GCP for the beginner by Kim Appleton


Kim Appleton

GCP or Good Clinical Practice is a set of standards by which all clinical research is regulated. The World Health Organisation describe GCP as a “process that incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects. “

I could go into great detail about the European Clinical Trials Directive 2001/20/EC http://ec.europa.eu/health/human-use/clinical-trials/directive/index_en.htm and the ICH GCP guidelines http://www.ich.org/products/guidelines.html  but that would be a bit dry so if you are looking for more info, check out the links. Glasgow Clinical Research Facility http://www.glasgowcrf.org.uk/ run some great courses (required training if you are working on a clinical trial) that explain the day to day requirements.

What it boils down to for the average researcher is writing EVERYTHING down, never throwing anything out and being buried under a mountain of paperwork. The reward however, is an overall feeling of overwhelming smugness when you can lay your hands on a requested document in under 30 seconds without the usual panicked rummaging.

I have a biology background so my GCP experience began in a wet lab. I was most resistant at first as everything takes ages. Rather than just getting on with an experiment I had to spend time proving that every piece of equipment was fit for purpose, all samples were prepared the same way, every reagent was within date and certified, and all my raw data was dated and correspond to the final results.

Again, the rewarding smugness when you present your lovely results and can defend any criticism is very nice but when your results turn out to be negative and your colleague has generated enough data for 3 papers in the same time it can be a bit disheartening.

As a trial coordinator my day to day role has changed but the same principles apply to the lab. Samples are now participants in the study that I have to show that all received the same intervention and they have to have the correct documentation (consent forms, etc); reagents and equipment are manuals and therapists that comply with the trial protocol and have training records; and raw data comes in CRFs (Case Report Forms) completed (or not) by therapists and researchers.

While this all sounds very onerous and time consuming, I am now a great advocate for GCP and these regulations. It’s difficult when we are all pushed to generate results as quickly as possible, to “waste” time on protocols and paperwork, but it ensures that the results we produce are accurate and meaningful. I cringe when I remember how I used to work in the lab –writing experiments up weekly, delaying adding a reagent by 5 minutes so I could grab a tea-break, using a colleague’s buffer (maybe she’d left out of the fridge over night by accident) or using a buffer that had expired yesterday because it takes 3 hours to make a new batch and its 4pm. While this admission might render me unemployable as a lab scientist again, all of these things happen in labs all the time and can make a difference to a result if the protocol is particularly sensitive.

I think my biggest piece of advice to anyone doing clinical research, is to be able to demonstrate that any small deviations from the protocol (a trial protocol or an SOP) are recorded and dealt with in the correct way. For me, this could be something as simple as a change made on a CRF to something more significant such as a patient that has been included in the study incorrectly. As long as there is evidence (emails, letters etc) for any decision that’s made and this evidence is kept with the relevant document then it should be easy to defend.  At the time you always think you’ll remember why you did whatever it was, but six months down the line the issue will have merged with a hundred other decisions, and you will NEVER find that email that explains it.