Attachment21InformationtoOfferorsrevised091213.pdf

Attachment 21: Information to Offerors Page 1 of 7 RFP Number: N02CN35003-43

Cancer Prevention Clinical Trials Auditing and Informatics Support

INFORMATION TO OFFERORS

The National Cancer Institute, Division of Cancer Prevention (DCP) supports science that seeks to identify those at increased risk for developing cancer, as well as to identify and develop chemopreventive and other interventions to delay, arrest or reverse carcinogenesis at its earliest stages. The Division of Cancer Prevention manages a diverse portfolio of scientific and clinical initiatives in order to identify and prioritize potential cancer prevention agents, and to move these promising agents from pre-clinical testing to Phase 0, Phase I and Phase II clinical trials, and ultimately into large Phase III cancer prevention clinical trials.

The Division of Cancer Prevention oversees the systematic early clinical development of promising preventive agents through its Phase 0-I-II cancer prevention clinical trials program that includes the DCP Consortia for Early Phase Prevention Trials. First funded in 2003 with a core of six major medical research centers, the consortia program was renewed in 2012 with five of these major medical research centers chosen to lead studies.

Each Consortia organization is comprised of a funded research center known as the Consortium Lead Organization (CLO) and its affiliated Participating Organizations (PO). Requirements for data management, data reporting and auditing of Consortia studies, as well as the training and education needs of Consortia staff, will vary based on whether studies were funded under the 2003 or 2012 Consortia mechanism.

The systems and applications used for data collection, management and reporting include:

Oracle® Clinical-Remote Data Capture (OC-RDC) - Participant data from Consortia 2003 studies are collected and entered by the CLOs and/or POs into an Oracle Clinical –Remote Data Capture (OC-RDC) database system for centralized data management. These data are available as study-specific SAS data sets that are updated and posted monthly for CLO access on a secure data transfer website.

Minimum Data Set (MDS) - Participant data for each Consortia 2012 study are collected, entered and managed by each CLO, using a clinical data management system (CDMS) of the CLO’s choosing. Each CLO will electronically submit a subset of data from each clinical trial to DCP monthly as a standardized minimum data set (MDS) that will be loaded by DCP upon receipt into DCP’s central database (DESK).

The DCP Enterprise System Knowledgebase (DESK) is an Oracle® application managed by DCP that serves as the central database for management of administrative and selected participant-level data for DCP-sponsored clinical trials.

Data from DESK, OC-RDC and the MDS are to be used across all task areas as needed to fulfill the requirements of the contract.

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The following table defines the Contractor’s responsibilities for each Consortia mechanism.

Consortia 2003 Consortia Contract Period: 9/2003-9/2014

Data Collection System

Task Area 1 Data Management, Data Transfer and

Reporting

Task Area 2 Auditing and Data

Verification

Task Area 3 Education and Training

Oracle Clinical- Remote Data Capture (OC- RDC) V4.6 or later*

Database of record is hosted and managed by the Contractor

OC-RDC database maintenance for all studies

Auditing of clinical trial sites

Provide ad hoc and routine educational programs or materials based on identified needs of clinical trial sites

Perform quality assurance reviews of clinical trial data in OC- RDC, including discrepancy resolution

Data verification of OC-RDC data against source documents and CRFs

OC-RDC training

Provide monthly and ad hoc reports of data quality, timeliness, and clinical trial data including SAS datasets

Review of DCP Consortia Clinical Trials webpages

(http://prevention.cancer.g ov/clinicaltrials/manageme nt/consortia/2003)

Maintain the mechanisms for OC-RDC data transfer to DESK, and receipt and posting of clinical trial data received outside of OC-RDC

Development and review of Consortia 2003 SOPs

(http://prevention.cancer.g ov/clinicaltrials/manageme nt/consortia/2003)

Maintain DCP Collaboration Repository

(DCP-CR)

Provide HelpDesk Support

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Consortia 2012 Consortia Contract Period: 9/2012-9/2017

Data Collection System

Task Area 1 Data Management, Data Transfer and Reporting

Task Area 2 Auditing and Data

Verification

Task 3 Education and Training

CLO-specific clinical data management system

Database of record is managed by the

CLO

Review of study-related documents

(http://prevention.cancer.

gov/clinicaltrials/manage ment/consortia#y2012)

