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Flashcards in Good Clinical Practice Deck (22):

What is GCP?

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


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

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


GCP Guidelines

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


GCP principles

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


Declaration of Helsinki

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



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


ICH definition

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


The objective of ICH GCP guidelines

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


ICH GCP guidelines cover...

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


NHS Research Governance Framework for Health and Social Care

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


Aims of the framework

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


Principal investigator/research team responsibilities

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


What is consent?

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


When to take consent

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


How to take consent

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


Consenting vulnerable patients

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


Scientific/peer review

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


Trial information- key points

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


Protocol and project documents

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


Ethical review- key points

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


Study master file

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


Adverse event reporting

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