Serious Adverse Events
Timely reporting of adverse events and adverse drug reactions in clinical trials is required by Food and Drug Administration regulations and policies of the National Cancer Institute and SWOG Cancer Research Network. Such reporting improves both patient care and scientific communication by allowing rapid dissemination of new findings to other investigators studying the drug. Below are links to rules and tools to assist in this important process.
Serious Adverse Event - Expedited Reporting
- Cancer Therapy Evaluation Program Adverse Event Reporting System (CTEP-AERS)
- CTEP-AERS On-line Application
- CTEP-AERS Home Page. This page includes an information guide, training presentations, link to computer-based training.
- NCI Guidelines - Adverse Event Reporting
If you have questions regarding Serious Adverse Events, Serious Adverse Event Reporting or the CTEP-AERS reporting system, contact the SWOG SAE Coordinator (210-614-8808) or adr@swog.org.
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CTCAE 4.0 |
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National Cancer Institute / Cancer Therapy Evaluation Program |
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Food and Drug Administration |