NCI National Clinical Trials Network (NCTN) Program Guidelines
NCI National Clinical Trials Network (NCTN) Program Guidelines NCI National Clinical Trials Network (NCTN) Program Guidelines
PART 4: Appendices Section V – Important Definitions, Abbreviations, & NIH/NCI URLs C. Important Abbreviations Referenced in these Guidelines ABBREVIATION FULL TERM AD Associate Director, CTEP, DCTD AdEERS Adverse Event Expedited Reporting System ARA Awaiting Receipt of Application BIQSFP Biomarker, Imaging, and Quality of Life Studies Funding Program BRB Biometric Research Branch (in DCTD) CBO Common Budget Outline CCCT Coordinating Center for Clinical Trials (in NCI OD) CCOP Community Clinical Oncology Program (in DCP) CDE Common Data Elements CDP Cancer Diagnosis Program (in DCTD) CDUS Clinical Data Update System CFR Code of Federal Regulations CIB Clinical Investigations Branch (in CTEP) CIP Cancer Imaging Program (in DCTD) CIRB Central Institutional Review Board at NCI CRA Clinical Research Associate CRADA Cooperative Research and Development Agreement CSA Clinical Supply Agreement CSR Center for Scientific Research (at NIH) CTA Clinical Trial Agreement CTAC Clinical Trials and Translational Research Advisory Committee CTCAE Common Toxicity Criteria for Adverse Events CTEP Cancer Therapy Evaluation Program (in DCTD) Page 220 of 241
PART 4: Appendices Section V – Important Definitions, Abbreviations, & NIH/NCI URLs CTMB Clinical Trials Monitoring Branch (in CTEP) CTSU Cancer Trials Support Unit CTRP Clinical Trials Reporting Program CTWG Clinical Trials Working Group CTROC Clinical and Translational Research Operations Committee DAR Drug Accountability Record DCP Division of Cancer Prevention DCTD Division of Cancer Treatment and Diagnosis DEA Division of Extramural Activities DHHS Department of Health and Human Services DMC Data Monitoring Committee (also known as Data and Safety Monitoring Board) DRB Diagnostics Evaluation Branch (in CDP) DSMB Data and Safety Monitoring Board (also known as Data Monitoring Committee) FDA Food and Drug Administration FWA Federalwide Assurance (for OHRP) GCP Good Clinical Practice HIPAA Health Insurance Portability and Accountability Act IDB Investigational Drug Branch (in CTEP) IND Investigational New Drug Application IRB Institutional Review Board LOI Letter of Intent NCAB National Cancer Advisory Board NCI National Cancer Institute NCI SSC NCI Scientific Steering Committees NIH National Institutes of Health NCTN National Clinical Trials Network Page 221 of 241
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PART 4: Appendices Section V – Important Definitions, Abbreviations, & NIH/<strong>NCI</strong> URLs<br />
CTMB <strong>Clinical</strong> <strong>Trials</strong> Monitoring Branch (in CTEP)<br />
CTSU Cancer <strong>Trials</strong> Support Unit<br />
CTRP <strong>Clinical</strong> <strong>Trials</strong> Reporting <strong>Program</strong><br />
CTWG <strong>Clinical</strong> <strong>Trials</strong> Working Group<br />
CTROC <strong>Clinical</strong> and Translational Research Operations Committee<br />
DAR Drug Accountability Record<br />
DCP Division of Cancer Prevention<br />
DCTD Division of Cancer Treatment and Diagnosis<br />
DEA Division of Extramural Activities<br />
DHHS Department of Health and Human Services<br />
DMC Data Monitoring Committee (also known as Data and Safety Monitoring Board)<br />
DRB Diagnostics Evaluation Branch (in CDP)<br />
DSMB Data and Safety Monitoring Board (also known as Data Monitoring Committee)<br />
FDA Food and Drug Administration<br />
FWA Federalwide Assurance (for OHRP)<br />
GCP Good <strong>Clinical</strong> Practice<br />
HIPAA Health Insurance Portability and Accountability Act<br />
IDB Investigational Drug Branch (in CTEP)<br />
IND Investigational New Drug Application<br />
IRB Institutional Review Board<br />
LOI Letter of Intent<br />
NCAB <strong>National</strong> Cancer Advisory Board<br />
<strong>NCI</strong> <strong>National</strong> Cancer Institute<br />
<strong>NCI</strong> SSC <strong>NCI</strong> Scientific Steering Committees<br />
NIH <strong>National</strong> Institutes of Health<br />
<strong>NCTN</strong> <strong>National</strong> <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong><br />
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