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Clinical Trials Information System (CTIS) reaches major milestone towards go-live and application of the Clinical Trial Regulation

EMA’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022. The Board confirmed that it has verified that the system meets the agreed requirements during an extraordinary […]

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EU regulators expand use of remote source data verification in clinical trials during the COVID-19 pandemic

The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic (V4 04Feb21) expands the use and scope of remote source data verification (rSDV) in clinical trials. Now, in addition to trials involving the treatment or prevention of COVID-19, remote SDV may be considered for […]

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GUIDANCE FOR SPONSORS ON THE USE OF ELECTRONIC INFORMED CONSENT IN INTERVENTIONAL CLINICAL TRIALS IN BELGIUM

On 30 September 2020, the Working group Informed Consent published version 1.0 of the guidance document on the use of e-consent in Belgium. Please find hereby the link to the document: https://overlegorganen.gezondheid.belgie.be/sites/default/files/content/guidance_on_use_of_e-icf_vf.pdf

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On 30th April, FAMHP published V2 of the Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

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 […]

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Draft points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials

On 25th March, EMA issued a draft guidance for consultation with deadline for comments on 25th April.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.pdf

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Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic

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 […]

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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

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 […]

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Clinical trials guidelines

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#fragment1

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