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It is a universally accepted fact that the ACRP-CP exam is a tough nut to crack for the majority of candidates, but there are still a lot of people in this field who long to gain the related certification so that a lot of people want to try their best to meet the challenge of the ACRP-CP exam. A growing number of people know that if they have the chance to pass the exam, they will change their present situation and get a more decent job in the near future. More and more people have realized that they need to try their best to prepare for the ACRP-CP exam.
1. Adverse event identification and classification
2. Safety information evaluation and communication
- Ethical principles
1. Clinical equipoise and therapeutic misconception
2. Human subject protections and privacy
- Clinical care and management of research participants
1. Informed consent development and review
2. Standard of care vs protocol requirements
3. Continuity of medical care
Regulatory and Compliance Requirements
17%
- ICH Guidelines
1. E6(R2)/E6(R3) Good Clinical Practice
2. E8 General Considerations for Clinical Trials
3. E2A Expedited Reporting
4. E11 Pediatric Trials
5. E9 Statistical Principles
- Compliance procedures
1. Regulatory submissions and approvals
2. Audits and inspections
- International standards
1. Declaration of Helsinki
Clinical Study Operations
15%
- Site management
1. Site personnel training and delegation
2. Study documentation and record keeping
- Project management
1. Vendor and stakeholder management
2. Timeline and budget management
Study Design and Conduct
17%
- Study implementation
1. Study monitoring and oversight
2. Investigational product management
3. Site selection and activation
- Study planning
1. Sample size and statistical considerations
2. Protocol development and amendments
3. Study population and eligibility criteria
ACRP Certified Professional Sample Questions:
The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?
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discussion
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