NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 2: Submission of New/Competing Application Section III.B.2.2 – Review Criteria Network Group SDMC Data Management Program: Does the applicant describe well defined policies and procedures for data management of NCTN trials led by the applicant's associated Network Group Operations Center (including approved, multi-center phase 2 and phase 3 trials that originated from investigators outside the Network Group Operations Center)? How appropriate and robust are the data management and study monitoring practices of the proposed SDMC, including the flow and review of data following submission from individual institutions/sites and investigators? How appropriate is SDMC training for investigators, Clinical Research Associates, and study chairs related to data management and study monitoring for clinical trials? How well do the data management systems employed by the proposed SDMC use standard NCTN tools including the NCTN Common Data Management System (CDMS) and use of NCTNapproved Common Data Element (CDEs) from the ca-DSR, the NCTN Regulatory Support System (RSS), the NCTN Oncology Patient Enrollment Network (OPEN), the NCI/DCTD Clinical Data Update Systems (CDUS/CDS), the NCI Expedited Adverse Event Reporting System (AdEERs), the NCI Common Terminology Criteria for Adverse Events (CTCAE) for data management for NCTN trials, and trial registration in the NCI Clinical Trials Reporting Program (CTRP) and in the U.S. National Library of Medicine (NLM) (www.clinicaltrials.gov) along with results reporting, as applicable? How able is the applicant to coordinate with the associated Network Group Operations Center to ensure that data and biospecimens can be made available to the public for future research? How robust are the applicant's policies and procedures for study monitoring as well as for data quality control and accuracy verification, including how the proposed SDMC would work with its associated Network Group Operations Center on auditing activities as well as other quality assurance programs? How comprehensive and appropriate are the applicant's methods for active trial monitoring, including procedures for accrual and biospecimen collection tracking, assessing case, eligibility and evaluability, ensuring timely medical review and assessment of patient data, monitoring of data timeliness, and facilitating SDMC staff interactions with study chairs? Does the proposed SDMC have appropriate procedures in place to ensure compliance with federal/DHHS/NIH/NCI regulations for clinical research involving human subjects as well as with NCI/NIH administrative requirements for conduct of clinical trials with respect to NCI/DCTD's IP Option and NCI/DCTD's collaborative binding agreements for NCI/DCTD IND studies? Does the SMDC have clear guidelines for institutions/sites related to data timeliness and metrics for data quality for the clinical trial data and timely reporting to the institutions/sites of this information that indicate its potential to operative efficiently within the NCTN Program? Do the facilities and equipment (including computer hardware and software) available as well as the information technology (IT) support for central storage, security, analysis and retrieval of clinical data for the proposed SDMC appear adequate for clinical trial research? Does the proposed SDMC have policies and procedures in place that are in compliance with federal regulations related to confidentiality of patient data, including the Health Insurance Portability and Accountability Act (HIPAA) regulations? Page 164 of 241
PART 2: Submission of New/Competing Application Section III.B.2.3 – Review Criteria Integrated Translational Science Center 2.3 Network Group Integrated Translational Science Support Center Review Criteria Only the review criteria described below (and the Additional Review Criteria – Overall listed in Part 2 – Section III.B.3.) will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 2.3.1 Overall Impact - Overall Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the proposed Network Group Integrated Translational Science Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the proposed Network Group Integrated Translational Science Center). 2.3.2 Scored Review Criteria – Overall Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a proposed Network Group Integrated Translational Science Center that by its nature is not innovative may be essential to advance a field. Significance Does the proposed Network Group Integrated Translational Science Center help address an important problem or a critical barrier to progress in the field? If the aims of the proposed Network Group Integrated Translational Science Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Investigator(s) Are the PD(s)/PI(s), collaborators, and other researchers well suited to the proposed Network Group Integrated Translational Science research plans as well as its plans for collaborations? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Since NCTN Program research projects/trials are collaborative, and regardless of whether the applicants choose to use the multi-PD/PI option, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the translational science research studies and pilot studies that the proposed Network Group Integrated Translational Science Center plans to perform? Innovation Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Page 165 of 241
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NCI National Clinical Trials Network (NCTN) Program Guidelines

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