Please read it carefully, feel free to get in touch for any clarification, we will be happy to help you!
The 1st offerings of GCP COMPASS is an Interactive web-based learning tool to learn Good Clinical Practice by understanding theory and relating to practice & more importantly gain an understanding of consequences of not following GCP through some real-life examples.
GCP COMPASS is an organisation to contribute in modernising clinical research by ensuring global requirements and more importantly respecting regional/ local considerations to deliver proactive quality.
All life science university students (e.g. Nursing, Medicine, Pharmacy, Biomedical Engineering), Doctors, Investigators, Clinical/ Research Co-ordinators, Employees of Clinical Research Organizations & Pharmaceutical & Biotech companies.
GCP COMPASS welcomes any organization engaged in the field of clinical research; who would like to use our platform to support skills development of their employees. For specific needs and pricing, please contact info@gcpcompass.com.
GCP COMPASS has introduced a GCP test to test user knowledge using 2 types of test. 1) traditional timed test and 2) An open book policy. The user assessment is then done with data analytics techniques by using speed & accuracy of the user response for each of the questions.
- GCP COMPASS covers broader area of GCP (not just limited to ICH GCP) across key markets
- GCP COMPASS provides most up to date information on GCP areas and all questions are built around not just based on historical information but also on the latest information. Questions are in multiple choice format. These questions are not static and will be refreshed periodically to ensure they are current and in line with latest changes in regulations/guidelines etc.
- GCP COMPASS has introduced a concept of bite-size flashcards, which basically information taken from one of the 13 databases highlighted in green boxes (No. 1-13). The flashcards will help users to learn topics bite by bite without too much information overload at one time.
- GCP COMPASS has proactive questions written in way to learn GCP in a fun & interactive manner without taking burden of classroom/learning exam style environment. In addition to that, tool has also connected any publicly known inspection findings associated with this area so that user will know the consequences of not following GCP in terms of data integrity, patient safety.
- The users will have ability to see their own progress through an interactive “Talent Profile” build & designed with advanced analytical techniques and then personalized for each individual user. More importantly, it will not be static and therefore; as you attempt more questions, it will show you real time progress and also direct which areas you have done well and which areas you will need to focus on before attempting test.
- ICH Guidelines for Good Clinical Practice E6 R (2)
- EMA guidelines for Good Clinical Practice E6 R (2)
- MHRA guidance for the notification of Serious Breaches of GCP or the Trial Protocol
- Electronic Records; Electronic Signatures (21 CFR Part 11)
- Protection of Human Subjects (Informed Consent) (21 CFR Part 50)
- Financial Disclosure by Clinical Investigators (21 CFR Part 54)
- Institutional Review Boards (21 CFR Part 56)
- WHO Handbook for Good Clinical Practice
- HIPPA regulations
- GDPR
- Ongoing regulatory guidance available from EMA, US FDA & MHRA on managing clinical studies in the COVID-19 crisis
We have currently launched web-based application of our VLE platform. This can still be accessed and used with mobile device. In the near future, we are planning to launch android and iOS based mobile application and will publish details on our website to keep users updated.
All information in flashcards used, questions prepared and used in our Virtual Learning Platform are adapted from the information available in regulatory guidance documents and details of these guidance can be found on our “Useful links” sections. We have taken reasonable steps to ensure accuracy of the information included in our flashcards and question databases.
We have extensively reviewed all our flashcards & question databases as a part of validation process with our experts in the field of clinical research. If you come across any discrepancies, please let us know by writing email @ info@gcpcompass.com & we will rectify that as soon as possible.
It is our endeavor to ensure all information on flashcards & GCP questions is up-to-date and in line with changes in regulatory guidance. We suggest user to refer to the regulatory guidelines related to good clinical practices by visiting regulatory websites in case they see any conflicting information and information on such regulatory websites should be treated as authentic.
All membership types of GCP COMPASS will give you access to practice questions. In some membership, you will have an option to see your own progress through an interactive dashboard so that you will know, along the way, the areas within GCP, you have understood well and also areas that you will need to focus on to enhance your skills.
Some membership will have option to appear for a test and get your certification. Please visit our Membership page on GCP COMPASS website for details of membership and what is/is not covered in each membership.
Yes. This is possible. We can work with your organization to customise any specific tests/ solutions. Please write to us @ info@gcpcompass.com with your detailed request and GCP COMPASS representative will contact you to discuss your needs.