Good Clinical Practice

Question 1

What is GCP?

Answer 1

Ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human guidelines
It can be regarded as total quality management of clinical trials procedures

Question 2

Why is GCP needed? Why has it developed into formal guidelines?

Answer 2

To ensure the rights, safety and wellbeing of the trial subjects are protected
Ensure the credibility of clinical trials data
Public disasters, serious fraud and abuse of human rights

Question 3

GCP Guidelines

Answer 3

Mainly focus on the protection of human rights in clinical trial
Provide assurance of the safety of new compounds
Provide standards on how clinical trials should be conducted
Define the roles and responsibilities of clinical sponsors, clinical research investigators, clinical research associates and monitors
Are defined as an international ethical and scientific standard for designing, conducting, recording and reporting trials that involve the participation of human rights

Question 4

GCP principles

Answer 4

In accordance with Declaration of Helsinki, consistent with regulatory requirements, benefits outweigh risks, rights, safety and welfare of human subjects take priority, scientifically sound, ethically approved protocol, medical care given, training, informed consent, recorded, confidentiality, quality of data

Question 5

Declaration of Helsinki

Answer 5

A series of non-legal guidelines that medical researchers should adhere to
Developed by the World Medical Association, June 1964
Morally binding, obligation overrides any national or local laws or regulations, if the declaration provides for a higher standard of protection of humans than the latter
Forms the basis of ICH-GCP, which aims to standardise and rationalise clinical research
Covers all medical research
Most recent amendment October 2013

Question 6

ICH-GCP

Answer 6

Recognised that different countries had different approaches to medical research
This led to patients being exposed to more risk and was expensive as research had to be repeated many times
ICH is the international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use
Based on protecting study participants, ensuring sound science and verifying results using appropriate statistics

Question 7

ICH definition

Answer 7

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected

Question 8

The objective of ICH GCP guidelines

Answer 8

Developed with consideration of the current good clinical practices of the European Union, Japan and USA, plus those of Australia, Canada, the Nordic countries and WHO
Provide a unified standard for the European Union, Japan and USA to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions

Question 9

ICH GCP guidelines cover…

Answer 9

Ethics committee
Investigator
Sponsor
Clinical trial protocol and amendments
Investigator's brochure
Essential documents for conduct of a trial

Question 10

NHS Research Governance Framework for Health and Social Care

Answer 10

The framework covers:
Research by staff with trust and honorary trust contracts
Research involving patients, service users, care professionals, volunteers or their organs, tissues or data
Research funded by the NHS
Research using facilities funded by the NHS

Question 11

Aims of the framework

Answer 11

To promote a quality research culture
To promote excellence
To provide strong leadership for research
To implement standards: set out in legislation and regulations, required by the department of health, established as good practice

Question 12

Principal investigator/research team responsibilities

Answer 12

Understand protocol
Record data
Equipment maintenance
Training staff
Record of recruitment
Protect participants
Product Accountability
Safety reporting
Lab evaluations
Site file
Monitoring
Communication

Question 13

What is consent?

Answer 13

Legal requirement- informed consent is an ongoing agreement by a person to receive treatment, undergo procedures or participate in research. after risks, benefits and alternatives have been adequately explained to them

Question 14

When to take consent

Answer 14

Prior to any research related procedure:
Questionnaires (assumed)
Interviews
QoL data
Sample taking
Interventional research procedures etc.

Question 15

How to take consent

Answer 15

Discuss: dedicated time, no interruptions, ask questions, timing and time to think (24 hours)
Written information: participant information leaflet, involving people, sources of further information, particular requirements- vulnerable adults and children
Consent form: not a one off event, initial boxes, 3 copies, participant sign and date

Question 16

Consenting vulnerable patients

Answer 16

Those subjects who cannot read or write, or who are otherwise unable to give consent for themselves due to young age or mental incapacity are considered vulnerable
Prisoners also require special attention
Clinical trials that do not confer a direct clinical benefit to a subject should not be conducted on vulnerable subjects unless the objectives can’t be met by trials on non-vulnerable patients
Subjects in these trials should be particularly closely monitored and should be withdrawn if they appear to be unduly distressed

Question 17

Scientific/peer review

Answer 17

Every proposal for health and social care research must be subjected to review by experts in the relevant fields able to offer independent advice on its quality
Should be independent, expert and proportionate

Question 18

Trial information- key points

Answer 18

There should be free access to information on research being conducted and research findings
Results should be published in a format understandable to the public
Findings should be made available to participants via clinical trial database

Question 19

Protocol and project documents

Answer 19

Protocol- full description of the research, including title, abstract, rationale, aims, methods, ethical consideration, benefits, resources and costs
Participant information sheet and consent form- follow the guidance provided by HRA
Supporting documents- costs, agreements, laboratory instructions, scientific review

Question 20

Ethical review- key points

Answer 20

Research involving patients, service users, care professionals, volunteers or their organs should be independently reviewed by an ethics committee
Consideration should be given to the dignity, rights, safety and well being of participants
Participants should give informed consent
Participant data should be protected
Consumers should be involved in research
Diversity of human culture should be respected

Question 21

Study master file

Answer 21

Maintain documents which individually or collectively allow for an evaluation or audit of the conduct of your research and the quality of the data produced
Version control is a key part

Question 22

Adverse event reporting

Answer 22

Will depend upon the trial and be defined in the protocol
Generally any AE or SAR should be recorded in the patient notes and case report form and reported to the PI at the study site
The PI determines whether the AE or SAR is serious
The PI informs the chief investigator of any SAE or SUSAR
The chief investigator will report any SAE or SUSAR to the trial sponsor, data monitoring committee, MHRA and or ethics committee, as specified in the protocol