Uitgelicht en gespot op internet (week 30 – 36, 2022)

Na een afwezigheid van zes weken ontvangt u hierbij weer een nieuwe uitgave van het supplement ‘Uitgelicht en gespot op internet‘. Zoals gebruikelijk ook in deze uitgave een overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet.

Tevens breng ik onder de aandacht de DCRF Survey Clinical Trials Regulation (CTR). Klik hier om direct naar de survey CTR te gaan.

Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.

Accelerating Clinical Trials in the EU (ACT EU)

The workplan lays out deliverables and timelines. In 2023, they include:

  • Large, multinational clinical trials: establishing a support process specifically aimed at academic sponsors in order to make the EU a more attractive region to conduct clinical research
  • Implementation of the CTR: a particular focus on Clinical Trial Information System (CTIS) and CTR training activities and trouble-shooting any issues encountered by clinical trial sponsors
  • Multi-stakeholder platform: will be established in 2023 to facilitate the evolution of the clinical trials environment through regular dialogue between all stakeholders, including patients, healthcare professionals and academia, to find practical solutions to enable and drive change
  • Modernisation of good clinical practice: ACT EU will support not only the adoption but also the implementation of revised EU guidelines in technology and clinical trial design
  • Facilitation of innovative clinical trial methods: the initiative will issue guidance on decentralised clinical trials by the end of 2022 and publish a methodology roadmap to identify and prioritise key advances in clinical trial methods.

bron: EMA news ‘ACT EU multi-annual workplan 2022-2026’ d.d. 30 augustus 2022.

EU Decentralised Clinical Trials (EU DCT) project

Since March 2022, the Clinical Trials Coordination Group (CTCG) is responsible for the project management of the EU Decentralised Clinical Trials (EU DCT) project. The EU DCT project is part of the priority actions conducted in the context of the Accelerating Clinical Trials in the EU (ACT EU), which started at the same time as the launch of the Clinical Trials Information System (CTIS) and the implementation of the Clinical Trials Regulation (EU) No 536/2014 (CTR). The DCT project represents a broad collaboration across the European Medicines Regulatory Network with a cross-disciplinary project group including amongst others clinical trial authorisation experts, ethical experts and Good Clinical Practice (GCP) inspectors across Member States. It aims to provide a harmonised and transparent approach for the use of DCT elements in clinical trials. To this end, a Recommendation paper on the use of DCT elements in clinical trials is planned to be published by the end of 2022.

bron: HMA, Clinical Trials Coordination Group

Advarra (Verenigde Staten)

Algemene verordening gegevensbescherming (AVG), Uitvoeringswet Algemene verordening gegevensbescherming (UAVG), WGBO, Data access, Data control, Privacy

Centrale Commissie Mensgebonden Onderzoek (CCMO)

Clinical trials

Clinical Trials Coordination Group (CTCG), Heads of Medicines Agencies (HMA)

Clinical Trials Directive (CTD), EudraCT, Transitional  trials, CTR, CTIS

Clinical Trials Regulation (CTR)

Clinical trial results reporting

Commissie Genetische Modificatie (COGEM)

Council for International Organizations of Medical Sciences (CIOMS)

Decentralized Clinical Trials

Diversiteit, Inclusiviteit, Representativiteit

Drug development

Dutch Association of Research Quality Assurance (DARQA)

Dutch Clinical Research Foundation (DCRF)

Dutch Oncology Research Platform (DORP)

Ethics review

European Clinical Research Infrastructrure Network (ECRIN)

 European CRO Federation (EUCROF)

European Federation of Pharmaceutical Industries and Associations (EFPIA)

European Medicines Agency (EMA)

Examenbureau Medisch-Wetenschappelijk Onderzoeker (EMWO)

Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Pharmacovigilance Practices (GCP),

Good Publication Practice (GPP)

Good Automated Manufacturing Practice (GAMP), International Society for Pharmaceutical Engineering (ISPE)

Informed consent

Medical Device Coordination Group (MDCG)

Methodologie, Statistiek

Nieuwsbrief voor Goede Onderzoekspraktijken

Nederlandse Voedsel- en Warenautoriteit (NVWA)

Public health research

Rathenau Instituut

Real World Data (RWD)

Reporting guidelines

Research integrity

Trial Master File (TMF), Investigator Site File (ISF), electronic Master File (eTMF), electronic Investigator Site File (eISF)

U.S. Food and Drug Administration (FDA), Verenigde Staten



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