…not anymore about whether it is possible, but about how soon it will be achieved.
The GDPR (General Data Protection Regulation) has been with us for three years now. Yet, the industry continues to struggle through the multiple legal interpretations of how the GDPR requirements apply to the clinical research.
Ethics committees, data protection officers of the clinical sites and of study funding sponsors, as well as the other stakeholders, defend their approaches. This altogether expands the gap in how a CRO and therefore, a Sponsor should process personal data to state with confidence, “We are GDPR compliant”.
Welcome to e-LearnIN, the EUCROF e-learning platform
EUCROF - the European CRO Federation - is pleased to present its innovative e-learning platform, where you can find all the educational materials delivered in the webinars organised by the EUCROF Events and Training (E&T) Working Group.
Developing training and educational programmes for clinical research is one of the main aims of the Federation, which implemented this e-learning platform to foster the exchange of educational materials and to assist its members with educational programmes. A webinar is a very effective tool to reach these goals, therefore EUCROF systematically delivers webinars focused on specific areas of interest for its members.
e-LearnIN, EUCROF’s e-learning platform has been designed to provide webinar participants with a virtual space to remain in contact with the teacher/speaker after the webinar’s end and help them retrieve media and documents proposed as supportive materials. This will allow participants to improve their experience and fulfil more easily the purpose of the webinars.
For each EUCROF webinar you can find on this platform the educational materials presented during the webinar (pdf of the presentation), the short bio of the speaker, the recorded video of the webinar and any possible additional materials (publications, papers, exercises, etc.).
Moreover, at the end of each webinar, a forum discussion will be opened i.e. a virtual room that will be accessible through the EUCROF e-learning platform at the end of the webinar and will allow the participants to ask further questions to the speaker or start an open discussion on the topic of the webinar.
Here you can have a look at the list of the future and past EUCROF Webinars.
About the EUCROF Association
EUCROF Association was founded in October 2005, with the aim to promote high quality clinical research in Europe as well as to represent the interests of CROs in interactions with authorities, regulatory bodies, companies, researchers, experts and patients. Favouring a close relationship between CROs and Stakeholders is one of the main scopes of EUCROF, that is always proactive in facilitating the exchange of information within the clinical research community.
The Federation consists of Members/Associate Members from 25 EU countries. It stands for over 300 member CROs and over 20,000 employees.
Since December 2006, the Federation is managed by an Executive Board which holds monthly meetings. Also, the Full Members Board meetings are held monthly. Each year, the Federation organises two face to face General Meetings (in Spring and Winter) with all its Members.
EUCROF developed the creation of 12 Working Groups, which represent an open area of discussion on specific areas of interest for Members.
Do you want to know more about EUCROF Working Groups and their initiatives? Please click here.
EUCROF Events and Training Working Group
The EUCROF Events and Training (E&T) Working Group (WG) aims at delivering activities to build relationships across organisational boundaries as well as at giving members (and sometimes non-members) the opportunity to develop skills, expertise and grow within their respective role. The WG is proactive in identifying, supporting and promoting good practices in education in clinical research and delivering accredited training activities.
It also provides a forum for discussion of key issues impacting clinical research and opportunities for learning and allows to enhance professional competence as well as a wider confidence and understanding of clinical research. The members of this WG are engaged in activities aimed at promoting and sharing expertise and developments, determining and setting overall strategic direction for CROs related education and training matters, and liaising with other relevant organisations, to ensure that the work of the group is up to date.
For more information, please have a look at E&T WG leaflet.
Should you have any questions about registration, do not hesitate and contact us by email firstname.lastname@example.org.
…not anymore about whether it is possible, but about how soon it will be achieved.
In the light of a global pandemic, clinical research in early-stage development reached a new degree of interest as the world relies on scientists to find solutions for unmet medical needs. Under the pressure of this scenario all parties involved in clinical research have to re-organise the working floor and find to ensure the utmost safety of trial participants while in parallel improve the productivity and speed.
As of January 2022, only 9 months from now, all scientific research with medicinal products in the EU need to be submitted via the Clinical Trial Information System, the CTIS. To make sure all future users of the CTIS system, both sponsors and member states, are familiar with the settings and way-of-working in the system, the EMA has setup a training program.
The Council of the European Union, on 7th December 2015, granted pan-community policy recognition for “personalized medicine for patients”, placing the theme among the EU priorities for the next decades and inviting the Member States and the European Commission to engage in reaching its full potential.
This webinar on electronic informed consent (eConsent) addresses the practical considerations when implementing eConsent. It introduces the EUCROF Implementation Practical Guide to eConsent which addresses key themes and hot topics, and provides a view on the modernization of the clinical trials informed consenting process, including the current perception shift of eConsent adoption in light of the COVID-19 pandemic.
Software is used widely in clinical trials: from managing worldwide
trials to finding and scheduling patients, gathering trial data, and
analyzing trial results.
