ICH GCP E6(R2)

Question 1

Front: What does ICH stand for in ICH GCP E6 R2?

Answer 1

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Question 2

What is the purpose of ICH GCP E6 R2?

Answer 2

ICH GCP E6 R2 provides a unified standard for the design, conduct, monitoring, auditing, recording, analyzing, and reporting of clinical trials.

Question 3

Explain the concept of Risk-Based Monitoring (RBM) in ICH GCP E6 R2.

Answer 3

RBM focuses monitoring efforts on areas with the highest risk to patient safety and data integrity.

Question 4

What is the role of the Clinical Research Associate (CRA) in ICH GCP E6 R2?

Answer 4

The CRA monitors the conduct of a clinical trial to ensure compliance with the protocol, GCP, and applicable regulatory requirements.

Question 5

Define Essential Documents according to ICH GCP E6 R2.

Answer 5

Essential Documents are those that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced.

Question 6

What is the purpose of the Investigator’s Brochure in ICH GCP E6 R2?

Answer 6

The Investigator’s Brochure provides comprehensive information on the investigational product to support the conduct of the trial.

Question 7

Explain the principles of informed consent according to ICH GCP E6 R2.

Answer 7

Informed consent should be obtained freely, and subjects should be provided with adequate information to make an informed decision.

Question 8

Describe the responsibilities of the Sponsor in ICH GCP E6 R2.

Answer 8

The Sponsor is responsible for the proper conduct of the trial and ensuring the rights, safety, and well-being of the subjects.

Question 9

What is the purpose of the Protocol in ICH GCP E6 R2?

Answer 9

The Protocol outlines the objectives, design, methodology, statistical considerations, and organization of a clinical trial.

Question 10

What is the role of the Data Monitoring Committee (DMC) in ICH GCP E6 R2?

Answer 10

The DMC is an independent group that monitors patient safety and treatment efficacy during a clinical trial.

Question 11

Explain the concept of Quality Management in ICH GCP E6 R2.

Answer 11

Quality Management involves systematic processes to ensure that trials are conducted and data are generated, documented, and reported in compliance with GCP and regulatory requirements.

Question 12

Define the term “Monitoring Plan” according to ICH GCP E6 R2.

Answer 12

A Monitoring Plan outlines the strategy and procedures for monitoring clinical trials, including the frequency and extent of monitoring visits.

Question 13

Describe the concept of Electronic Data Capture (EDC) in ICH GCP E6 R2.

Answer 13

EDC involves the collection of clinical trial data using electronic systems rather than paper-based methods.

Question 14

What are the key principles of ICH GCP E6 R2 regarding the Investigational Product?

Answer 14

-Allows the delegation of study drug dispensing, patient counseling, and drug accountability.
-Requires that the Investigator maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all IP received from the sponsor.
-Prohibits the sponsor (or CRO) from providing IP until all required documentation for the IRB has been obtained.

Question 15

What is the role of the Independent Ethics Committee (IEC) in ICH GCP E6 R2?

Answer 15

The IEC reviews and approves the clinical trial protocol and safeguards the rights, safety, and well-being of human subjects.

Question 16

Explain the concept of Sponsor Oversight in ICH GCP E6 R2.

Answer 16

Sponsor Oversight involves the sponsor ensuring proper conduct of the trial, including monitoring and quality control.

Question 17

Define the term “Audit Trail” in the context of ICH GCP E6 R2.

Answer 17

An Audit Trail is a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events.

Question 18

Describe the role of the Clinical Trial Protocol in ICH GCP E6 R2.

Answer 18

The Protocol is a detailed plan of a clinical trial, outlining the objectives, design, methodology, and statistical considerations.

Question 19

What is the purpose of the Site Selection Visit in ICH GCP E6 R2?

Answer 19

The Site Selection Visit helps assess the suitability of a site to conduct a clinical trial, considering facilities, staff, and patient population.

Question 20

Explain the concept of “Risk Assessment” in ICH GCP E6 R2.

Answer 20

Risk Assessment involves identifying and treating potential risks to subjects, data integrity, and overall trial quality.