Auditing of clinical sites, including specimen inventory and tracking

Provide ad hoc and routine educational programs or materials based on identified needs of clinical trials sites

Develop and maintain mechanisms for transfer, reporting and storage of data and materials from DCP clinical trials

Data verification of MDS data and clinical site database of record against source documents

Review of DCP Consortia Clinical Trials webpages

(http://prevention.cancer.g ov/clinicaltrials/manageme nt/consortia)

Maintain DCP Collaboration Repository

(DCP-CR)

Development and review of Consortia 2012 SOPs

(http://prevention.cancer.g ov/clinicaltrials/manageme nt/consortia)

Provide HelpDesk support

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DCP Cancer Prevention Clinical Trials: Active

Consortia 2003: Active Clinical Trials

Document Number

Document Title Phase Lead Organization

MDA10-16-01 A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors

II M D Anderson Cancer Center

NWU06-8-01 Polyethylene Glycol for ACF Reduction and Biomarker Modulation in Individuals with CRC Risk

II Northwestern University

NWU09-13-02 Myo-Inositol Chemoprevention in Colitis- Associated Dysplasia

I/II Northwestern University

NWU09-4-03 Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine(MSC) and L SeMet in Adult Males

I Northwestern University

UAZ08-11-01 Clinical Study of Ursodeoxycholic Acid in Barrett's Patients

II Arizona Cancer Center

UAZ08-12-02 Phase I Dose-Finding Trial of Letrozole in Postmenopausal Women at High Risk for Breast Cancer

I Arizona Cancer Center

UAZ10-16-01 Phase II Study of Metformin in a Pre-prostatectomy Prostate Cancer Cohort

II Arizona Cancer Center

UCI09-13-01 A Phase IIa Trial of Metformin for Colorectal Cancer Risk Reduction among Patients with a History of Colorectal Adenomas and Elevated Body Mass Index

II University of California Medical Center at Irvine

UWI09-14-01 Phase IIA, Randomized Placebo-Controlled Trial of Single High Dose Cholecalciferol and Daily Genistein (G-2535) Versus Placebo in Men with Early Stage Prostate Cancer Undergoing Prostatectomy

II University of Wisconsin Hospital & Clinics

UWI10-16-01R A Randomized, Double-blind, Phase 1 Dose-escalation Study of the Novel Retinoid 9cUAB30

I University of Wisconsin Hospital & Clinics

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List of Definitions and Acronyms

Auditor: An appropriately trained individual responsible for conducting on-site audit and data verification visits to clinical sites in order to confirm participant eligibility, data accuracy, and compliance with regulatory requirements.

Auditing and Data Verification: The processes used to verify the accuracy of reported clinical data, informed consent, participant eligibility and agent dispensing records against primary source documents; and to ensure investigator compliance with the protocol, Good Clinical Practice Guidelines, and all applicable policies, procedures and regulatory requirements including FDA regulations.

Capability Maturity Model Integration (CMMI): A process improvement approach that provides organizations with the essential elements of effective processes. It can be used to guide process improvement across a project, a division, or an entire organization.

http://cmmiinstitute.com/

Center for Biomedical Informatics and Information Technology (CBIIT): Principal activities of CBIIT include developing, coordinating, and deploying enterprise-wide biomedical-informatics and scientific-management information-technology (IT) systems, infrastructure, open-source applications, semantics, and data resources in support of the National Cancer Institute's research agenda.

Clinical Data Transfer (CDT) Website: A limited access website which serves as a resource for the Principal Investigators, Consortia Lead Site Coordinators, designated CLO staff, and selected DCP staff and contractors. The website houses materials specific to DCP Consortia clinical trials including SAS datasets, annotated CRFs, data management reports, policies and procedures as well as other resources for the Consortia staff.

Clinical Research Associate (CRA): An appropriately qualified individual, by training and experience, who is responsible for assuring that clinical trials are conducted according to appropriate procedures and all applicable government regulations. The CRA may be responsible for conducting on-site visits to clinical centers to verify participant eligibility, data accuracy, and compliance with regulatory requirements.

Common Data Elements (CDEs): Standardized terms (i.e., questions and values) used in collection and reporting of data for DCP clinical trials to ensure consistency and promote data sharing. Common Data Elements are accessed through the Cancer Data Standards Registry and Repository (caDSR) which is managed by CBIIT.

