The Clinical Research Operations and Management Branch (CROMB) has responsibility for assessing study risk, implementing data and safety monitoring oversight, tracking enrollment progress, and mitigating study related issues for the complete portfolio of NIAMS funded clinical trials and select human subjects observational studies with some level of risk (60-70 studies currently active in the managed portfolio). Specifically, this responsibility includes:
- Implementing NIH policies pertaining to clinical trials, in addition to being subject matter experts on Federal Policies for Protection of Human Subjects (Revised Common Rule) and FDA regulations.
- Assisting with questions and issues related to NIH Human Subjects System (HSS) and inclusion monitoring of women and minorities.
- Tracking NIAMS awardee compliance with clinicaltrials.gov registration and results reporting.
- Serving as point-of-contact for questions related to NIAMS Clinical Research Funding Opportunities.
- Advising Program Officers and prospective applicants on NIH clinical trial definition questions and clinical trial required FOA questions.
- Creating and updating all clinical trial related templates and guidelines for NIAMS grantees posted on the NIAMS Clinical Research webpage.
- Updating and maintaining all content for clinical trial related webpages on NIAMS website, including Clinical Trials in the Spotlight page.
- Educating, training, and disseminating information related to clinical trials through ongoing monthly Clinical Trial Crosscutting Group meetings for EP staff and monthly clinical research newsletter.
- Serving as NIAMS representative on trans-NIH committees and working groups: Clinical Trial Operations Working Group (CTOW); CTOW SOP Subcommittee; Inclusion Operating Procedures Working Group (IOPW).
- Working closely with NIAMS Program Staff, NIAMS grantees, and prospective applicants to advise on all questions related to clinical trial policies, funding opportunities, and implementation of clinical trials.
The CMT works closely with a Contract Research Organization (CRO), contracted by the NIAMS to provide logistical and operational support for the Institute’s clinical trial activities.