The Office for Human Subject Protection has recently updated their Study Team Member Onboarding & Training Tool and Informed Consent Observation Tool.
The Study Team Member Onboarding & Training Tool was created to facilitate onboarding and training of new study team members; it provides suggestions for general orientation tasks, research-related training, systems access and training, and protocol-specific onboarding. Updated examples of how the training tool might be utilized for generic biomedical and social-behavioral research support positions (e.g., study coordinators, research assistants) are also available for your reference.
The Informed Consent Observation Tool was created to support the assessment of study team member proficiency in facilitating informed consent discussions for the purposes of training, performance evaluation, and professional development.
Both the onboarding/training and observation tools are fully customizable and should be modified to suit the study team’s needs based on applicable regulations, policies, study-specific components, roles/responsibilities, and/or prior experience.
For questions related to the onboarding/training and observation tool, contact Kelly Unsworth.
Review additional information in OHSP’s Guideline for Training Research Personnel
Review additional training resources available through OHSP
new clinical research Study Start-Up Resources
The Clinical & Translational Science Institute’s (CTSI) Office of Clinical Research has recently developed a URMC Clinical Research Study Start-Up Manual. The manual provides best practices for study start-up, including details related to the Confidential Disclosure Agreement (CDA) process, feasibility assessment and site selection process, regulatory and financial considerations, and study activation. For questions related to the start-up manual, contact the Office of Clinical Research.
Learn more about services available through the Office of Clinical Research