NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Lead Academic Sites
are submitted accurately and in a timely manner to the appropriate Network Group Statistics
and Data Management Centers.
4.1.6 Quality Assurance and Onsite Auditing
Responsibilities for quality assurance of the data (and biospecimens) submitted for NCTN trials
as well as auditing include, but are not limited to, the following:
� Pathology: Submission of appropriate materials to allow verification of pathologic
diagnosis, when relevant.
� Biospecimens (including integral assays, -omics, Pharmcokinetics, Pharmacodynamics):
Submission of appropriate biospecimens to allow for review/analysis of protocol-specified
tests and parameters.
� Radiation therapy: Submission of appropriate materials to allow review (either concurrent
or retrospective) of port films and compliance with protocol-specified radiation doses for
individual patients, when relevant.
� Chemotherapy & Other Systemic Therapies: Submission of appropriate data to allow
determination of protocol compliance with chemotherapy or other systemic therapy dose
administration and dosage modification.
� Surgery: Submission of appropriate information to allow review of protocol-specified
surgical procedures.
� Diagnostic Imaging: Submission of appropriate imaging data [images and associated metadata
(clinical or technical) as appropriate] to allow central review of staging, reported
responses, and adequacy of imaging when required by a particular protocol or for an audit.
� Onsite Auditing: Cooperation with Network Groups’ data monitoring and onsite auditing
programs with appropriate compliance with the onsite auditing program requirements. See
Quality Assurance in Part 1.IV.D.4 for information on the procedures that should be
followed in the event that any data irregularities are identified through the audit program or
other quality control procedures.
4.2 Site Accrual Program
Network Lead Academic Participating Sites are responsible for accrual to all trials conducted across the
NCTN from the main academic center and its essential components, and that of any affiliates included
in their award, and for achieving threshold accruals at the main academic center and its essential
components. Investigators at the Network Lead Academic Participating Sites should be involved in the
acquisition of protocol-specified tumor specimens and other biospecimens in addition to all relevant
protocol required clinical data. Network Lead Academic Participating Site investigators should ensure
that biospecimens and/or other data required for ancillary studies are submitted to the appropriate
laboratories/tumor banks and Network Group SDMCs.
Network Lead Academic Participating Sites are responsible for assuring that institutional investigators
enrolling patients on NCTN trials are NCI registered investigators (i.e., have Form FDA 1572 on file with
the NCI). Network Lead Academic Participating Sites also must ensure that the main institution, as well
as any affiliates, are in compliance with NCI/DCTD/CTEP requirements for storage and accounting for
investigational agents, including complying with NCI/DHHS Drug Accountability Records (DAR)
procedures as described in the DCTD Investigators' Handbook at:
http://ctep.cancer.gov/handbook/index.html and are in compliance with FDA requirements for
investigational agents.
4.3 Compliance with Federal Regulations for Clinical Research
Lead Academic Participating Sites awardee(s) should have policies and procedures for ensuring
compliance by the main academic center and its essential components (and any affiliates completely
managed by the main academic institution/site) with the policies and procedures for meeting federal
regulations for the protection of human subjects. These include the following:
� Assuring that all sites have current, approved Federalwide Assurances (FWAs) on file with OHRP;
Page 68 of 241