Training
Training is essential to ensuring that best practices are shared across our user communities. ECRIN develops dedicated training and webinars for different stakeholder groups. These range from its CTU network, to principal investigators and sponsors to consortia and affiliated partners in ECRIN supported projects.
The training focuses on ECRIN’s core expertise in the development and coordination of multinational clinical research projects. Through the training, we aim to highlight the existing difficulties and provide the learners with tools to overcome them. Training may also address issues related to data sharing across borders, including the sharing of sensitive data.
ECRIN also partners with other organisations to offer dedicated training to its community. This included a joint training between EMA and ECRIN offered to the ECRIN CTU community, Implementation of the Clinical Trial Regulation (EU) No 536/2014 for academia.
For training that looks at specific aspects of clinical trials, not related to the multinational nature of a trial, we suggest you look to your national network as they have a wide offer of available training.
Format of training
ECRIN hosts in-person and online live training sessions (webinars) on various topics. These trainings are synchronous and held with an expert trainer. They have the advantage of enabling question and answer sessions to quickly address the learners' needs.
We are also in the process of developing our asynchronous training offer. This includes self-paced learning in some topic areas. It has the advantage of allowing the learner to connect to the training at their convenience. These learning modules are flexible and look to address different levels of expertise in a given area.
ECRIN endeavours to make available, where possible, relevant autonomous trainings, to support different stakeholder groups develop competencies on a variety of subjects. Below are groupings of trainings developed or supported by ECRIN within the context of EU-funded projects.
PERMIT Recommendations training
Coordinated by the European Clinical Research Infrastructure Network (ECRIN) and funded by the European Union's Horizon 2020 research and innovation program under Grant Agreement 874825, PERMIT published recommendations on methodological standards to ensure the scientific excellence, validity, robustness and reproducibility of results, and the acceptability of the results generated by personalised medicine programmes.
To better understand the recommendations and facilitate their understanding and implementation, an interactive online training has been developed. This training is designed to address the needs of various stakeholders who contribute to personalised medicine research: researchers from public and private sectors, clinicians, policy makers, regulatory authorities at a national or regional level, students, ethics committee representatives, patient groups, patients and citizens.
The training is available at three different levels of specialization in the domain.
The “PERMIT Overview” series provides a brief overview of the personalised medicine research pipeline. It gives a quick explanation of the methodology that was followed to develop the recommendations, and presents each of the stages of the personalised medicine pipeline, their challenges and how the recommendations can help to strengthen the quality of the research.
The “In-depth” series dives into each of the stages of the personalised medicine research pipeline. For each of the stages the methodology that was followed to develop the recommendations is explained, followed by the gaps and challenges that were identified. The recommendations are then presented in detail and their potential impact is illustrated with examples and use cases. You can choose to delve in depth into one or all of the stages.
The “PERMIT in lay terms” series allows patients and citizens to get familiar with personalised medicine research, its different stages and with the PERMIT project’s recommendations. It presents the “why” behind the PERMIT project, the different stages of the research pipeline, and explains why the recommendations are important and how they can make a difference for patients and citizens.
Register here to follow any or all of the series at your own pace.
The PERMIT project was funded by the European Union Horizon 2020 Research and Innovation Programme under GA N874825. For more information on the project visit the project page
CONSCIOUS II Curriculum and learning materials
The purpose of CONSCIOUS II was to create a curriculum that will train the clinical trialists of the future and provide them with the skills to design, conduct and manage multicentre clinical trials, and report their findings to the highest standard with the internationally agreed CONSORT statement. The e-learning material and curriculum, meet the needs of our target groups - PhD students and early career researchers in the medical, science, pharmacy and health professions.
CONSCIOUS II builds on the work of the CONSCIOUS curriculum, an online platform developed to address this need at the undergraduate level. The CONSCIOUS curriculum enables the generation of undergraduates to develop a fundamental knowledge of clinical trials, to come up with research questions, to read and interpret clinical trial publications, and understand the basic composition of the conduct of a trial. With CONSCIOUS II a more in-depth understanding of the subject is provided to address the training needs of “how to become a clinical trialist”, providing participants with the knowledge and skills to lead their own trial.
This training is available freely for use under a Creative Commons licence CC-BY.
You can access the full curriculum on the dedicated platform (currently under development): http://consciousii.novaims.unl.pt/login/index.php
CONSCIOUS II was funded by the European Union ERASMUS+programme under grant agreement number 2021-1-CZ01-KA220-HED-000023177. ECRIN supported this project as an Associate Partner.
You can also peruse individual lessons below.
Chapter 1 - Clinical Trial Design
Chapter 2 - Trial Methodology
Chapter 3 - Trial Management
Chapter 4 - Quality and Regulatory Affairs
Chapter 5 - Pharmacovigilance and Study Medication
Chapter 6 - Data Management and Statistical Analysis
Chapter 7 - Early Phase Trials
Chapter 8 - Paediatric Clinical Trials
Chapter 9 - Medical Devices
Chapter 10 - Leadership for 21st Century Trialists
Chapter 11 - Open Research and Scientific Publication
Chapter 12 - Training the Trainers of the 21st Century
Chapter 13 - Drug Repurposing
- Overview (not available)
- Teaser Video (not available)
- Full Content
Discover more on the Past training
Through this training attendees learned about the different sections of the Horizon Europe application form.
