In the world of Good Clinical Practice, what does it mean when a Training Provider claims to have “TransCelerate acknowledged” GCP training? Our questionnaire shows not many investigators, CRAs and site staff are aware of the existence and added value.
What is TransCelerate?
TransCelerate is a non-profit organization that creates effective, innovative solutions for the biopharmaceutical industry. Member companies, who are biotech and pharmaceutical companies, have helped develop guidelines to give hospitals and their investigators peace of mind when it comes to choosing GCP Training Providers. All providers who can measure their minimum criteria are provided in a list, which should be considered by ICH GCP training.
GCP Central is proud to be one of the early supporters of the TransCelerate GCP mutual recognition program. Our first TransCelerate acknowledged ICH-GCP training course launched in March 2013, less than one year after the initiative was born.
Seven years after the implementation of the GCP mutual recognition program and eleven approved courses later, we are excited to announce that GCP Central has received a renewal of the TransCelerate acknowledgment as necessary after the ICH-GCP R2 update of our courses. This update was essential in order to remain compliant and up to date.
GCP Central and TransCelerate
We want to reduce the time spent on GCP training. We believe that initiatives like TransCelerate make the lives of researchers, clinicians, and their staff, easier. This is by increasing the efficiency of (and preventing bureaucracy) during site initiations and trials.
Being a listed Training Provider on the TransCelerate BioPharma website with various approved courses ensures that our trained investigators and site personnel do not have GCP training at the beginning of each trial. Instead, it is unnecessary to repeat a GCP course within the trial, especially when you use our continuous GCP learning model.
With investigators conducting trials for multiple sponsors, our universally accepted GCP training program does not have to be repeated. Researchers can get out of business at hand – conducting quality research and improving human health.
In October 2018 we have Conducted internal company audit and micro questionnaire with 250 clinical research professionals who are both on the internet and on my LinkedIn learning platform. The goal was simple, we wanted to check whether the TransCelerate program goals are sufficient.
We presented our findings in November 2018 at the NVFG presentation at the ClinOps meeting.
Key Findings
- More than 50% of respondents said they had to attend 2 or more GCP training sessions in the last three years. A small group of 14 respondents had to take more than 5 GCP training in the previous three years. This is 2 per year. Duplicating GCP training is unnecessary and precisely what TransCelerate would like to prevent.
- 85% of our respondents working in hospitals are not familiar with TransCelerate.
- 37.5% of respondents think the goal of TransCelerate is to provide certification to GCP Training Providers or perform a quality check on training contents. (81% of this 37.5% is work in hospitals or universities)
- 74% of respondents do not check for TransCelerate acknowledgment when choosing a GCP training/training provider. Of the people who do not test for acknowledgment work at a hospital or university.
Key Points
For us, the main point we took away from the survey was that the GCP Mutual Recognition program or TransCelerate is not aware of the GCP Mutual Recognition program. This information is critical, the TranCelerate member companies and the TransCelerate organization need to spread the work and the benefits.
How can we make better use of the TransCelerate Mutual Recognition Initiative?
In our opinion, to build upon the current success of TransCelerate, all pharmaceutical, and biotech companies should be motivated to be part of TransCelerate. To date, nineteen pharmaceutical companies are part of TransCelerate and many other organizations have a partnership with TransCelerate providing valuable insights.
Mentioning the TransCelerate membership, and its implications, in SOPs and Policies could increase the understanding and adherence to the TransCelerate Initiatives. This helps to prevent duplication of GCP training by site staff and clinicians, and increases the speed of initiation of sites, helping to get research results and data quicker. We should also be investigators, clinicians and site staff aware of the existence and goal of TransCelerate Mutual Recognition.
We encourage TransCelerate, the GCP Training Providers, pharmaceuticals, biotech companies, and all partners such as CROs to spread awareness to improve clinical trials and motivated site staff. .The success of this initiative is in the collaboration between sponsors and investigators, let’s help each other to make the process more efficient.
The findings of our mini questionnaire prove that more needs to be done to support and continue the innovative work of TransCelerate and similar projects.
GCP Central likes to be at the forefront of changes in the clinical research industry. We want to make clinical trials smarter and faster. By being TransCelerate acknowledged, helping to spread the word among investigators, and by being actively involved in initiatives.
Want to see more about our questionnaire results and the opportunities we see for TransCelerate? Read it in our next blog about TransCelerate.
