ACRP-CP LATEST TEST GUIDE & ACRP-CP LATEST STUDY MATERIALS

ACRP-CP Latest Test Guide & ACRP-CP Latest Study Materials

ACRP-CP Latest Test Guide & ACRP-CP Latest Study Materials

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ACRP Certified Professional Exam Sample Questions (Q49-Q54):

NEW QUESTION # 49
Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

  • A. PI
  • B. Sponsor
  • C. Applicable regulatory authorities
  • D. Applicable site SOPs

Answer: C

Explanation:
The confidentiality and privacy rules protecting human subjects in clinical research are established by applicable regulatory authorities, such as the FDA or EMA, and must be followed by all research sites. These regulations ensure that participants' personal data are handled securely and ethically.
GCP guidelines mandate compliance with local, national, and international regulations regarding data confidentiality and privacy.
"Confidentiality and privacy protections are determined by applicable regulatory authorities and must be adhered to by all study sites." Objectives:
* Protect participant privacy.
* Ensure compliance with data protection regulations.


NEW QUESTION # 50
Who ensures information regarding payments to subjects is documented in a written consent form?

  • A. IRB/IEC
  • B. PI
  • C. Sponsor
  • D. Coordinator

Answer: A

Explanation:
The IRB/IEC is responsible for reviewing and approving the consent form, which must include any information about payments to participants. This ensures transparency and ethical compliance regarding compensation.
The answer is verified according to GCP guidelines, which mandate IRB/IEC review of consentforms, including payment details.
"IRB/IEC must ensure that the informed consent process is thorough and includes disclosure of any compensation or payment to participants." Objectives:
* Guaranteeing informed consent quality
* Ensuring transparency about participant payments


NEW QUESTION # 51
A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

  • A. Notify the sponsor.
  • B. Notify the subject.
  • C. Notify the regulatory authority.
  • D. Withdraw the subject.

Answer: A

Explanation:
When a protocol deviation is identified, especially one involving inclusion criteria, the sponsor must be notified immediately. The sponsor will assess the deviation and determine whether the subject can continue in the study. Early notification ensures appropriate action and compliance with protocol and regulatory guidelines.
This answer aligns with GCP principles that mandate sponsor notification in case of protocol deviations, especially when they may impact participant safety or data integrity.
"Any deviation from the protocol that affects subject eligibility must be reported to the sponsor immediately for evaluation and guidance." Objectives:
* Maintain adherence to protocol inclusion criteria.
* Report deviations promptly for safety assessment.


NEW QUESTION # 52
A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the
1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP. What is the participant's overall compliance?

  • A. 71%
  • B. 80%
  • C. 66%
  • D. 77%

Answer: D

Explanation:
Step 1:Calculate the total number of tablets dispensed:
* Month 1: 35 tablets
* Month 2: 35 tablets
* Total: 70 tablets
Step 2:Calculate the number of tablets returned:
* Month 1: 10 tablets
* Month 2: 12 tablets
* Total: 22 tablets
Step 3:Calculate the number of tablets taken:
* 70 - 22 = 48 tablets
Step 4:Calculate compliance:
* Compliance = (Tablets Taken / Total Tablets) × 100
* Compliance = (48 / 62) × 100 # 77%
GCP guidelines require accurate calculation of compliance based on returned IP counts, ensuring proper dose administration monitoring.
"Compliance rates are calculated by comparing the number of tablets taken to the total number of tablets dispensed, considering the returned count." Objectives:
* Monitor compliance with IP administration.
* Ensure accurate calculation of adherence rates.


NEW QUESTION # 53
A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?

  • A. 5 participants
  • B. 6 participants
  • C. 3 participants
  • D. 4 participants

Answer: C

Explanation:
Since the protocol specifies that participants withdrawn due to an Adverse Event (AE) should not bereplaced, only the participants withdrawn for noncompliance (3 in total) should be replaced. The participant who withdrew consent due to severe nausea (an AE) and the one who discontinued IP due to hospitalization should not be replaced.
GCP guidelines specify that replacement of subjects should follow the protocol criteria, particularly when AEs are involved.
"Participants withdrawn due to AEs should not be replaced if the protocol stipulates this condition, while noncompliant participants may be replaced." Objectives:
* Follow protocol guidelines for participant replacement.
* Ensure compliance with study criteria.


NEW QUESTION # 54
......

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