Data Reporting and Monitoring
Toxicity Criteria:
- Common Toxicity Criteria (CTC)
- CTC v2.0
- CTCAE v3.0
RECIST (Response Evaluation Criteria In Solid Tumors):
- RECIST FAQs and Article
- NIH-2819: Tumor Measurement/RECIST Criteria
- CTEP RECIST document
- WHO VS RECIST document
Regulatory:
- Food and Drug Administration (FDA)
- Good Clinical Practice in FDA-Regulated Clinical Trials
- Center for Biologics Evaluation and Research (CBER), FDA
- Center for Drug Evaluation and Research (CDER), FDA
- FDA MedWatch
- Office of Regulatory Affairs, FDA
- International Conference on Harmonization (ICH)
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