Why is GCP such an important discipline, what impact does it have on clinical trials and why does it’s training need to be relevant and engaging?
Why is GCP such an important discipline
Good Clinical Practice is a guideline written by ICH, helping all people supporting the conduct of clinical trials with a medicinal product to deliver high-quality data.
The ICH organization brings together health regulators and the pharmaceutical industry from all regions. Resulting in the harmonization of the requirements for drug development and registration worldwide.
Having high-quality clinical data ensures the usability of the clinical data and the safety of the new treatment: whether it can prove a new drug is a better treatment than the current standard, whether it is safe to use in humans. The trustworthy, GCP compliant documented data enables regulators to review the documented proof of the new treatment and allows new drug registrations in their regions.
GCP knowledge, therefore, is required for all staff working on trials with medicinal products, including nurses documenting the adverse events, laboratory staff analyzing the trial samples, pharmacy staff preparing the administration of the medicines and the data managers/medical writers creating the final report for the trial.
The GCP guideline states,
“Staff have appropriate knowledge, experience and training for the role and responsibilities assigned to them”
What Impact on clinical trials and advancements in medicine does GCP have?
Working according to GCP also enables data to be used and accepted in other regions in the world: official ICH regions are Europe, Japan, USA, Brasil, China, Singapore, Korea, Taipei, Canada, and Switzerland. Trials done according to GCP will be accepted by the governments of these countries, which helps to spread new treatments for patients around the globe.
Why is it so important to make GCP training content relevant and engaging?
GCP is a regulatory guideline, meaning the content was created by regulators, legal associates and subject matter experts.
Such content is not always easy to read and implement for clinical research professionals. By interviewing research professionals, we have translated the GCP guideline and local legislation to the day-to-day practice of a research professional.
Learning about GCP in a recognizable context and with the use of active assignments, questions and learning activities improves the retention of the learning material and enables them to use the GCP rules they learned in their daily practice. Good quality clinical research is the result.
The content and scope of the GCP training should be made relevant per role in clinical research, to prevent staff learning inefficiently and getting demotivated by the number of rules they need to learn, which they will never use in their job.
Depending on the delegated activities to a staff member in the trial, the GCP training should be adjusted to explain the requirements for those activities only.
Sufficient and relevant training keeps staff focused and motivated. Tailoring training to the needs of staff to ensure they have the necessary knowledge for the quality conduct of clinical trials.
Interestingly, the frequency of GCP Training has not been established by the regulatory bodies, meaning that each organization needs to define and set when updates to the training are required, whilst being conscious to changes to GCP regulations or guidance.
Why are our myGCP users so engaged?
Our online training is efficient, flexible and fun.
We allow our students to log in where ever and whenever they like, using their laptop, smartphone or tablet.
Flexibility is also supported by the modular setup of the course, allowing users to complete learning bites of 10 minutes and tracking continuous progress to allow them to start and stop learning whenever they like.
We offer shorter GCP courses tailored to the needs of support staff in clinical trials, making the training efficient and relevant for all.
Want to know how we can change the future of GCP learning? Sign up for a demonstration here.