Across
- 1. GMP regulation applicable to computer system
- 8. Validation performed after a system has been in operation for some time using historical data
- 12. The document participants sign before joining a trial
- 13. 4 Step cycle for continuous improvement
- 14. Regulatory Body for Drug Safety in India
Down
- 2. Detailed document summarizing global safety data over a period
- 3. One of the 6'M's in the Fishbone Diagram
- 4. Reporting that is voluntary, where no active measures are taken to look for effects
- 5. Term for a drug that treats rare diseases
- 6. Trial phase focusing on safety and efficacy
- 7. Information suggesting a potential causal link between drug and AE that requires further investigation
- 9. document that summarizes scientific and administrative information to streamline the drug approval process
- 10. Committee that reviews ethical aspects of a trial
- 11. System used to collect trial data
- 15. Acronym for a serious, unexpected adverse reaction