There is a huge amount of information and training on the European Medicines Agency (EMA) website to support organisations and individuals who will use the Clinical Trials Information System (CTIS) from January 2021. Here I just want to focus on a few key things you need to be aware of and then point you to the training provision available.
1) Transition Period. There does seem to be some confusion around when we are REQUIRED to start using the system for clinical trial applications. My understanding is as follows:
a) The transition period is three years from the date of application of the Clinical Trials Regulation (CTR), which is 31 January 2022.
b) Any ongoing clinical trials which will continue beyond this period (31 January 2025) must be transferred to the CTR.
c) For new clinical trials there is a one year transition period, so up until the 31 January 2023 the sponsor can decide whether to run the trial under the old directives or the new CTR, providing the trial will be finished before 31 January 2025.
d) After one year (31 January 2023) all new clinical trials must run under the CTR.
2) Registration. The CTIS is split into different functions and sponsors and other organisations need to work out which user roles and personas they will need to assign within their organisation.
a) Registration for Individuals. In order to use the system each person will need an active EMA account. You can register yourself if you don’t already have an account.
b) Registration for Sponsors. Sponsors will need to register as an Organisation and there are two High-Level administrator roles, a Sponsor Users administrator and a Marketing Authorisation Holder administrator. These administrator roles will be able to assign and support users for that organisation.
3) User Roles. There are two approaches to using the system: Sponsor based or Trial based.
a) Sponsor based approach. This uses the Organisation registration as a sponsor and assigns user roles within the sponsor organisation. This can be used to submit and manage multiple clinical trials.
b) Trial based approach. This is the approach which will be used for trials where the sponsor has not registered an organisation account. For example a non-commercial trial where the sponsor will only run one or two trials and will have a limited number of users. In this case the primary user role will be that of Clinical Trial Administrator.
c) User permissions. There are currently 3 permissions levels for sponsor users: Viewer, Preparer and Submitter. These are Business roles and will be assigned by the Administrators assigned on a Sponsor or Trial level as outlined above.
4) Personas. There is an additional level of guidance in assigning user permissions based on personas, which relate to the job function of the individual. Personas are identified for commercial and non-commercial organisations. Examples of personas are CTIS Submission Manager or Regulatory Project Manager for commercial sponsors, and Study Coordinator or Study Nurse for non-commercial sponsors.
5) CTIS Highlights newsletters. To keep up to date with new training opportunities and information on the implementation you can view the newsletters that have been issued and subscribe to receive future copies of the newsletters.
This is a very brief overview of some of the key concepts in using the CTIS. For more information please visit the EMAs very comprehensive training and support page .