Clinical Trials Monitoring Service

Note--this synopsis follows a Sources Sought notice that was released on April 29, 2009 under Sources Sought Notice No. SS-ETSB-01008-03.



The purpose of this project is to assist the Cancer Therapy Evaluation Program (CTEP), NCI in fulfilling its responsibilities in meeting the regulations set forth by the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) as an Independent New Drug (IND) sponsor and funding agency by monitoring NCI sponsored clinical trials.





Major tasks required of the Contractor include the following:

1) Provide a protocol central patient registration, protocol patient data capture resource, and patient data quality control reviews for the Division of Cancer Treatment and Diagnosis (DCTD), NCI for clinical investigators conducting phase 0 (exploratory IND), phase 1 and selected phase 2 clinical trials.



2) Provide an on-site auditing resource for the DCTD to assure that contractors, grantees and other clinical investigators conducting phase 0, phase 1 and selected phase 2 clinical trials are in compliance with federal regulations, Good Clinical Practices (GCP), and NCI policies and procedures in order to verify submitted protocol patient data, assure the quality of submitted data, assure protocol compliance, and assure patient safety through proper reporting.



3) Assure the DCTD that the quality assurance programs of the Cooperative Groups, Community Clinical Oncology Program (CCOP) Research Bases, the Clinical Trials Support Unit (CTSU), and other selected multi-institutional consortiums are actively monitoring their NCI sponsored clinical studies in compliance with the AGuidelines for Monitoring of Clinical Trials for Cooperative Groups, CCOP Research Bases, and the Cancer Trials Support Unit. This shall be accomplished by attending as co-site visitors scheduled audits conducted by Cooperative Groups, Cancer Center CCOP Research Bases, and the CTSU or selected consortiums.



4) Assure the DCTD that all cancer centers, single institutions, multi-institutional consortiums and networks conducting clinical trials using DCTD sponsored trials are in compliance with Federal regulations, Good Clinical Practices (GCP), and NCI policies and procedures. This oversight shall be accomplished by on site auditing at these institutions at least once every three years.



5) Assure the DCTD that international groups/institutions who are collaborators in DCTD sponsored clinical trials are conducting these trials in accordance with Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) standards. This shall be accomplished through training and administrative support for quality assurance programs to ensure that GCP clinical trial and regulatory standards are met, particularly the protection of human subjects.



6) There are two options associated with the requirement:

A: Integration of NCI purchased Clinical Data Management System (CDMS) into Clinical Trials Monitoring Service processes, workflow and IT infrastructure.



B: Expand capability for conducting on-site audits to encompass the expanded scope of trials conducted under the auspices of the Cancer Trials Support Unit (CTSU). This expansion may also include clinical trials sponsored by other NCI Programs (SPORES, RAID and imaging).

Anticipated Period of Performance:



The anticipated base period of performance is May 1, 2010 April 30, 2011 with a one (1) year option period, May 1, 2011 April 30, 2012 and five (5), one (1) year award term option periods from May 1, 2012 April 30, 2017.



It is anticipated that the Request for Proposal (RFP) package will be available on or about June 25, 2009 with responses due within 30 calendar days following the actual date of issuance of the RFP. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. Full electronic copies will not be accepted, but portions of the proposal may be provided on disc. The reference number to be used for this announcement is: RFP N02-CM-01008-03. All correspondence must cite the reference number as provided.