Last Updated: 02/10/11
About the Branch Chief
Gary L. Smith was appointed Branch Chief in January 2011, following the untimely death of Joan Mauer in October, 2010. Gary received the degree of Master in General Administration with concentration in Healthcare Administration from the University of Maryland, and a Bachelor of Science in Medical Technology from the University of Maryland, School of Medicine. More…
Clinical Trials Monitoring Branch (CTMB)
The CTMB is responsible for on-site auditing of all clinical trials sponsored by the Cancer Therapy Evaluation Program (CTEP) / Division of Cancer Treatment (DCTD), NCI and the auditing of selected cancer prevention trials sponsored by the Division of Cancer Prevention (DCP). This includes all trials conducted by the Cooperative Groups/CCOPs and studies conducted at Cancer Centers or other individual institutions which utilize DCTD, NCI-sponsored investigational agents.
CTMB is responsible for oversight of the Clinical Trials Monitoring Service (CTMS). The CTMS contractor presently is Theradex ®.
The Branch sets guidelines and standards for the conduct of clinical trials in order to assure data quality and compliance with regulatory requirements for clinical research.
CTMB staff members are considered expert resources for dealing with and handling inquiries to problems by both intramural and extramural staff in regards to FDA regulations (http://www.fda.gov/oc/gcp/default.htm) and HHS Office for Human Research Protections (http://www.hhs.gov/ohrp/) regulations.
CTMB functions include:
- Continually updating the CTMB guidelines and criteria for ensuring acceptable audits and conducting further investigations when warranted.
- Managing an electronic audit report submission system for oversight and review of preliminary audit findings, final audit reports and follow-up responses for final approval.
- Maintaining and continually updating the automated CTMB Audit Information System (CTMB-AIS) which tracks approximately 1,500 Cooperative Groups/CCOPs audits annually.
- Ensuring timely submission of reports and follow-up responses/corrective action plans in response to audit findings.
- Attending scheduled audits by the Cooperative Groups, particularly when there are concerns of poor data quality or scientific misconduct.
- Reviewing and approving requests for additions or changes to the Cooperative Groups/CCOPs rosters of participating institutions through the CTMB-AIS.
- Conducting annual reviews of Cooperative Group rosters and auditing activities of participating institutions to ensure consistency between the CTMB-AIS roster and each Group roster.
Cancer Center / Single Institution / Special Response Audits
- Managing and coordinating the audit process of Cancer Centers conducting clinical trials using DCTD/NCI-sponsored investigational agents.
- Scheduling, selecting patient cases, attending and participating in Cancer Center and single institution audits.
- Evaluating site visit reports of the Cancer Center's and single institution's audits, recommending actions or sanction when necessary.
- Arranging and participating in Special Response audits for development of new agents in a specific disease site.
- Directing and overseeing all the Clinical Trials Monitoring Service (CTMS) assignments which consist of review and approval for data management and audits of Phase I and selected Phase 2 trials.
- Reviewing protocols and informed consent forms of clinical trials sponsored by the DCTD/NCI prior to their implementation to provide comments to appropriate CTEP staff at Protocol Review Committee meetings.
- Regularly review and have input on approving changes/additions to protocol amendments and informed consent forms of ongoing clinical trials.
- Knowledgeable with the FDA regulations, Good Clinical Practices (GCP), NCI policies, and human subjects regulations.
- Frequently responding to inquiries by NCI clinical investigators dealing with trial compliance, Institutional Review Board procedures, informed consent, and broad regulatory compliance issues.
- Liaison with the Office of Research Integrity (ORI), Office for Human Research Protections (OHRP), and Food and Drug Administration (FDA).