From September 2023 through to February 2024 ECRIN ran this hybrid training course in conjunction with some of its national partners: CZECRIN, FCRIN, PtCRIN, PCTN, and SlovaCRIN.
An average of 220 participants attended each of the six webinars, which provided a deeper understanding of the processes involved and key considerations for the submission of Horizon Europe proposals. The webinars covered various aspects crucial to the submission process, dedicating each session to the expert-led exploration of specific topics:
-
Introduction session
-
General Overview
-
Regulatory and ethical framework
-
Study Budget
-
Organisation of the Study
-
Data management
To consolidate the online session, parallel onsite sessions were held in ECRIN Member countries (Brno, Czech Republic & Lisbon, Portugal). Additionally, two others sessions were held online (due to withdrawal and lack of prerequisite courses) for those who had initially registered to attend in person in Paris and Warsaw.
Throughout the day, participants had the opportunity to analyse various aspects of the proposal submission process. Use cases were used to highlight elements of the proposal application process for projects in which the host country played a key role. Moreover, participants had the opportunity to talk to some of the people involved in the process. Group work was also included to give participants the opportunity to prepare elements of a proposal for submission.
ECRIN hosted its 3rd CTU Day on 4 December 2023. This online event assembled over 200 personnel from ECRIN's national partner networks' many of whom had not attended the previous iterations.
This year, the event covered an update of ECRIN's tools and services, outlining notably the clinical operations services in which many of the attendees play an integral role. We then focussed on two national partners Ireland (HRB-NCTO) and Norway (NorCRIN) who shared the structure of their national organisation and the links that have been developed with ECRIN. CTU Day is also about keeping our community in the know of what is happening more largely in clinical research and for this we included an update on the Clinical Trials Information System (CTIS) going over the current difficulties, how to overcome some of them, and the very recent changes being implemented as we approach the deadline for the end of the transition in a little over a year. An added feature this year was a focus on data in clinical research. This opened with a presentation on FAIR Data what it is and how one can implement this in practice and then concluded with a very practical case of developing and informed consent form for data sharing.
This interactive event was well received by all who attended and we look forward to the discussions to be had next year.
On December 2nd, ECRIN hosted its second CTU Day, uniting personnel from the CTUs in its national partners across Europe. ECRIN CTU Day looks to consolidate our CTU network, bring together personnel from the ECRIN Member & Observer countries, help them better understand ECRIN’s structure, and share valuable training information to support them in advancing together.
Over 200 participants tuned in to learn about the latest updates at ECRIN and get to know our Czech and German national networks. Moreover, this year we focused on feedback from the first multinational academic submission (TTV-Guide TX) & transition from VHP to CTIS (EU-SolidAct) approved in CTIS. The organization of CTIS, the timing of the various steps, the numerous documents requested, and tips to support others to successfully submit their trials were highlighted by Jette Rahn, Christiane Gaebel and Inge Christoffer Olsen.
On 3 December 2021 EMA and ECRIN offered a joint training session to the ECRIN CTU community, Implementation of the Clinical Trial Regulation (EU) No 536/2014 for academia: Live demonstration of CTIS and Q&A session. Over 275 participants connected during the event and watched demonstrations on CTIS Access & User Management, Completion of an initial application, Modifications to an initial application – under evaluation via RFI (request for information) and Modifications to an authorised initial application via modifications & adding a new MSC.
The training, chaired by Ralf Herold, Scientific Officer in the Regulatory Science and Innovation Task Force – Research and Innovation, EMA and Sabine Klager, Head of Clinical Operations, ECRIN lead to many pertinent questions by the participants.
A few useful links shared in the training include the latest version of the Sponsor Handbook, module 19 ‘CTIS for SMEs and academia’, Module 10 ‘How to create an initial application’, and the subscription link for the EMA newsletter (write to CT.Communication@ema.europa.eu).
The event was a success thanks to the chairs, the informative panellists and the inquisitive participants that kept asking questions up until the close of the training.
On 26 November 2021 ECRIN hosted its first CTU Day bringing together members of its CTU community from all 12 of its national networks. The objectives of the meeting included encouraging staff of ECRIN National Networks affiliated organisations to get to know one another, exchanging information and best practices, discuss training opportunities and synergies.
During this meeting, ECRIN presented its services offer, both clinical operations and supporting projects (capacity development). While national networks shared how they collaborate with ECRIN and how they would like to see things as we move forward. A use case with an ECRIN supported project, FAIRPARK II, was presented by the coordinating European Correspondent (EuCo) and the Project Manager based at the Lead CTU/Sponsor. From this use case attendees were then divided into breakout groups to get to know one another and discuss how to address some of the challenges that arise and identify improvements in the course of a clinical trial.
ECRIN participates in national partner training. In the case of a couple of recent trainings hosted by our French national partner, FCRIN, ECRIN was invited to share its expertise on the coordination of multinational clinical trials. Among the obstacles are the variety of national implementations of the European Regulation on clinical and vaccine trials that govern European clinical research as well as ethical considerations. Focus was also brought to conducting trials with the US and the post-Brexit UK. The early identification of roles and responsibilities of all stakeholders, in both industry and academic research, as a key aspect to ensure good management of the clinical trial and effective harmonization among participating countries, will be covered. In addition, funding sources and key elements of budget preparation when conducting multinational clinical trials will be covered, as well as the role of clinical trial data sharing and GDPR when sharing sensitive data across borders. Primary considerations on how to plan clinical research that include data sharing plans, tools and services were also highlighted.