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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Clinical Trial Operations | - Study start-up activities
|
| Topic 2: Professional Responsibilities | - Communication and collaboration
|
| Topic 3: Quality Management | - Risk management
|
| Topic 4: Ethical and Participant Safety Considerations | - Regulatory compliance
|
| Topic 5: Data Management and Documentation | - Clinical trial documentation
|
ACRP Certified Professional Sample Questions:
1. Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?
A) Report a protocol deviation to the IRB/IEC.
B) Notify the sponsor.
C) Notify the PI.
D) Call the participant to return for an unscheduled visit.
2. Who on the local site research study team is accountable for the unblinding documentation of IP?
A) CRC
B) Regulatory manager
C) PI
D) Pharmacist
3. The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?
A) Impact of an approved vaccine against the disease
B) Occurrence of known side effects of the IP
C) Time to occurrence of symptoms of the disease
D) Use of concomitant medications to treat the symptoms
4. The inclusion and exclusion criteria are in place so all subjects are:
A) Healthy and willing to complete the clinical trial.
B) Medically appropriate and protected from ethical vulnerability.
C) Patients with the disease under study and will not have any adverse events.
D) Ethically vulnerable and patients with the disease under study.
5. After the site qualification visit report has been finalized, it must be:
A) Included in the PI's regulatory file.
B) Kept in the CRO/sponsor's trial master file.
C) Sent to the IRB/IEC for review and approval.
D) Stored in the sponsor's budgets and contracts file.
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: C | Question # 3 Answer: C | Question # 4 Answer: B | Question # 5 Answer: B |
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