The ADE pharmacovigiliance projects draws from publicly available standards and resources:
CTCAE (Common Terminology Criteria for Adverse Events) is NCI's standardized classification of adverse effects of drugs used in cancer therapy. The general guideline is:
- 1 - Mild
- 2 - Moderate
- 3 - Severe
- 4 - Life-threatening
- 5 - Death
MedDRA (Medical Dictionary for Regulatory Activities) is a medical terminology used by regulatory authorities and it is the adverse event classification dictionary endorsed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). We are using the current version (17) in the annotation tool. To access from:
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- Any browser (except the Annotation Server)
- The Annotation Server
Naranjo Scoring is used to for estimation of the probability that a drug caused an adverse clinical event.
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- Original Publication
- Usage for this project as outlined in the grant