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Topic 2: Ethical and Participant Safety Considerations
19%
- Safety monitoring and reporting
1. Adverse event identification and classification
2. Safety information evaluation and communication
- Clinical care and management of research participants
1. Standard of care vs protocol requirements
2. Informed consent development and review
3. Continuity of medical care
- Ethical principles
1. Human subject protections and privacy
2. Clinical equipoise and therapeutic misconception
Topic 3: Clinical Study Operations
15%
- Site management
1. Study documentation and record keeping
2. Site personnel training and delegation
- Project management
1. Timeline and budget management
2. Vendor and stakeholder management
Topic 4: Regulatory and Compliance Requirements
17%
- International standards
1. Declaration of Helsinki
- ICH Guidelines
1. E6(R2)/E6(R3) Good Clinical Practice
2. E2A Expedited Reporting
3. E11 Pediatric Trials
4. E9 Statistical Principles
5. E8 General Considerations for Clinical Trials
- Compliance procedures
1. Regulatory submissions and approvals
2. Audits and inspections
Topic 5: Study Design and Conduct
17%
- Study planning
1. Protocol development and amendments
2. Sample size and statistical considerations
3. Study population and eligibility criteria
- Study implementation
1. Study monitoring and oversight
2. Site selection and activation
3. Investigational product management
Topic 6: Professionalism and Ethical Practice
15%
- Professional standards
1. Confidentiality and conflict of interest
2. Role responsibilities and boundaries
- Continuous improvement
1. Quality assurance and process improvement
2. Professional development and education
ACRP Certified Professional Sample Questions:
While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?
A. Locate a translator and have them work with the person.
B. Have the Principal Investigator consent the person.
C. There are no circumstances under which this person can be enrolled.
D. Get an impartial witness involved in consenting this person.
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A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?
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What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?
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discussion
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