Werkgroep Lokale Uitvoerbaarheid Activiteiten en planning 2019 – 2020 Kennis delen en verspreiden over: This clinical trial will be conducted at several sites under existing contracts and grants funded by niaid. NIAID will sponsor the Investigational New Drug (IND) application. NIAID contractors, fellows, research networks, clinical research institutes or their auditors are not parties to this Agreement. The nhs and HSC ICPs should be established through a subcontracting agreement with the participating NHS and the HSC organisation supporting the ICP. Appropriate data processing agreements should be concluded using the appropriate agreement template: Primary Care mCTA aims to simplify and thus speed up the process of signing and initiating pharmaceutical and biopharmaceutical clinical trials on patients in primary care. It is expected that the mCTA system for primary care will be used regularly and without modification by all pharmaceutical and biopharmaceutical industry sponsors of clinical research in which NHS patients are admitted to primary care. In such cases, no further legal review is required, saving money and time. The Health Research Authority (HRA) in England and the health services of the requested administrations expect sponsors (and CROs) to use the February 2018 MCTAs unchanged and in accordance with the guidelines when contracting with NHS/HSC organisations to conduct industry-sponsored studies. Similarly, NHS/HSC organisations are expected to accept unchanged MCTAs without further consideration of the elements of the standard model.
Revised in February 2018, the Clinical Trial Agreement (mCTA) and CRO-mCTA (Clinical Research Organisation Model Clinical Trial Agreement) models are designed to be used without modification for industry-sponsored studies of NHS/HSC patients in hospitals in the UK healthcare system. This model clinical trial agreement is concluded in collaboration between the verification of Opleidingsziekenhuizen (STZ), Nefarma, Stichting Het Nederlands Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis (NKI/AvL) and ACRON to facilitate the conduct of clinical trials in the Netherlands. nWMO Working Group Results 2018 – 2019 • nWMO research with positive recommendation no longer belongs to the working group People Tested PIF Information Form Members Esther Beeks (VIG), Lotte Brakel (NFU), Ronella Grootens (NFU), Frank de Haan (STZ), Cecilia Huisman (V&VN Research Professionals), Frits Lekkerkerkerkerker (NVMETC), Veronica van Nederveen (Patientenstem.nu), Eric Roos (DCRF DB), Inge Schalkers (Harteraad), Harrie Storms (VWS), Ellen Terwindt (CCMO, from mid-2019), Joanna Udo de Haes (CCMO, until mid-2019), Roos Verhofstad (Acron) The DCRF 2019 Annual Congress is made possible by: nWMO Working Group Results 2018 – 2019 • The development of the composition of the research dossier when submitting a direct license is not suitable for an agreement on clinical trials. • The CCMO and the President of the MREC established the use of the PIF model as a reference for the evaluation (April 2019) Results of the local feasibility of the working group 2018 – 2019 • Adapted LUH procedure. February 12 meeting Development of national models for scientific research • VIG model – GDPR compliant (but not yet ideal in practice) • Ensure the use of models and synchronization with ECTR in cooperation with the local feasibility working group • ACT article: www.appliedclinicaltrialsonline.com/determining-if-data-electronic-health-record-systems-can-be-trusted- establishment of clinical trials • New clause on the treatment of personal data for all models – Testing of connection start procedures / Support / ECTR Veronica Nederveen, wrn chair PIF working group, September 25, 2019 It`s nice to do with me yesterday, because I know how much time we can save by saying we are doing good. It will not be a legally required bill at this time, but if all parties create a good model and support it, we will make it a little easier. This clinical trial will be conducted at multiple sites under existing NIAID-sponsored contracts and fellowships. NIAID will sponsor the Investigational New Drug (IND) application.. . . .