CTEP, NCI Guidelines: Adverse Event Reporting Requirements
Clinical Data Update System (CDUS)
Primary data reporting mechanism for all NCI-sponsored clinical trials.
CTCAE (formerly known as CTC) v2.0 and v3.0
Standard terminology used to name and to describe the severity (grade) of Adverse Events that occur in the treatment of cancer.
Adverse Event Expedited Reporting System (AdEERS)
System for all NCI collaborators providing electronic acquisition, exchange, submission, and analysis of Expedited Reports for serious and/or unexpected Adverse Events.
Gender and Minority Accrual Data
NIH Policy and Guidelines on the Inclusion of Women and Minorities Subjects in Clinical Research
NCI Secondary AML/MDS Form (PDF)
Form to be submitted to CTEP within 30 days of AML/MDS/ALL diagnosis following systemic anti-cancer therapy on NCI-sponsored trials.
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