Clinical Trials Monitoring Branch (CTMB)

About CTMB

The Clinical Trials Monitoring Branch (CTMB) sets guidelines and standards for the conduct of NCI-sponsored clinical trials to ensure that sites conducting clinical research comply with all federal regulatory requirements and produce high-quality data to improve outcomes and quality of life for patients undergoing cancer treatment.

CTMB staff members are expert resources for clinical trial staff within NCI and across America's nation-wide cancer research networks, providing support and education to healthcare professionals and working to assure data integrity, patient safety, and protocol compliance.

CTMB is responsible for quality assurance oversight, which includes auditing and monitoring of all CTEP-sponsored clinical trials as well as auditing of selected cancer prevention trials sponsored by the Division of Cancer Prevention (DCP).

Key CTMB staff responsibilities include:

For NCI Clinical Trial Network Groups

• Maintaining and improving the electronic reports submission system and the automated Audit Information System, CTMB-AIS, to efficiently track audits across the various Networks.
• Ensuring timely submission of reports and corrective action plans.
• Attending Network Group audits, particularly when there are concerns of poor data quality or scientific misconduct, and conducting further investigations when warranted.
• Reviewing and approving changes to participating institution rosters in the CTMB-AIS, annually reviewing for consistency with Group rosters.

Single Institutions and Special Response Audits

• Scheduling, selecting patient cases, attending and participating in monitoring visits, evaluating site reports, and recommending actions or sanctions if needed.
• Arranging and participating in Special Response audits for development of new agents in a specific disease site. 

CTMB Resources

CTEP CTMB Staff Directory