Uitgelicht en gespot op internet (week 37, 2022)

Hierbij weer nieuwe uitgave van het supplement ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet.

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

Association of Clinical Research Organizations (ACRO)

Centrale Commissie Mensgebonden Onderzoek (CCMO)

Clinical trials

Clinical trial results reporting

Committee on Publication Ethics (COPE)

Council for International Organizations of Medical Sciences (CIOMS)

Data sharing, Gegevens, Privacy

Decentralized clinical trials

Diversiteit, Inclusiviteit, Representativiteit

EU Verordening betreffende medische hulpmiddelen (MDR), EU Verordening betreffende medische hulpmiddelen voor in-vitrodiagnostiek (IVDR)

EU Verordening klinische proeven met geneesmiddelen (CTR)

Clinical Trial Experts Group (CTEG)


      • Updates on Q&A
        • a. Patient facing documents
        • b. Transition trials
        • c. Labelling of the IMPs
        • d. Reference to CTD
      • Templates
        • a. Statement GDPR compliance
        • b. Updates Part II template
        • c. Update QP template
      • Interpretation of Art 61 § 5
      • DCT project work
      • Updates on the Delegated Regulation on labelling requirements for unauthorisedinvestigational and unauthorised auxiliary medicinal products for human use
      • ICH-GCP guideline updates
      • Call for a speaker for a workshop on Digital health Technology 8th and 9th November
      • AOB
        • Interplay between CTR (EU) 536/2014 regulation and Regulation (EU) 2017/745 or /746 on (In vitro)medical devices
        • Labelling language
Clinical Trials Coordination Group (CTCG), Heads of Medicines Agencies (HMA)

In order to simplify the re-submission process to CTIS CTCG accepts that the CT numbers within the documents uploaded into the system are shortened concerning the last 2 digits which only show how often the sponsor created previous submissions and re-submitted the applications.

In case of a decision letter the full number including the last 2 digits will be reflected.

If the full number is reflected in the documents and a re-submission takes place, there is no expectation that these numbers are immediately corrected within the documents during the ongoing procedure. This can be done at a later stage when the documentation is updated during a SM procedure.

bron: HMA CTCG Key documents list

The new Clinical Trial Regulation EU No. 536/2014 and Implementing regulation (IR) which came into force on 31 Jan 2022introduced the concept of safety cooperation and work-sharing among Member States (MSs)

Joint Action (JA) 12 of the EU4Health Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials or SAFE CT supports these new concepts through provision of additional resources and expertise necessary to implement the new regulation.

The goal of this JA is to establish and maintain cooperation in safety data assessment in clinical trials via building capacities and performing training activities in the participating MSs. The experience gained during the JA will be used to update and improve the procedures on cooperation and training in safety surveillance in clinical trials.

The project is currently in grant agreement preparation phase and will run for 36 months (with a retrospective start date from 01/05/2022 – 01/04/2025).


Clinical Trials Information System (CTIS): Protection of personal data and commercially confidential information

Etiketteringsvoorschriften voor niet-toegelaten geneesmiddelen en auxiliaire geneesmiddelen

European Federation of Pharmaceutical Industries and Associations (EFPIA)

European Medicines Agency (EMA)

International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)


Nederlandse Vereniging van Medisch-Ethische Toetsingscommissies (NVMETC)

Society for Clinical Data Management (SCDM)

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


Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties

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