Good Clinical Practice Flashcards
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
ICH-GCP
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 Investigator Sponsor 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 Monitoring Communication
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) Interviews 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
