Application Information Archive

This webpage contains information from the last rounds of applications in support of CP-CTNet. It will be updated when the program renews.

On this page:

Notice of Funding Opportunity- active 6/28/19-8/30/19

Number: RFA-CA-19-031

Funding Opportunity Title: Cancer Prevention Clinical Trials Network (CP-CTNet): CP-CTNet Sites (UG1 Clinical Trial Required)

Announcement Type: Reissue of RFA-CA-18-029 (see pre-application webinar information for RFA-CA-029, no longer active, below)

Companion Funding Opportunity: None

Frequently Asked Questions

  1. (Received 7/1/19) (For those applicants who submitted to CP-CTNet previously) Should we submit as amended application (i.e. introduction + showing changes in the application document)? Or as a new application and address the critiques in the body of the application?

    Answer: This will be considered a resubmission, so you should address the prior critique in the "Introduction to the Application" and make changes as applicable. In the section about Additional Review Criteria (section V.1), Resubmissions, the standard verbiage says “For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

  2. (Received 7/1/19) Do we need to fill out the Human Subject Protection section since the proposed trials are samples for information only?

    Answer: The Human Subject Protection Section should be filled out since CP-CTNet is a clinical program that will eventually fund multiple clinical trials.

  3. (Received 8/15/19) Since we are required to complete the human subjects section for this grant, is it supposed to be general to incorporate all possible studies or is it to be specific to the sample concepts?

    Answer: The Human Subject section should be general for the range of studies that you expect to perform. This means that it should cover the sample concepts as well. However, if there is something specific to the sample concepts that deserves mention, you may want to directly address it in the Human Subjects section as well.

Pre-Application Webinar Information

Slides and Recordings and FAQs

Slide Presentation: Potential Applicant Webinar: Cancer Prevention Clinical Trials Network (CP-CTNet): CP-CTNet Site (UG1)

Slide Presentation: Potential Applicant Webinar: Cancer Prevention Clinical Trials Network (CP-CTNet): Data Management, Auditing, and Coordinating Center (DMACC)

Information and Resources for Centralized Data Management and Reporting

Medidata Rave® Data Capture & Management

NCI has designated Medidata Rave® as its recommended electronic data collection system for CP-CTNet to improve the consistency of data collection across a large number of institutions and trials. Medidata Rave is an electronic data capture (EDC) and clinical data management (CDM) platform for capturing, managing and reporting of clinical, operational and safety data within a single system. Rave enables users to efficiently and effectively map study-related processes and user responsibilities for recording patient information (i.e., visit, lab, and adverse event data) using common data elements (CDEs) forms that are customized for each study.

Data Integration Program

The Data Integration Program maintains a system for collecting and reporting a subset of clinical trial data to NCI and DCP via the monthly Minimum Data Set ( MDS) report. The MDS is a data reporting mechanism which allows submitters to report a defined subset of study data to NCI DCP. This subset of data is obtained from the study’s database of record and reported to NCI DCP monthly for NCI/DCP reporting requirements. The MDS report includes administrative, participant demographic, and adverse event data.

Accrual Quality Improvement and Tracking Program (AQuIP)

AQuIP is a dynamic clinical trial accrual improvement program based upon documented sponsor, study staff, and participant input. AQuIP data collection includes the strategies used to identify each potential participant as well as the reasons for individual screen failures or not enrolling into a trial. AQuIP consists of systematic planning, ongoing evaluation and responsive real-time actions that lead to measurable improvement in the accrual process.

Cancer Data Standards Repository (caDSR)

The caDSR and its associated applications provide centralized documentation to support the data management activities in the research community. It also provides access to common data elements (CDEs) to use when designing systems to capture, report, discover, and use data. The use of CDEs or common information building blocks addresses a biomedical data-management problem: namely, the varied ways in which similar or identical data can be collected and stored in databases. Inconsistency in data representation makes it difficult to aggregate and manage even modest-sized data sets in order to ask basic questions and obtain meaningful answers. The reuse of CDEs facilitates understanding, interpretation, and sharing of cancer research information, development of interoperable systems, and the collection of data generated by disparate experimental platforms. DCP has been using CDEs for approximately 15 years for their studies and has a total of 4,860 CDEs in their context. Each study is broken down into a classification scheme to inform users what CDE is being used for every question on a form or questionnaire.

DCP Contract Resources Supporting CP-CTNet

NCI Central Institutional Review Board (CIRB)

The NCI CIRB is dedicated to protecting the rights and welfare of participants in DCP cancer prevention trials. The CIRB membership satisfies the requirements of 45 CFR 46 and 21 CFR 56, and provides special expertise as needed to adequately assess human subjects protection concerns for each study that it reviews. The CIRB is responsible for conducting initial, amendment, and continuing reviews of studies, as well as the review of other study-specific documents (e.g., participant accrual materials) submitted by the Study Chair.

Regulatory Support Program

The Regulatory Support Program receives, reviews, and compiles scientific, safety, and clinical data for inclusion in Investigational New Drug Applications (INDs) and other regulatory submissions. In addition, the program provides adverse event data for the development of the Investigator's Brochures, and for safety data submissions to regulatory agencies and investigators. For multinational research efforts, DCP may direct the program to prepare submissions to international regulatory bodies. The program also maintains files of agreement documents and other documents from pharmaceutical companies including the use of agreements such as CRADAs (Cooperative Research and Development Agreement), Clinical Trial Agreements (CTAs), Confidential Disclosure Agreements (CDAs), and Material Transfer Agreements ( MTAs). The Regulatory Support Program works with physician investigators, non-physician investigators, and Associate Plus staff to register annually via the NCI Registration and Credential Repository (RCR) system.

Drug Repository Program

The Drug Repository Program serves as the centralized source of investigational agents and provides development services necessary to support early phase cancer prevention studies. The repository provides logistic organization for the procurement, tracking, labeling, storage, shipping, maintenance, testing, quality control, and distribution of investigational agents.

Biorepository Program

NCI anticipates a long-term solution for storing and sharing of biospecimens collected within CP-CTNet clinical trials.

Protocol Information Office (PIO) Support Program

The PIO support program oversees the process for receipt of concepts and protocols and for the review, documentation, and notification of concept/protocol review results. The program is responsible for electronic maintenance, tracking, and storage of all cancer prevention study files (e.g., documents, correspondence, reports, and other study-related information) from the concept stage all the way through implementation and completion of studies, including serving as the programmatic conduit to the CIRB for study protocol and patient-facing materials submissions.