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XyZ_Res
> 1572 Form > Flashcards
1572 Form Flashcards
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(48 decks)
E2: CLINICAL SAFETY DATA MANAGEMENT
E6: GUIDELINE FOR GOOD CLINICAL PRACTICE VOCABULARY
E6: 13 PRINCIPLES OF GCP
E6: IRB/IEC - Responsibilities
E6: IRB/IEC - Composition, Functions and Operations
E6: IRB/IEC - Procedures
E6: Investigator's Qualifications and Agreements
E6: Medical Care of Trial Subjects
E6: Communication with IRB/IEC
E6: Compliance with Protocol
E6: Investigational Products
E6: Informed Consent of Trial Subjects
E6: Records and Reports
E6: Safety Reporting
E6: Premature Termination or Suspension of a Trial
E6: Quality Management
E6: Quality Assurance and Quality Control
E6: Contract Research Organization (CRO)
E6: Trial Management, Data Handling, and Record Keeping
E6: Investigator Selection
E6: Notification/Submission to Regulatory Authority(ies)
E6: Confirmation of Review by IRB/IEC
E6: Information on Investigational Product(s)
E6: Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)
E6: Supplying and Handling Investigational Product(s)
E6: Safety Information
E6: Monitoring
E6: Monitoring Responsibilities
E6: Monitoring Report/Plan
E6: Audit
E6: Noncompliance/Premature Term or Suspension of Trial
E6: Multicentre Trials
E6: CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
E6: Investigation Brochure
E6: Essential Documents
1572 Form
Belmont Report
E8: GENERAL CONSIDERATIONS FOR CLINICAL STUDIES
E8: Phase I (Most typical kind of study: Human Pharmacology)
E 8: Phase II (Most typical kind of study: Therapeutic Exploratory)
E8: Phase III (Most typical kind of study: Therapeutic Confirmatory)
E8: Phase IV (Variety of Studies: - Therapeutic Use)
E8: General Consideration for Clinical Trials
E9: STATISTICAL PRINCIPLES FOR CLINICAL TRIALS
E11: Clinical Trials in Pediatric Population
Pill Calculation - Compliance
Nuremberg Code
Declaration of Helsenki