Question 21

What is the purpose of the Trial Master File (TMF) in ICH GCP E6 R2?

Answer 21

The TMF is a collection of essential documents that provides a comprehensive record of the conduct of a clinical trial.

Question 22

Define the term “Adverse Event” in ICH GCP E6 R2.

Answer 22

An Adverse Event is any untoward medical occurrence in a subject, including symptoms, signs, and laboratory findings.

Question 23

What are the reporting requirements for Suspected Unexpected Serious Adverse Reactions (SUSARs) in ICH GCP E6 R2?

Answer 23

SUSARs must be reported promptly to regulatory authorities, the IRB/IEC, and investigators.

Question 24

Explain the concept of “Clinical Trial Monitoring” in ICH GCP E6 R2.

Answer 24

Clinical Trial Monitoring involves overseeing the conduct of a clinical trial to ensure compliance with the protocol and GCP.

Question 25

Describe the responsibilities of the Principal Investigator (PI) in ICH GCP E6 R2.

Answer 25

The PI is responsible for the conduct of the trial at the trial site and ensures compliance with the protocol and regulatory requirements.

Question 26

What are the principles of ICH GCP E6 R2 regarding Data Integrity?

Answer 26

Data should be accurate, complete, and reliable, and data integrity should be ensured throughout the trial.

Question 27

Explain the concept of “Protocol Deviation” in ICH GCP E6 R2.

Answer 27

A Protocol Deviation is a change or divergence from the study protocol, and deviations should be documented and explained.

Question 28

Define the term “Serious Adverse Event (SAE)” in ICH GCP E6 R2.

Answer 28

A Serious Adverse Event is an adverse event that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability.

Question 29

What is the purpose of the Investigator’s Responsibilities in ICH GCP E6 R2?

Answer 29

The Investigator is responsible for conducting the trial in accordance with the protocol, GCP, and applicable regulatory requirements.

Question 30

Explain the concept of “Clinical Trial Authorization” in ICH GCP E6 R2.

Answer 30

Clinical Trial Authorization refers to obtaining approval from regulatory authorities before initiating a clinical trial.

Question 31

Describe the concept of “Study Endpoint” in ICH GCP E6 R2.

Answer 31

A Study Endpoint is a specific event or outcome used to measure the efficacy or safety of a treatment in a clinical trial.

Question 32

What is the purpose of the Clinical Trial Protocol Deviation Log in ICH GCP E6 R2?

Answer 32

The Protocol Deviation Log documents any deviation from the study protocol and provides a record for monitoring and auditing purposes.

Question 33

Define the term “Interim Analysis” in the context of ICH GCP E6 R2.

Answer 33

Interim Analysis involves the analysis of accumulating study data before the study is completed, often for safety or efficacy assessment.

Question 34

What is the role of the Sponsor’s Monitor in ICH GCP E6 R2?

Answer 34

The Sponsor’s Monitor oversees the conduct of the trial at investigational sites to ensure compliance with the protocol and GCP.

Question 35

What are the principles of ICH GCP E6 R2 regarding Subject Safety?

Answer 35

The well-being of subjects should always take precedence over the interests of science and society.

Question 36

Explain the concept of “Randomization” in ICH GCP E6 R2.

Answer 36

Randomization is the process of assigning subjects to different treatment groups in a randomized controlled trial.

Question 37

Describe the principles of ICH GCP E6 R2 regarding Confidentiality of Records.

Answer 37

The confidentiality of subjects’ records should be maintained in accordance with applicable regulatory requirements.

Question 38

What is the purpose of the Informed Consent Form in ICH GCP E6 R2?

Answer 38

The Informed Consent Form provides subjects with information about the trial and seeks their voluntary agreement to participate.

Question 39

Explain the concept of “Good Clinical Practice” in ICH GCP E6 R2.

Answer 39

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials.

Question 40

Describe the principles of ICH GCP E6 R2 regarding the Conduct of Clinical Trials.

Answer 40

Clinical trials should be conducted in accordance with ethical principles, regulatory requirements, and the protocol to ensure the rights, safety, and well-being of subjects.