NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers
conducted under Network Group or company INDs or IDEs with appropriate monitoring per
the Network Group data and safety monitoring plan or Data and Safety Monitoring Board
(Data Monitoring Committee) policy for randomized phase 2 trials.
� Agents from NCI/DCTD Collaborators: All NCTN studies using NCI/DCTD-sponsored
investigational agents or agents supplied by CTEP, CIP, or other DCTD programs under
Collaborative Agreements (such as Cooperative Research and Development Agreements
[CRADAs], Clinical Trial Agreements [CTAs], and Clinical Supply Agreements [CSAs]) must be
conducted in accordance with the terms of the NCI/CTEP Intellectual Property Option to
Collaborators, found on the CTEP website at:
http://ctep.cancer.gov/industryCollaborations2/intellectual_property.htm, and the NCI
Standard Protocol Language for CRADAs and CTAs. When new avenues of cancer therapy
involving any investigational agents are pursued, the clinical information obtained in the
study should be acceptable to the FDA and other health authorities for inclusion in a
possible licensing application. When NCI/DCTD and the Network Group contract with the
same company (or companies) for support for the same trial (i.e., trials conducted under a
NCI/DCTD Collaborative Agreement, the Group contracts may require review by the
appropriate DCTD program at the discretion of NCI (see Part 4 – Appendices - Section I.F. in
these Guidelines).
� NCTN Required Tools and Services: Network Groups are required to use standard NCTN
tools and services for all NCTN trials including, but not limited to: (a) the Common Data
Management System for study design/build and data collection with case report reports
(CRFs) designed by the SDMC that are compliant with the NCTN Program approved sections
of the data dictionary for common data elements in the NCI Cancer Data Standards Registry
and Repository (caDSR) (see https://cabig.nci.nih.gov/community/concepts/caDSR/); (b)
NCTN information system for tracking biospecimen collection from NCTN trials (in
development); (c) NCTN Oncology Patient Enrollment Network (OPEN) and Regulatory
Support Services (RSS) via the Cancer Trials Support Unit (CTSU) for central registration and
randomization of patients onto NCTN trials; (d) the NCI Common Terminology Criteria for
Adverse Events (CTCAE); (e) the Comprehensive Adverse Event and Potential Risks (CAEPR)
for agents, if available; (f) the NCTN specification for appropriate designation of per case
management funding for trials prior to study activation; and (g) review of all pediatric phase
2 and phase 3 trials and all adult phase 3 trials and selected phase 2 trials by the appropriate
NCI Central Institutional Review Boards.
� Adverse Event Reporting and Patient Safety: The Network Group Operations Center must
establish a system for assuring expedited reporting of all serious adverse events to ensure
potential patient safety issues can be identified and addressed quickly. Adverse events
should be reported using the Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
or most recent version, which is NCI and DCTD’s standard language for reporting adverse
events in oncology clinical trials.
� For agents under DCTD-sponsored INDs, this involves reporting to the appropriate DCTD
program via the Adverse Event Expedited Reporting System (AdEERS), or its successor
application, according to the guidelines specified in each protocol. Network Groups must
also use AdEERS, or its successor application, for expedited reporting of serious adverse
events for all NCTN trials (even those not under a DCTD IND or not under any IND/IDE) since
AdEERS provides reporting pathways for studies that do not include DCTD IND agents, as
well as pathways for studies that do not include any agents (e.g. surgical only study,
radiation only study). Serious adverse event reporting for all NCTN trials should follow the
“NCI Guidelines for Investigators: Adverse Event Reporting Requirements for DCTD (CTEP
and CIP) and DCP INDs and IDEs” available at:
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/aeguidelines.pdf
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