Research and Regulatory Consultations
Through consultations, the CRRO provides expert review and guidance for investigators and research staff. Consultations can be requested at any point during the life of a study and for any reason. Any member of a study team or research staff member may request a consultation. The IRB may request that the study team complete a consultation as part of their study submission review.
For simple questions, consultations can be completed over email but most will generally involve at least one meeting or more depending upon the complexity of the request. Researchers can also use the Zoom Office Hours for simple questions if a face-to-face conversation would be beneficial.
For investigators with funding or submission deadlines, it is recommended that consultations are requested early in the process to best meet those deadlines.
For brief or short discussions, drop in to a Zoom Office hour, Mondays 3–4pm.
To request a consultation, complete the Request CRRO Services form. A response can be expected within 5 business days.
Common Consultation Requests
- Required Review for Investigator-Initiated Clinical Trials
- Per HRPP policy 188.8.131.52, a study meeting the definition of a clinical trial that is initiated by the PI at Boston Medical Center or Boston University Medical Campus must complete a CRRO consultation prior to IRB review
- IRB Submissions
- Could include review of INSPIR application, protocol, consent, or any other study-specific document
- Could be an initial submission, CAPA submission, or protocol amendments
- Could include review of stipulations from any IRB review
- Study Implementation: either before or after start of recruitment and enrollment
- Recruitment plans either for feasibility or slower than expected enrollment rates
- Consenting processes
- Eligibility determinations and documentation
- Adverse events monitoring, assessing, and reporting
- General study documentation include setup of participant or regulatory files
- BMC SOP Guidance
- Implementation and completion of standards set in Quality Management and Research Team Competency SOPs
- General review and compliance recommendations for any SOP
- FDA Guidance
- Responsibilities of a Sponsor-Investigators holding an IND or IDE
- Review of initial or ongoing submissions
Depending on the type of consultation, benefits could include:
- Shortened IRB-review time
- More effective recruitment
- Fewer monitor or audit findings
For more information or questions, please contact us at firstname.lastname@example.org