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Pharmaceutical Clinical Trials


Our Pharmaceutical Clinical Trials (U.S) test measures your knowledge of the regulations and practices involved in conducting pharmaceutical trials in the United States. Designed for individuals with clinical trial experience, this test covers the following topics: Adverse Events, Contracts And Grants, Data Analysis, Data Collection, Drug Approval Process, Ethics/Protecting Human Subjects, Drug Supply Management, Study Design, Randomization and Blinding, and Informed Consent Process. This test will verify an individual's knowledge of the concepts and subjects tested. The results of this test do not imply that the individual possess the necessary skills to perform a specific procedure, nor treatment, nor is licensed, nor authorized, to practice any health care profession under any applicable laws.


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Test Outline

Adverse Events
Code Breaking in Blinded Trials
Definitions and Reporting Requirements
Evaluation and Follow-up
Contracts And Grants
Clinical Trials Agreements
Conflicts of Interest
Data Analysis
Basic Statistics Used in Analysis
Incomplete Data; Intent to Treat Analysis
Data Collection
Quality Assurance, Monitoring, Auditing
Source Documents
Types of Data
Drug Approval Process
Investigational New Drug Applications
Regulatory Agencies (FDA, DEA, etc)
Drug Supply Management
Drug Accountability
Drug Labeling
Lot/Batch Numbers, Expiration, Retesting
Storage and Security
Ethics / Protecting Human Subjects
Data Safety Monitoring Committees
Financial Risks to Subject
Informed Consent and Protected Populations
Liability (Investigator, Institution, Sponsor)
Risks Versus Benefits
General Study Conduct
Good Clinical Practices
Multisite Projects
Informed Consent Process
Alternatives and Withdrawal From Treatment
Elements of Consent Document
Subject Rights and Responsibilities
Institutional Review Boards
Committee Membership
Protocol Review Requirements
Randomization And Blinding
Randomization and Selection Bias
Site Records And Documents
Record Retention
Regulatory Documents
Study Design
Components of Study Protocol\Invest Broch
Sample Size and Comparitors
Study Objectives
Study Types and Phases