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Erstellt von Tim Bielecki
vor mehr als 5 Jahre
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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)