An amendment sent to CTEP detailing any protocol change that occurs after CTEP approval and prior to local activation. Examples: The study is approved by CTEP with recommendations, which are incorporated prior to activation; these changes must be listed and submitted to CTEP as an activation amendment.
Adverse Event Expedited Reporting System. NCI’s online Serious Adverse Events reporting mechanism.
Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medical treatment or procedure regardless of whether it is considered related to the medical treatment or procedure. For NCI-sponsored trials, adverse events are defined in the Common Terminology Criteria for Adverse Events (CTCAE)
Membership program for small physician consortiums or individual MDs requiring affiliation with full member institutions
The Alliance for Clinical Trials in Oncology. An adult clinical trial group sponsored by the NCI, supporting research as one of the five members of the NCI’s National Clinical Trials Network (NCTN)
Changes to the protocol which directly affect patient care or treatment and may substantively increase the patient’s risk/benefit ratio. Examples: Additional/increased risk factors for patients, change in treatment regimen, or change in study parameters. Justification for the amendment is required, and must be approved by the NCI. The amendment date appears in the upper right hand corner of amended protocol pages. Amendments almost always require full board IRB review. (Compare to REVISION below.)