Quality of care is a major topic in health and social care, and Good Clinical Practice ensures that quality and safety is maintained to a high standard during all clinical trials involving human percipients.
The NHS Health Research Authority (HRA) defines Good Clinical Practice (GCP) as:
“a set of internationally recognised ethical and scientific quality requirements that must be followed during all stages of a human clinical trial. This refers to when designing, analysing, and conducting the clinical research.”
The GCP requirements are in place to protect the ethical rights, safety, confidentiality, and wellbeing of all the individuals involved. They have been developed over time to ensure the continuous improvement of trial methods and results.
What are GCP guidelines?
The ICH has developed principles for Good Clinical Practice (ICH-GCP) to be followed by all member states. To summarise:
- All clinical research should be conducted honouring ethical principles. Respect, beneficence, and justice all must be considered.
- Before a clinical trial, all potential risks need to be thoroughly assessed and considered. The impact of a trial needs to outway the risks to justify the trial from taking place.
- Clinical investigators should question how the results benefit the subject, wider society, and/or contribute to science.
- The rights, safety, and wellbeing of the human subjects must always be highly priortised over all else.
- All trials should be scientifically sound and evidence clear protocols.
- All medical care must be accessible and offered by qualified professionals with adequate experience and knowledge.
- A trial should be approved by the institutional review board (IRB)/independent ethics committee (IEC).
- Records must be easily accessible for accurate reporting and interpretation to ensure that the data and results are credible.
- All data and information must be handled and stored safely and securely. Protecting the confidentiality and privacy of a subject and their ability to be identified is essential.
- All human subjects involved in a trial should be educated and trained to complete their task(s).
- Investigational equipment should be compliant with applicable good manufacturing practices (GMP).
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Who needs to consider GCP?
Any organisation that needs to conduct face-to-face trials involving people must comply with GCP. This includes, but is not limited to:
- pharmaceutical companies,
- contract research organisations,
- NHS organisations and hospitals,
- charities, GP practices,
- and laboratories.
How to get a good clinical practice certification?
It is crucial for anyone partaking in the trial to acquire the right training to perform tasks safely.
GCP training and courses are required by the UK Policy Framework for Health and Social Care Research. This requirment was developed by the Health Research Authority for researchers conducting clinical trials of investigational medicinal products (CTIMPs).
Non-clinical trials do not need to be compliant with GCP. However, it is advised that researchers still consider the requirements during any trial for safety precautions.
There are many online and face-to-face GCP training opportunities.
How can technology help?
Radar Healthcare’s award-winning software centralises all quality and compliance processes to help healthcare services deliver safer care. Find everything from audits and workforce compliance, to incident management and more. We’re dedicated to helping healthcare organisations improve their services. If you’d like to find out more, book a demo to see our software in action.