U.S. National Institutes of Health

CTEP Online Resources for Investigators

http://ctep.cancer.gov/resources/index.html

CTEP offers investigators online resources for submitting data and reports, conducting research, and accessing reference materials:

  • Investigators’ Handbook ( http://ctep. cancer.gov/handbook/index.html):
    Offers practical information for oncologists, nurses, pharmacists, research administrators, and data managers about policies and procedures of DCTD with respect to the clinical use of its investigational agents, as well as guidance on protocol writing and submissions, reporting requirements, and agent accountability
  • Common Terminology Criteria for Adverse Events (CTCAE) v2.0 and v3.0: Standards used to grade, assign attribution, and report adverse effects experienced by patients in clinical trials
  • Adverse Event Expedited Reporting System (AdEERS): NCI’s Web-based system for submitting expedited reports for serious or unexpected events that occur during a clinical trial
  • Common Data Elements (CDE) Dictionary: A dictionary of terms that are used when collecting patient information for clinical trials or cancer care
  • Clinical Data Update System (CDUS): The mechanism used when submitting specified data for CTEP-approved clinical trials
  • Clinical Trials Monitoring Branch— Auditing Information System (CTMB-AIS): A Web-based information system that permits online submission of data collected during quality assurance audits of CTEP-sponsored cooperative group clinical trials