NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group
Statistics and Data Management Centers (SDMCs)
(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); and
(e) the Comprehensive Adverse Event and Potential Risks (CAEPR) for agents, if available.
During the approval process for study protocols and amendments, NCI/DCTD ensures that these
standard NCTN tools and services are used. In addition, Network Group trial protocols will be
periodically audited by NCI/DCTD to ensure that the tools related to common data elements in
compliance with the NCTN Program approved sections of the data dictionary for common data
elements in caDSR are used in the data collection instruments for the NCTN trials. If issues with
compliance are identified, the NCI/DCTD will work with the Network Group to develop a
corrective action plan.
2.2.2 Data Reporting Requirements
The SDMC must have policies and procedures in place to ensure that data reporting
requirements are fulfilled in a timely manner including the major data reporting requirements
outlined below.
Adverse Events: The SDMC should assist its associated Network Group Operations Center in
meeting its responsibility for adverse event reporting. This includes using the most recently
approved version of the Common Terminology Criteria for Adverse Events Version (CTCAE),
which is the NCI’s standard language for reporting adverse events in clinical trials, and is
provided on the NCI/DCTD/CTEP website at: http://ctep.cancer.gov/reporting/ctc.html.
Expedited reporting of all serious adverse events should be performed via CTEP’s Adverse Event
Expedited Reporting System or AdEERS (or its successor system), as described at
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/adeers.htm according to
the guidelines specified in each protocol.
Clinical Data Update System (CDUS/CDS): The SDMC, working with the associated Network
Group Operations Center, is responsible for coordinating the timely reporting of data from
Network Group clinical trials to CTEP using the Clinical Data Update System (CDUS) or its
successor application as described at
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/cdus.htm. For clinical
trials that do not use CTEP IND agents, reporting to CTEP will generally consist of CDUS
abbreviated procedures (primarily demographic data). For studies using CTEP IND agents, CDUS
complete reporting procedures may be required to capture demographic, adverse event
information (by course), and response data. CDUS complete reporting is required for phase 1
studies and phase 2 studies using CTEP IND agents, while abbreviated CDUS reporting is usually
used for phase 3 studies; however, complete reporting of CDUS data on adverse events may be
required for phase 3 trials by CTEP under certain circumstances.
Clinical Trials Reporting Program (CTRP) & Clinicaltrials.gov Reporting System: The SDMC,
working with the associated Network Group Operations Center, is responsible for coordinating
the registration of and reporting on Network Group studies to the NCI Clinical Trials Reporting
Program (CTRP) as described at: http://www.cancer.gov/clinicaltrials/conducting/ncictrp/main
as well as the U.S. National Library of Medicine clinical trials database (i.e., at
www.clinicaltrials.gov). Changes in the trial design and accrual as well as results reporting from
NCTN trials are also required to be reported in clinicaltrials.gov as required under the Food and
Drug Administration Amendments Act (FDAAA), Section 801.
Report of Studies: The SDMC, working with the Network Group Operations Center, is
responsible for providing a semi-annual Report of Studies on all Network Group trials. The
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