GCP Related MCQs

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Questions and Answers

What is essential for the IRB/IEC when determining the composition of its members?

All members must come from the same institution.

Members must have a minimum of 10 years of experience.

At least one member should be independent of the institution/trial site. (correct)

The composition must consist entirely of scientific members.

Which responsibility does the IRB/IEC have regarding trial subjects and payments?

To evaluate if the payment amounts could lead to undue influence. (correct)

To negotiate payment amounts with each trial subject individually.

To ensure payments are only made upon trial completion.

To decide the payment schedule without involving subjects.

How should the IRB/IEC document its activities?

By complying only with institutional requirements.

By submitting reports to the trial sponsors.

By maintaining verbal records of discussions.

By recording minutes of its meetings in writing. (correct)

What role does the investigator have in the IRB/IEC meetings?

The investigator may provide information but should not contribute to deliberations. Signup and view all the answers

What is a required minimum composition of members for the IRB/IEC?

At least five members. Signup and view all the answers

Why must the IRB/IEC follow written operating procedures?

To ensure consistency in decision-making. Signup and view all the answers

What is the purpose of inviting nonmembers with expertise to the IRB/IEC?

To gain specific insights that enhance the review process. Signup and view all the answers

What must the IRB/IEC ensure regarding the payment schedule to trial subjects?

It should be prorated and included in the informed consent form. Signup and view all the answers

What must the sponsor provide to the investigator/institution prior to entering an agreement?

An up-to-date Investigator's Brochure and trial protocol Signup and view all the answers

What agreement must the investigator/institution give to conduct the trial?

Compliance with Good Clinical Practice and regulatory requirements Signup and view all the answers

Which of the following is NOT a responsibility of the investigator as per the agreement with the sponsor?

Providing financial support to subjects Signup and view all the answers

What must the sponsor do regarding insurance or indemnification?

Provide insurance except for claims relating to malpractice Signup and view all the answers

What document must be signed to confirm the agreement between the sponsor and the investigator?

The trial protocol or an alternative document Signup and view all the answers

What should the sponsor's policies address in relation to trial-related injuries?

Costs of treatment for trial subjects due to trial-related injuries Signup and view all the answers

What are the financial aspects of the trial required to be documented in?

An agreement between the sponsor and investigator/institution Signup and view all the answers

According to the responsibilities outlined, what is essential for data handling?

Data handling procedures must align with applicable regulations Signup and view all the answers

Who is responsible for monitoring, auditing, and inspection of the trial?

The sponsor and regulatory bodies Signup and view all the answers

What should the sponsor seek before commencing a clinical trial?

Agreement on responsibilities and allocation of duties Signup and view all the answers

What is the primary role of the principal investigator in a clinical trial?

To lead the team of individuals at the trial site Signup and view all the answers

What is required from a legally acceptable representative in a clinical trial?

Authorization under applicable law to consent on behalf of a subject Signup and view all the answers

What does the monitoring process in a clinical trial ensure?

That the trial is conducted according to the regulatory requirements and SOPs Signup and view all the answers

In a multicentre trial, what separates it from a single-centre trial?

It is carried out across more than one site by multiple investigators Signup and view all the answers

What is the purpose of a protocol amendment in a clinical trial?

To describe changes or clarifications to the original protocol Signup and view all the answers

What is the primary focus of the responsibilities outlined in section 3.1?

Protection of trial subjects' rights Signup and view all the answers

Which principle is NOT explicitly covered in the responsibilities of Investigators as per section 4.1?

Record-keeping of protocols Signup and view all the answers

In the context of section 4.2, what is considered necessary for an Investigator?

Adequate resources to conduct trial tasks Signup and view all the answers

Which aspect is addressed under the composition and functions of the IRB/IEC as per section 3.2?

Diverse representation among members Signup and view all the answers

What is NOT included in the responsibilities of an Investigator as specified in section 4.5?

Financial reporting of trial findings Signup and view all the answers

Which of the following responsibilities is specified under section 3.4 regarding IRB/IEC procedures?

Maintaining confidentiality of records Signup and view all the answers

Which section directly addresses the need for communication between Investigators and IRB/IEC?

Section 4.4 Signup and view all the answers

What is one of the main roles of the IRB/IEC as identified in section 3?

Reviewing safety and ethical concerns of research studies Signup and view all the answers

According to section 4.6, what is an essential responsibility of Investigators regarding investigational products?

Ensuring the safety and proper handling of the products Signup and view all the answers

What is the purpose of section 2 in the Guideline regarding the principles of ICH GCP?

Defining ethical frameworks for research Signup and view all the answers

What is the primary responsibility of the sponsor regarding the safety evaluation of investigational products?

To ensure ongoing safety evaluation. Signup and view all the answers

Which of the following must the sponsor promptly notify in cases where safety is adversely affected?

All concerned investigators and regulatory authorities. Signup and view all the answers

What types of adverse drug reactions (ADRs) must the sponsor expedite reporting for?

Serious and unexpected ADRs only. Signup and view all the answers

What is one purpose of trial monitoring as outlined for sponsors?

To ensure the rights and well-being of human subjects are protected. Signup and view all the answers

Who is responsible for appointing monitors in a clinical trial?

The sponsor of the trial. Signup and view all the answers

What qualifications should a monitor have according to the guidelines?

They should possess scientific and/or clinical knowledge pertinent to the trial. Signup and view all the answers

What must the sponsor ensure about the conduct of the trial?

That it complies with the approved protocol, GCP, and applicable regulatory requirements. Signup and view all the answers

What should expedited reports of ADRs comply with?

Applicable regulatory requirements and ICH guidelines. Signup and view all the answers

What is required of the monitors according to their qualifications?

They must have documented qualifications relevant to the trial. Signup and view all the answers

Which of the following is NOT part of the sponsor's responsibilities?

Providing treatment to participants after the trial. Signup and view all the answers

Study Notes

Guideline for Good Clinical Practice E6(R2)

Adoption: Adopted by CHMP (Committee for Human Medicinal Products) on July 23, 2015.
Public Consultation Start: August 4, 2015.
Public Consultation End: February 3, 2016.
CHMP Final Adoption: December 15, 2016.
Effective Date: June 14, 2017.

Document History

First Approval (E6): May 1995.
Step 4 Approval (E6): July 1996.
Step 5 Corrected Version Approval (E6(R1)): July 2002.
E6(R2) Addendum Step 5 Version Adoption: November 9, 2016.

The guideline covers various topics, including Glossary, Principles of ICH GCP, IRB/IEC, Investigator, Sponsor, Quality Management, Data Handling, Clinical Trial Protocol, Investigator's Brochure, and Essential Documents.

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