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| Pharmaceutical Clinical Trials
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Description:
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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- Adverse Events
- Code Breaking in Blinded Trials
- Definitions and Reporting Requirements
- Evaluation and Follow-up
- Contracts And Grants
- Budgets
- 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
- Confidentiality
- Data Safety Monitoring Committees
- Financial Risks to Subject
- Informed Consent and Protected Populations
- Liability (Investigator, Institution, Sponsor)
- Risks Versus Benefits
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- 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
- 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
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