TOOLS, PRODUCTS, AND RESOURCES

CTEP’s Online Resources for Investigators

http://ctep.cancer.gov/investigatorResources/default.htm

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

• Investigators’ Handbook:
  (http://ctep.cancer.gov/handbook/index.html)
  The handbook 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) v3.0 and v4.0:
  (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm)
  These are standards used to grade, assign attribution, and report adverse effects experienced by patients in clinical trials

• Adverse Event Expedited Reporting System (AdEERS):
  (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/adeers.htm)
  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:
  (https://cabig.nci.nih.gov/concepts/caDSR/)
  A repository of terms that are used when collecting patient information for clinical trials or cancer care. A web browser application provides access to view the CDE Dictionary, and other tools that are part of the Cancer Data Standards Repository (caDSR) are provided for configuring electronic submission of data.

• Clinical Data Update System (CDUS):
  (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/cdus.htm)
  The mechanism used when submitting specified data for CTEP-approved clinical trials

• Clinical Trials Monitoring Branch — Auditing Information System (CTMB-AIS):
  (http://ctep.cancer.gov/branches/ctmb/default.htm)
  A web-based information system that permits online submission of data collected during quality assurance audits of CTEP-sponsored cooperative group clinical trials