clinical trial
- Guideline or reference source
- ECA GAMP5 Approach and Risk Management
- ISO11615 IDMP Data elements and structures for the unique identification and exchange of regulated medicinal product information
- ISO11616 IDMP Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
- Definition
- any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational medicinal product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational medicinal product(s) with the object of ascertaining its safety and/or efficacy
- Abbreviation for
- CT
- Used For
- clinical investigation
- clinical study
- Broader Term
- pharmaceutical research
- Narrower Term
- pharmacodynamic study
- pharmacokinetic study
- Related Term
- case report form
- clinical development programme
- clinical study report
- clinical trial authorization
- clinical trial design
- nonclinical study
- post-authorisation safety study
- protocol
- trial site
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