The CTMB is responsible for on-site monitoring of all clinical trials sponsored by the Cancer Therapy Evaluation Program, as well as monitoring select cancer prevention trials sponsored by the Division of Cancer Prevention (DCP). This includes all trials conducted by the Cooperative Groups, and studies conducted at the Cancer Centers or other individual institutions which utilize DCTD, NCI-sponsored investigational agents. The Branch is also responsible for setting 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://ohrp.osophs.dhhs.gov/) for regulations. Many inquiries deal with Institutional Review Board procedures, informed consent, and broad regulatory compliance issues.
Specifically, CTMB functions include:
- Managing the site visit monitoring process for all clinical trials using NCI-sponsored investigational drugs and biological response modifiers
- Setting criteria for acceptable site visit findings and conducing further investigations when warranted
- Evaluating site visit reports recommending actions or sanctions if necessary and implementing such actions when appropriate
- Providing information to all NCI clinical investigators regarding FDA regulations, NCI policies, procedures, and human subjects regulations.
|
