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ACRP Certified Professional Exam Sample Questions (Q50-Q55):

NEW QUESTION # 50
All site financial matters pertaining to a trial are listed in what document?

A. Informed consent form
B. Financial disclosure
C. Protocol
D. Signed contract

Answer: D

Explanation:
All financial agreements, including compensation, budgeting, and payment terms related to the conduct of a clinical trial, are documented in the signed contract between the sponsor and the site. This contract outlines the financial responsibilities and ensures transparency and compliance.
GCP guidelines stipulate that financial matters related to the conduct of a trial are to be formally documented in contractual agreements.
"The financial aspects of a clinical trial must be outlined in the signed agreement between the sponsor and the site, ensuring clear understanding of compensation and obligations." Objectives:
* Ensure financial transparency and accountability.
* Maintain compliance with contractual obligations.

NEW QUESTION # 51
Which of the following elements of the Informed Consent are NOT required?

A. Statement that study involves research
B. A description of potential benefits
C. Subject legal rights can be waived
D. A description of any reasonably foreseeable risks or discomforts

Answer: C

Explanation:
Informed consent must not include any language that implies a waiver of the participant's legal rights or releases the investigator, sponsor, or institution from liability for negligence. Such language violates ethical standards and the principles of voluntary participation.
According to GCP guidelines and ethical principles, the informed consent document must not include any clause that waives a participant's legal rights.
"An informed consent form must not include language that waives the participant's legal rights or releases the sponsor or investigator from liability." Objectives:
* Protect participant rights in clinical trials.
* Ensure that consent is given voluntarily and ethically.

NEW QUESTION # 52
Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?

A. CRA
B. CRO
C. Sponsor
D. Data Manager

Answer: C

Explanation:
The sponsor is responsible for establishing written procedures to ensure that all changes or corrections in Case Report Forms (CRFs) are properly documented and justified. These procedures must include who is authorized to make changes, how corrections are documented, and how they are endorsed by the investigator.
This practice ensures data accuracy and traceability.
GCP guidelines indicate that sponsors must establish and maintain procedures for data handling and documentation to ensure accuracy and reliability.
"The sponsor should develop written procedures to ensure that CRF changes are justified, documented, and endorsed by the investigator." Objectives:
* Maintain data accuracy and consistency.
* Ensure transparent documentation practices.

NEW QUESTION # 53
A study to determine the effective dose and regimen of a new IP for the treatment of hypothyroidism is considered to be:

A. Phase IV
B. Phase II
C. Phase I
D. Phase III

Answer: B

Explanation:
A Phase II clinical trial is typically conducted to evaluate the efficacy of a drug, determine the optimal dosing regimen, and further assess its safety profile. Since the objective is to establish the effective dose and regimen for hypothyroidism treatment, this clearly falls under Phase II.
GCP guidelines categorize Phase II trials as those aimed at determining efficacy and optimal dosing of investigational products.
"Phase II trials focus on determining the therapeutic efficacy, optimal dosage, and further evaluating the safety of the investigational product." Objectives:
* Identify effective dosing regimens.
* Evaluate therapeutic efficacy for targeted conditions.

NEW QUESTION # 54
Who is responsible for the ongoing safety evaluation of the IP?

A. Regulatory agency
B. Sponsor
C. IRB/IEC
D. PI

Answer: B

Explanation:
The sponsor is primarily responsible for the ongoing safety evaluation of the investigational product (IP) throughout the clinical trial. This responsibility includes monitoring adverse events, reporting serious adverse events (SAEs) to regulatory authorities, and updating the Investigator's Brochure (IB) with relevant safety data.
According to GCP guidelines, the sponsor must continuously evaluate safety data and report findings to regulatory bodies as necessary.
"The sponsor is responsible for the continuous safety monitoring of the investigational product and for ensuring that new safety information is communicated to investigators and regulators." Objectives:
* Ensure participant safety throughout the study.
* Maintain accurate and timely reporting of safety data.

NEW QUESTION # 55
......

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ACRP-CP Valid Test Pattern - Latest ACRP-CP Real Test

Latest ACRP-CP Real Test & Dump ACRP-CP Torrent

ACRP Certified Professional Exam Sample Questions (Q50-Q55):

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