Consortia Clinical Data Transfer System (CCDS): A mechanism that serves to facilitate the transfer of data from the DCP Oracle Clinical Remote Data Capture (OC-RDC) database to DESK for use in reporting of participant–level data.

Consortia for Early Phase Prevention Trials: The Phase 0/I/II Cancer Prevention Clinical Trials Program through which the Division of Cancer Prevention conducts systematic early clinical development of promising preventive agents. The program was first funded in 2003 with a core of six major medical research centers, and was renewed in 2012 with five of these major medical research centers chosen to lead the studies.

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Consortia Lead Organization (CLO): An institution awarded a contract to conduct Phase 0/I/II cancer prevention clinical trials under DCP’s Early Phase Prevention Trials Program.

Contracting Officer (CO): An individual responsible for ensuring performance of all necessary actions for effective contracting, ensuring compliance with the terms of the contract, and safeguarding the interests of the United States in its contractual relationships. [Reference: FAR Subpart 1.6—Career Development, Contracting Authority, and Responsibilities; 1.602- 2 Responsibilities.]

Contracting Officer’s Representative (COR): An individual who is designated and authorized in writing by the contracting officer to perform specific technical or administrative functions on contracts or orders. [Reference: FAR Subpart 1.6—Career Development, Contracting Authority, and Responsibilities; 1.602-2 Responsibilities.]

DCP Collaboration Repository (DCPCR): An Oracle®-based application that provides a single common point of access for DCP and its contractors from which DCP enterprise information may be shared in a centralized secure and organized environment.

DCP Enterprise System Knowledgebase (DESK): The DCP central database is an Oracle® application managed by DCP that serves as the central database for management of administrative and selected participant level data for DCP sponsored clinical trials.

DCP HelpDesk: The phone and email support service provided to DCP lead organizations and their participating organizations that require assistance with information about activities related to DCP cancer prevention clinical trials.

Initiation Visit: A type of site visit conducted to verify that all regulatory, pharmacy and other requirements are in place before implementation of a DCP clinical trial.

Interim Visit: A type of audit visit scheduled in addition to the annual audit visit. Interim visits are scheduled at the request of the COR and/or DCP staff and may occur at either the Lead Organization or Participating Organization.

Lead Organization: The organization awarded a contract by DCP to conduct Phase 0-II cancer prevention clinical trials through the DCP Consortia or other clinical trials program.

Medical/Scientific Monitor: The Medical or Scientific Monitor provides specified regulatory, technical and scientific oversight for assigned protocols. In addition, the Medical Monitor provides oversight of serious adverse event (SAE) reporting and subject safety.

Minimum Data Set (MDS): A collection of specified administrative, participant demographic and adverse event data submitted monthly that serves as a primary source of clinical trials information for Consortia 2012 clinical trials.

Oracle® Clinical-Remote Data Capture (OC-RDC): An electronic data management system used for the centralized collection and management participant-level data for designated Consortia 2003 studies. It serves as the database of record for Consortia 2003 clinical trials.

Participating Organization (PO): Participating organizations are DCP-approved organizations that have an agreement with the lead organization to participate in DCP cancer prevention clinical trials. Lead organizations may have none, one or more than one participating organization.

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Scientific Misconduct: Fabrication (made up data or results, including the action of recording or reporting them), falsification (manipulating research materials, equipment, processes, or changing or omitting data or results such that the research is not accurately represented in the research record), plagiarism, or other deliberate practices that are taken to mislead the sponsor of the research. It does not include honest error or honest differences in interpretations or judgments of data. [Reference: Office of Research Integrity (ORI) Guidelines for Assessing Possible Research Misconduct in Clinical Research and Clinical Trials].

Standard Operating Procedures (SOP): Written guidelines that describe the CLO and PO roles and responsibilities in the oversight and management of DCP cancer prevention trials.

Task Order: The issuance of orders for the performance of tasks during the period of an Indefinite Delivery, Indefinite Quantity (IDIQ) contract (i.e., a contract for services that does not procure or specify a firm quantity of services other than a minimum or maximum quantity).

[Reference: Federal Acquisition Regulation (FAR) Subpart 16.5—Indefinite-Delivery Contracts;

16.501-1 Definitions]