The patient centric benefits of electronic informed consenting (eConsent) technologies have been well documented, from the provision of better educational mechanisms of informing patients and overall improved comprehension of the study. There is variability in permissible laws around the European region and globally to be aware of.
Hospitals are over-burdened and people have to stay home as much as possible. How are we dealing with study visits and other aspects of the trials? This webinar sheds light on a risk-based approach to ongoing trials and the international guidance that has been released, to protect trial subjects as much as possible and limit the damage to ongoing trials as much as possible. The webinar highlights the situation for the sites as well as for the sponsor/CROs, goes into dealing with quality control, and looks to find opportunities that may come from this difficult time.
Since June 2019, a new EU Guideline on paper and electronic Trial Master File (TMF) is in effect. The Guideline offers clarifications in many aspects. For example, the requirements on electronic TMFs (eTMFs) are clearly stipulated and the essential documents listed in ICH-GCP are supplemented by additional important documents. Emphasis is given to the interface between sponsors and CROs by providing many elements that should be present in either contractual agreements or other documents that describe the cooperation between the parties.
The Patient Centricity Effect – How it benefits Patients, Sites and Sponsors – Practical cases from paediatric studies
Patient centricity has become something of a buzz phrase over the last few years. However, behind the name lies a concept that offers real value. During this webinar, these benefits will be discussed, highlighting:
1. Results from recent research that quantifies the positive business impact to sponsors by taking a patient centric approach
2. Exploration of real examples where the patient has benefited from being put at the heart of clinical research
3. Advantages experienced by sites when patients are central to study planning and implementation
This informative session will arm you with data and examples to take to your own organization to support the build and growth of patient centric practices. In addition, a collaborative discussion about the future of patient centricity and its effect on the industry will complete the webinar.
Moreover, the webinar will provide practical examples on how to involve children in clinical trials.
The EUCROF Paediatric Working Group is pleased to present the first Training on
Essentials of Paediatric Clinical Research
What you need to know when preparing, conducting and monitoring paediatric clinical trials.
Nowadays, the collection, analysis and processing of data originated from a clinical study or for marketing settings is supported by specialized applications. Therefore, validation of computerized systems has become a central aspect in CRO’s daily work.
This webinar aims to give a general overview of validation procedures focusing on validation processes of non-configured (GAMP category 3) and configured (GAMP category 4) products. To illustrate this, we will play through the validation steps with the help of an example. Furthermore, we will present relevant guidelines and typical roles and responsibilities in validation and we will look at what we have learned so far from audits and inspections.
A year ago, the GDPR came into effect. We were told about consent. We knew the consent. The two concepts seemed identical. It would be quite simple to reconcile the GDPR with the CTR.
Then we thought about implementing the GDPR and thought about its concepts. We therefore had to answer the first question in the implementation of the GDPR for clinical trials: what is the legal basis for the processing of personal data? And there, surprise… it was not that clear at all.
This session will provide detailed information on how to interpret GDPR according to CTR and other publications. We will finally cover the future of GDPR implementation for CROs with a Code of Conduct. Indeed, authorities encourage the setting up of code of conducts which would help ensuring interpretation and compliance with regulations in various data processing sectors.
With the increasing complexity of the clinical trials, a need has surfaced for emphasising critical vs less important aspects of clinical trial management. Analysis for the efficacy of the traditional approach to monitoring of clinical trials demonstrated an unfavourable ratio between efforts and effect. ICH GCP E6 R2 defines innovative approaches, which include Quality Risk Management, Quality-By-Design, prioritised resourcing and risk-based monitoring. This webinar will focus on risk-based monitoring as a principal measure for improving the quality and effect of the outcome of the clinical trials monitoring, whilst respecting resourcing needs. Other main topics will include remote and centralized monitoring and their role in the risk-based approach.
In literature there are more and more publications raising concerns about the interpretation and misuse of the p-values, in some cases to support decision-making. This is known as the “reproducibility crisis” and it is a primary concern for the biomedical research and pharmaceutical industry.
The purpose of the webinar is to explain the very meaning of the “reproducibility crisis” and the concerns surrounding the p-value and the hypothesis testing as expressed in the recent articles published by Nature and American Statistician, among other journals.
Many organisations are trying to exploit more value from their data to improve their products and services, offer new ones and optimise their own internal operations. With the General Data Protection Regulation (GDPR) in place, these organisations need to determine the lawful basis for such activities. De-identification techniques, such as pseudonymisation and anonymisation, can play an important role in facilitating such secondary uses and disclosures of data. In regard to de-identification, the GDPR introduces nuances that have not previously been seen, recognising the existence of different levels of de-identification and explicitly adding references to pseudonymisation as an intermediate form of de-identification. This webinar will describe pseudonymisation and anonymisation techniques, specifically for clinical trial data, and how these fit within the GDPR regulatory framework.