Adverse Drug Reaction (ADR)

Adverse Event (AE)

Applicable Regulatory Requirement(s)

Approval (in relation to institutional review boards (IRBs))

Audit

Audit Certificate

Audit Report

Audit Trail

Blinding/Masking

Case Report Form (CRF)

Clinical Trial/Study

Clinical Trial/Study Report

Comparator (Product)

Compliance (in relation to trials)

Confidentiality

Contract

Coordinating Committee

Coordinating Investigator

Contract Research Organization (CRO)

Direct Access

Documentation

Essential Documents

Good Clinical Practice (GCP)

Independent Data Monitoring Committee (IDMC) (Data and Safety Monitoring
Board, Monitoring Committee, Data Monitoring Committee)

Impartial Witness

Independent Ethics Committee (IEC)

Informed Consent

Inspection

Institution (medical)

Institutional Review Board (IRB)

Interim Clinical Trial/Study Report

Investigational Product

Investigator

Investigator/Institution

Investigator’s Brochure

Legally Acceptable Representative

Monitoring

Monitoring Report

Multicenter Trial

Nonclinical Study

Opinion (in relation to Independent Ethics Committee)

Original Medical Record

Protocol

Protocol Amendment

Quality Assurance (QA)

Quality Control (QC)

Randomization

Regulatory Authorities

Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)

Source Data

Source Document

Sponsor

Sponsor-Investigator

Standard Operating Procedures (SOPs)

Subinvestigator

Subject/Trial Subject

Subject Identification Code

Trial Site

Unexpected Adverse Drug Reaction

Vulnerable Subjects

Well-being (of the trial subjects)

Certified Copy

Monitoring Plan

Validation of Computerized Systems

Good Clinical Practice (GCP)

This International Conference on Harmonization (ICH)