GCP E6 Revision 3 AcademyGCP
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ICH GCP E6 (R3) Good Clinical Practice revision 3 Draft copy
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
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