This is a glossary of terms related to the RIAT initiative, including a taxonomy for regulatory documents. It was developed, in part, with support from funds provided by the Cochrane Methods Innovation Fund.
- Access to Information Act
- Advisory Committee documents
- Aggregate data
- Amendments
- Annotated Case Report Form
- Appendices
- AusPAR
- Australian Public Assessment Report
- Biologic License Application
- Blank Case Report Form
- Case Report Form
- Centralised procedure
- Certificate of analysis
- Clinical Overview
- Clinical Study Report Appendices
- Clinical Study Report
- Clinical Summary
- Clinical trial registry
- Common Technical Document
- CONSORT
- CRF
- CSR
- CTD
- Drug Approval Package
- Drug label
- Drugs@FDA
- EMA
- EMA Policy 0043
- EMA Policy 0070
- EMA Policy on Publication of Clinical Data
- EPAR
- European Medicines Agency
- European Public Assessment Report
- FDA
- FDA Advisory Committee meeting materials
- FOI
- FOIA
- Food and Drug Administration
- Freedom of Information
- Freedom Of Information Act
- ICH E3 guideline
- ICSR
- IMRAD
- Individual listings
- Individual participant data
- Informed Consent Form
- Integrated Summary of Effectiveness and Integrated Summary of Safety
- Integrated Summary of Safety
- Introduction, Methods, Results, and Discussion
- Investigational Medicinal Product Dossier
- Investigator's Brochure
- IPD
- Licence/License
- Marketing Authorisation Holder
- Marketing Authorization Application
- Medical Officer Report
- Medical Officer Review
- Medical Review
- MedWatch
- Module 2.5 (Clinical Overview) & Module 2.7 (Clinical Summary)
- Module 5
- Narratives
- New Drug Application
- Patient Information Leaflet
- Periodic Safety Update Report
- Phamacovigilance
- Protocol
- Published trial
- Regulatory document
- Report and Analysis Plan
- Serious Adverse Event narratives
- Statistical Analysis Plan
- Statistical Officer Review
- Statistical Report
- Statistical Review
- Study ID
- Summary Basis of Approval
- Summary of Product Characteristics
- Trial Master File
- Trial Protocol
- Trial Registration
- Unpublished data