The CRRO has a number of tools, templated documents, and guidance available for the research community to use. These resources are optional but are generally recommended to help teams meet protocol adherence and regulatory standards.
Study Documentation Tools
Documents in template form are available for managing participant-related and regulatory-related documentation as part of ICH GCP and general best practices. Further guidance on Study Documentation is also available in the SOP specifically on Essential Research Documents.
Self-Assessment Review Tools
Checklists are available for teams to complete their own internal review on documentation and adherence. Those wishing for additional information are encouraged to to review the SOP specifically on Quality Management.
Clinical Research Reference Guide
Developed by the Research Professionals Network, this provides new and existing research team members with key information about research conducted at Boston University Medical Campus and Boston Medical Center.
Brochures for Participating in Research
A set of brochures is available to provide to prospective and enrolled participants as well as community members and patients in general.
Study teams wishing to use electronic consents either for in-person or remote consenting are recommended to review this set of guidance. These documents include an overview providing general information and specific REDCap guidance on Exempt and Non-Exempt research. Regulatory-specific guidance on implementing eConsent is also available by requesting a CRRO consultation. Additional REDCap guidance is available by requesting a REDCap consultation.
Institutional Standard Operating Procedures (SOPs)
Covering a wide range of topics, the SOPs include guidance on how to complete some of the daily activities of a research team and also address overarching structural activities. Additional information about SOPs are available monthly in the Clinical Research Times newsletter column titled “Spotlight on SOPs”.