Good Clinical Practice. Responsibilities, Roles and Governance

Question 1

What are the two main principles of ICH-GCP?

Answer 1

To safeguard the rights and privacy of patients

To ensure credible and valid data

Question 2

What areas do the ICH-GCP guidelines provide rules pertaining to in research?

Answer 2

Designing, conducting, performing, monitoring, auditing, recording, analysing and reporting clinical trials

Question 3

What was the main aim of the revision in 2016 to E6(R2)?

Answer 3

Reflects advancements in technology such as electronic data recording and reporting and the adoption of risk-based approaches to quality management

Question 4

What is the key step in the beginning of a clinical trial that helps to safeguard the rights of patients?

Answer 4

Informed consent

Question 5

List specific committees that have patient responsibility at the fore of their motives?

Answer 5

Data Monitoring and Safety Committee, the Ethics Committee

Question 6

What are the four major GCP components to ensure the rights and safety of patients?

Answer 6

1. Informed consent
2. DMC and Ethics Committees
3. Managing of adverse events
4. Confidentiality

Question 7

How does GCP ensure validity and credibility of the trial?

Answer 7

1. Good design and protocol
2. Development and implementation of SOPs
3. Qualified investigators and staff
4. Data monitoring
5. Data cleaning and validation

Question 8

Give some examples of how SOPs can be used in certain processes in a clinical trial?

Answer 8

Informed consent
How the randomisation is performed
How the treatment is given
How the patient is followed up

Question 9

Who are the four main stakeholders in clinical trials?

Answer 9

1. Future patients and society
   2, Participants in research
2. Academics and scientists
3. Commercial and non-commercial organisations

Question 10

List the different type of responsibilities

Answer 10

1. General or specific
2. Dischargeable or open-ended
3. Conditional or unconditional
4. Binding or optional

Question 11

What document may be submitted to define the rights and welfare of patients in a clinical trial?

Answer 11

Protocol for independent ethics and scientific review

Question 12

How does one determine the scientific validity of the clinical trial?

Answer 12

Ensuring the trial is designed so as yet to yield valid results
Ensuring that the project is feasible in the sense of recruting adequate numbers to answer the research question

Question 13

List some of the responsibilities the investigators have to their trial?

Answer 13

Being adequately trained and qualified
Being familiar with the intervention and up-to-date protocol
Demonstrating there are adequate time and resources to complete the trial
Ensuring staff work by the most up to date protocol
Conducting the project to the agreed protocol in accordance with legal and ethical requirements and guidance
Seeking written voluntary consent
Informing primary care physicians of participation
Recording any reason for withdrawal
Ensuring adequate follow-up
Ensuring any break of randomisation code is done according to the protocol
Making final results available to participants where appropriate

Question 14

What is a sponsor of a clinical trial?

Answer 14

The Sponsor can be an individual, a healthcare organisation such as an NHS Trust, a commercial company, a university, or a combination. The Sponsor takes overall responsibility for confirming that proper arrangements to initiate, manage, monitor and finance the study are in place.

Question 15

What are the main responsibilities of a sponsor?

Answer 15

Design
Regulatory agency notification
Financing
Manufacturing, handling and supplying of medicinal products
Trial management, data handling and record keeping
Convening the trial management group (TMG), Trial Steering Committee (TSC) and DMC
Arranging to compensate trial participants and investigators if necessary
Ensuring quality assurance and control
Reporting of the trial

Question 16

What is the role of the TSC?

Answer 16

Provide input and advice on the trial design
Assist with the development of the study protocol
Monitor and provide overall supervision for the trial

Question 17

What is the role of the DMC?

Answer 17

The DMC assesses the progress of a clinical trial including safety data and the critical efficacy endpoints at intervals defined in the study protocol.

The DMC will review confidential cumulative trial data, formulate a statistical assessment and make recommendations to the TSC after each review, to continue, modify or stop a trial.

The DMC evaluates the risk/benefit ratio and may recommend that a trial be stopped due to safety concerns, a strong efficacy profile in one arm of the trial, or on the basis of futility (i.e. when the probability, given the interim results, that the trial will ultimately be able to demonstrate the effectiveness of the investigational product is very low).

Question 18

Outline the process of ethics approval in the UK

Answer 18

NHS Ethic Committee (RES) - each committee must be recognised by the UKECA (UKECA) to review ethical considerations of a medicinal products