Glossary

• Adverse events and adverse reaction-related definitions:
• Adverse drug reaction (ADR):
• Serious adverse event (SAE):
• Suspected unexpected serious adverse reaction (SUSAR):
• Agreement
• Assent
• Audit
• Audit certificate
• Audit report
• Audit trail
• Blinding/masking
• Case report form (CRF)
• Certified copy
• Clinical Trial
• Clinical trial/study report (CSR)
• Comparator
• Compliance (in relation to trials)
• Confidentiality
• Coordinating investigator
• Computerised systems validation
• Contract research organisation (CRO)
• Data acquisition tool (DAT)
• Data integrity
• Direct access
• Essential records
• Good Clinical Practice (GCP)
• Impartial witness
• Independent Data Monitoring Committee (IDMC)
• Informed consent
• Inspection
• Institution
• Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
• Interim clinical trial/study report
• Investigational product
• Investigator
• Investigator’s Brochure (IB)
• Investigator Site
• Legally acceptable representative
• Metadata
• Monitoring
• Monitoring Plan
• Monitoring report
• Multicentre trial
• Nonclinical study
• Protocol
• Protocol amendment
• Quality assurance (QA)
• Quality control (QC)
• Randomisation
• Reference safety information (RSI)
• Regulatory authorities
• Service provider
• Signature
• Source records
• Sponsor
• Sponsor-investigator
• Standard operating procedures (SOPs)
• Sub-investigator
• Trial participant
• Trial participant identification code
• Vulnerable participants