Blog – GCP Training: Do We Really Need Regular Refreshers?

This blog explains why Good Clinical Practice (GCP) Training is so important, what went wrong in the past and why this matters for people living with dementia and other neuroprogressive conditions today.

In my role as strategic manager with both ENRICH Scotland and the Neuroprogressive and Dementia Network (NDN), I still require to have GCP updates on a two yearly basis. This is something which I can’t say I look forward to and wonder if I really need to do this – so I decided to look into why this is necessary, a bit more deeply.

We all appreciate that when people take part in research—whether that’s a clinical trial for a new dementia treatment or helping us understand how conditions progress—they are doing something incredibly important.

Unfortunately, history has shown that research can go badly wrong if it is not done ethically and carefully. That is why we now have GCP, which is a set of rules designed to protect people, especially those who may be vulnerable.

In simple terms, GCP is a set of international standards that make sure research is safe, ethical, respectful and trustworthy. It ensures that people understand what they are agreeing to, risks are carefully managed, participants are treated with dignity and the results of research are reliable. For us as researchers and clinicians, GCP training and ongoing updates are how we learn to do this properly.

Why does GCP training matter for people with dementia?

People with dementia or neuroprogressive conditions may find it harder to process complex information, rely on carers or family for support and may be more vulnerable to pressure or misunderstanding. Because of this we have to take extra care to communicate slowly and clearly, check the person’s understanding of what is being asked of them, respect their choices even when it means they decide to not go ahead in the research offered and involve carers, nearest relatives or even welfare guardians where appropriate. GCP training helps us to do all of this in a structured, consistent way.

Where the rules came from

Modern research rules did not appear overnight. They were created because of serious failures—some of the worst during World War II. During the 1930s and 1940s, doctors working under Nazi rule carried out cruel and dangerous experiments on prisoners without their consent. People were forced into studies and exposed to extreme conditions, disease and harm. These prisoners were treated as objects rather than human beings. There was no choice, protection or rules and no respect for life or dignity. These events showed what can happen when science is allowed to override basic human rights.

The key lessons from the failures are that the world recognised several fundamental problems.

1. People must be able to choose: No-one should ever be forced into research and today, we call this Informed Consent.
2. Peoples’ wellbeing must come first: Research should never deliberately harm people or ignore their suffering.
3. Vulnerable groups need extra protection: people who are ill, disabled or dependent on others must be safeguarded.
4. There must be clear rules and oversight: at the time there were no global standards – researchers could act without accountability.

After these horrific events, the Nuremberg Code (1947) was created. It set out essential rules, including: Consent must be voluntary, research must minimise harm, participants can withdraw at any time. Over time, these ideas developed into modern systems like GCP.

What GCP training covers today

Our modern version of GCP training ensures that lessons from the past are not forgotten. It teaches us how to put people first, not the study; explain research clearly and honestly; respect participants’ wishes at all times; monitor safety and respond quickly to concerns; keep data accurate and trustworthy. It also helps build public trust so people feel confident taking part in research.

For research in dementia or any of the Neuroprogressive conditions and for people living within a care home research GCP has real, practical benefits such as:

• Clear communication. Information is presented in ways that are easier to understand.
• Respect for changing capacity. If someone’s ability to consent changes, their wishes are continually reviewed.
• Involvement of carers and families. Support networks are recognised as part of ethical decision-making.
• Ongoing consent. It’s not just a one-off signature—people can leave a study at any time.
• Focus on dignity and quality of life. Research is designed to minimise distress and maximise benefit.

GCP exists because history showed us what can happen when research is done without ethics.

Today, thanks to these lessons:

• People are protected
• Rights are respected
• Research is safer and more meaningful

For the dementia and neuroprogressive community, this is especially important.

Taking part in research should always feel like a choice—and a positive contribution—not something that puts your safety or dignity at risk.

What changed in my latest GCP training update

Back to why bother with GCP updates here are some of the things I learned on my latest update. There has been a change in terminology:

• Subjects become participants
• Trial site becomes trial location
• Essential documents become essential records
• Amendment becomes a modification

Source data documents have been updated to reflect the digital world we live in and we can now include all of the data detailed below:

• Participant Health records
• Data entered by participants
• Imaging data and scan reports
• Lab test results
• Digital data from wearables or sensors
• Participant questionnaires
• Record of drug administration
• Real world data – data collected from health care sources outwith the study.

And where data can be compromised:

• Sample integrity – Sample collection SOPs – all staff to know what they are
• Incorrect labelling – Using handwritten details rather than barcode
• Not having a record of time of collection
• Deviation from shipping temperature instructions
• Failure to log chain of custody information
• PI is responsible for all data collected but it is the team’s individual responsibility for delegated duties

And this acronym helps to remember some of the important points with all data sources wherever they come from:  ALCOA+ Attributable, Legible, Contemporaneous, Original, Accurate plus complete, secure and reliable

So back to my original question – Do we really need this training including the updates?

A resounding Yes:

• Because real people are involved, not just spreadsheets. GCP helps keep participants safe and ensures the data actually means something.
• Because trials have changed a lot. We’ve moved from paper-based, clinic-only studies to remote monitoring, wearables, and people taking part from home.
• Because new technology brings new risks. We now need clear guidance on who is responsible for remote data and how it’s managed.
• Because ‘good enough’ data isn’t good enough. Updates help ensure results are reliable, meaningful, and built on quality from the start.
• Because research keeps moving. Guidance needs to keep pace with innovation so new treatments can reach people efficiently.
• And because your old training is out of date. New expectations and responsibilities mean refreshers are genuinely needed.

So are training and updates necessary? Absolutely. They help protect participants, improve research, and maintain trust. Next time someone asks if you’ve done your GCP or your refresher, show them your certificate and smile!

Dr Emma Law

Author

Dr Emma Law is Strategic Manager for the Neuroprogressive and Dementia Network in Scotland. Emma has 13 years experience as a Clinical Trials Network Manager and over 35 years experience as a Nurse, many of which were spent in the delivery of Clinical Research Trials. Emma completed her PhD and is passionate about giving people living with dementia and their carers access to participate in research.