Researchers can receive assistance with IRB application preparation including: development of data safety monitoring plans (DSMPs), writing and editing of consent forms, fulfilling of HIPAA requirements, etc. Assistance with study design, statistical issues, and development of forms is also available through referral to experts within CTSI.
Assistance is also available for study implementation, including questions about regulations, policies, and guidelines to help ensure effective processes related to documentation, consenting, eligibility determination, AE monitoring/reporting, etc.
To schedule a consultation, contact the Clinical Research Resources Office by completing the CRRO Service Request form.
In-Person Training Sessions
The CRRO provides a range of training opportunities for investigators at all levels. For a list of specific trainings, click here. Training options include customized workshops or presentations based on the needs of particular study teams or departments.
Good Clinical Practice (GCP) Training
At BMC and BUMC, training on good clinical practice (GCP) is required for any investigator who is involved in the conduct of a clinical trial (per the NIH definition). A record of completion of GCP training will be maintained within the Collaborative Institutional Training Initiative (CITI) system—the training platform required by BMC and BUMC for meeting the basic human subjects protection training requirements—and reflected within INSPIR. Training can be completed in one of two ways:
- Take the GCP course within the BMC/BUMC web-based CITI training, an option for any BMC or BUMC investigator. For more details on registering with CITI, see here.
- Take one of two in-person trainings offered by the CRRO that satisfy the GCP training requirement: Fundamentals in the Conduct of Clinical Research or Principal Investigator Role
GCP training for those conducting clinical trials will need to be renewed every three years.