Le 28 prochain se déroulera notre colloque sur les données de santé en vie réelle.
Au programme de cet évènement deux tables rondes :
L’entrée en application du nouveau Règlement européen des dispositifs médicaux le 26 mai prochain va modifier la marche à suivre en termes de matériovigilance lors d’une investigation clinique. Deux experts de l’AFCROs nous détaille ces évolutions.
Le point avec Nadia Zenasli et Christophe Grenot membres du groupe de travail Dispositif Médical de l’AFCROs.
Retrouvez également tous les articles précédents publiés dans DeviceMed en cliquant ici
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”.
To enable mutual agreement on the rules of applying the GDPR requirements to clinical research and help CROs demonstrate compliance with the GDPR, the EUCROF task force initiated, developed and now is proud to introduce the first Code of Conduct in the industry.
The Code is aimed to explain the application of the GDPR to the services delivered by the CROs.
If you are a data protection officer, you work in a regulatory or legal department, if you are a healthcare professional wishing to boost your awareness about protection of personal data in the trial-related domain and get some insightful tips, you are welcomed to join us on this webinar!
25 May 2021, on the day of the 3rd anniversary of the GDPR, we will guide you through the first clinical trial Code of Conduct. You will have the opportunity to ask questions about the Code and our reasons to trust in its value, as well as receive practical advice on adherence.
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.
In drug development the most sensitive part is the switch from non-clinical to clinical conduct, namely the First-in-Human/First-in-Patient (FIH/FIP) Phase I clinical trials.
To ensure utmost safety a trial specific risk analysis and risk-minimizing measures are required for trial design and protocol as well as for the translation into practical conduct for executing infrastructures in specialized Phase I research clinics.
The basic principles of safety arrangements in clinical trials are regulated by international guidelines and local laws and requirements. For the EU countries the Clinical Trials Regulation 536/2014 based on ICH GCP E6 is implemented as binding law for the conduct of clinical trials.
Since this law does not distinguish between the different phases of drug development starting with FIH/FIP Phase I up to confirmatory Phase III trials, the EMA took action in 2017 to update the guideline for FIH/FIP clinical trials which states that “the early clinical development of human medicinal products has an intrinsic element of uncertainty in relation to both the possible benefits and risks of a novel drug candidate”.
This webinar will help to understand more about the risks and benefits of early-stage clinical trials conducted in specialized Phase I research clinics. It will highlight the points to be considered for planning and conduct of Phase I trials:
Le SNDS constitue une base de données médico-administratives nationale détaillée sur le parcours de soins des patients et leur consommation de produits de santé. Même s’il présente certaines limites, il est de plus en plus utilisé à des fins de recherche, notamment dans le domaine du DM.
Le point avec Sandrine Colas membres du groupe de travail Dispositif Médical de l’AFCROs.
Retrouvez également tous les articles précédents publiés dans DeviceMed en cliquant ici
Jeudi 8 avril se tenait la table ronde Recherche Clinique en temps de crise sanitaire animée par le Dr Denis Comet.
Retrouvez l’intégralité des échanges dans cette vidéo.
Après 3 ans de travaux, la Fédération Européenne des CROs (EUCROF) a déposé le 17 mars dernier, son projet de Code de Conduite RGPD auprès de la CNIL, engageant le processus d’approbation par l’ensemble des autorités de protection des données des états membres de l’Union Européenne.
The EUCROF and eClinical Forum Electronic Informed Consent (eConsent) Joint Task Force are pleased to announce the publication of the eConsent Implementation Guide (version 1). The joint task force was formed in 2019 with a view to look at some of the barriers to adoption of eConsent considering the benefits to stakeholders. eConsent offers remote electronic options for informing and consenting trial participants of a clinical trial, this being a particularly useful capability especially during the pandemic period when site visits are reduced.
The eConsent Implementation Guide provides an overview and practical considerations when implementing eConsent within a clinical trial.
The eConsent Implementation Guide includes:
We’d like to thank EUCROF and eClinical Forum contributors for their invaluable support in the development of this document.
For more information please contact econsent@eucrof.eu.