staff train investigators in proper documentation of clinical research, identifying, documenting, and reporting adverse events, serious adverse events, unanticipated problems, deviations, and violations. In addition, self-study training resources for such reporting are available in the Investigators Manual.

• Recruitment core/Recruitment specialist – x8409
• Community engaged research core
• Clinical Research Officer/Research Participant Advocate – x8408