Data Management. Anne Tompkins. 1/18/2005. Acronyms. GCP: Good Clinical Practices CFR: Code of Federal Regulations ICH: International Conference on Harmonisation CRF: Case Report Form FDA: Food and Drug Administration IRB: Institutional Review Board IND: Investigational New Drug
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In the source documents
1. It is the data that document the trial
2. Study was carried out according to protocol
- Diary/pill count
Patient’s Medical Record
Clean data in a form you can analyze!
Fast is fine, but accuracy is everything.
Everyone else must show us the data!
Good Clinical Practices in FDA-regulated clinical trials:
Code of Federal Regulations: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
Comparison of FDA and HHS Human Subject Protections: http://www.fda.gov/oc/gcp/comparison.html
Guidance for Industry. E6 Good Clinical Practice: Consolidated Guidance:
Office for Human Research Protections:
Cancer Therapy Evaluation home Page: