Please note that this document is to be read in conjunction with the latest version of the European guidance and that the national guidance provides some more detailed clarifications and additional topics of interest. This text was written by the FAMHP, the Clinical Trial College and the Belgian association of Research Ethics Committees (BAREC).The information […]Read More "On 30th April, FAMHP published V2 of the Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic"
On 25th March, EMA issued a draft guidance for consultation with deadline for comments on 25th April. https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical_en.pdfRead More "Draft points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials"
On 28th of April, The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published version 3 of their guidance to sponsors on how to manage clinical trials during the COVID-19 (Coronavirus) pandemic. Key changes from v2 (27-03-2020): distributor to trial participant IMP shipment, monitoring, remote source data verification […]Read More "Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic"
Dear Industry Stakeholders, The EMA’s Human Medicines Committee (CHMP) has published a statement urging the EU research community to prioritise large randomised controlled studies because they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of CIVID-19. The statement promotes a harmonised approach to data collection […]Read More "EMA/CHMP statement on Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments"
On the 15th October 2019, the European Commission (EC) published a set of documents applicable to clinical trials that will be authorised under Regulation EU No 536/2014, once it becomes applicable. Please see under the following link EudraLex – Volume 10 – Clinical trials guidelines : https://ec.europa.eu/health/documents/eudralex/vol-10_en#fragment1Read More "Clinical trials guidelines"
A dedicated working group has prepared a new template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational medicinal product on adult patients. The working group consisted of representatives of BAREC (Belgian Association of Research Ethics Committees), pharma.be (the Belgian association of the innovative (bio)pharmaceutical industry) and patient organizations, and was […]Read More "PUBLICATION of ICF templates for interventional trials on adult patients"
The BeCRO board is looking forward to celebrate its 10th anniversary together with ACRON celebrating its 25th anniversary at the EUCROF conference in 2020! ORGANIZERS: EUCROF AFCRO BECRO DATE: FEBRUARY 10, 2020 – FEBRUARY 11, 2020Read More "SAVE THE DATE! JOINED EUCROF, ACRON & BECRO 5TH EUROPEAN CONFERENCE ON CLINICAL RESEARCH"
Webinar: Doing More with Data: Data Anonymization and Pseudonymisation under the GDPR on April 17, 2019 Date & Time: 17 April 2019 from 3:30 PM to 5:00 PM (CET) Attendance Fee: € 90,- for EUCROF non-members € 60,- for EUCROF members using the code DATA0417 Register hereRead More "Webinar: Doing More with Data: Data Anonymization and Pseudonymisation under the GDPR on April 17, 2019"
SAVE THE DATES BLOCKCHAIN IN CLINICAL TRIALS – HYPE OR REALITY ? * June 21, 2019 BLOCKCHAIN IN CLINICAL TRIALS – HYPE OR REALITY? Blockchain in Clinical Trials- How and Why Blockchain and Distributed Ledger Technologies (DLTs) are new disruptive approaches in the Clinical Trials Industry? For the last 2 years, multiple initiatives are moving […]Read More "BLOCKCHAIN IN CLINICAL TRIALS – HYPE OR REALITY?"