Centeraktivering Site activation
Sådan tilslutter jeres center sig How your site joins
APT-KIDNEY drives som et nationalt samarbejde mellem nefrologiske afdelinger i Danmark, med planlagt udvidelse til centre i og uden for EU. Aktivering følger en struktureret tjekliste, der sikrer regulatorisk compliance og operationel parathed. APT-KIDNEY operates as a national collaboration between nephrology departments in Denmark, with planned expansion to sites within and beyond the EU. Activation follows a structured checklist ensuring regulatory compliance and operational readiness.
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InteressetilkendegivelseExpression of interest
Den lokale afdelingsledelse eller forskningsansvarlige kontakter sponsor med en kort beskrivelse af afdelingen, kapacitet, og hvilke domæner centeret ønsker at deltage i. Det koordinerende center afholder herefter et indledende online møde.The local department leadership or research lead contacts the sponsor with a short description of the department, capacity, and which domains the site wishes to participate in. The coordinating centre then holds an initial online meeting.
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CentervurderingSite assessment
Domænesponsor vurderer kapacitet, kvalifikationer og faciliteter forud for aktivering. Vurderingen omfatter staffing, GCP-træning, lokal infrastruktur (eCRF-adgang, dialysefaciliteter, blodprøveberedskab) og forventet rekrutteringsvolumen.The domain sponsor assesses capacity, qualifications, and facilities prior to activation. The assessment covers staffing, GCP training, local infrastructure (eCRF access, dialysis facilities, laboratory readiness), and expected recruitment volume.
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Regulatoriske godkendelserRegulatory approvals
Centeret bidrager til de nødvendige godkendelser i overensstemmelse med dansk og europæisk lovgivning: Videnskabsetisk Komité, Datatilsynet, og — for IMP-domæner — Lægemiddelstyrelsen via CTIS under EU CTR 536/2014. Domæner uden lægemiddel-IMP behandles efter den nationale ramme for sundhedsvidenskabelig forskning.The site contributes to the required approvals in accordance with Danish and European regulation: the Research Ethics Committee, the Data Protection Authority, and — for IMP domains — the Danish Medicines Agency via CTIS under EU CTR 536/2014. Non-IMP domains follow the national framework for health research.
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GCP-træning og delegationGCP training and delegation
Alle medlemmer af forsøgsteamet skal dokumentere gyldig GCP-træning. Site-PI udarbejder og signerer en delegationslog, der specificerer hvilke handlinger hver person må udføre.All members of the trial team must document valid GCP training. The site PI prepares and signs a delegation log specifying the actions each individual is authorised to perform.
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CentersamarbejdsaftaleSite collaboration agreement
En skriftlig aftale mellem sponsor og centerinstitutionen specificerer ansvarsfordeling, datadeling, publikationspolitik og finansiering. APT-KIDNEY drives på basis af, at alle deltagende centre bidrager som ligeværdige partnere.A written agreement between the sponsor and the site institution specifies responsibilities, data sharing, publication policy, and funding. APT-KIDNEY operates on the principle that all participating sites contribute as equal partners.
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eCRF og dataadgangeCRF and data access
Personlige brugerkonti til eCRF'et oprettes for hvert delegeret teammedlem. Lokal teknisk integration (single sign-on, dataregisterlinks for danske centre) testes inden site initiation.Personal eCRF accounts are created for each delegated team member. Local technical integration (single sign-on, register linkage for Danish sites) is tested prior to site initiation.
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Site Initiation VisitSite initiation visit
Et formelt site initiation visit (online eller fysisk) afslutter aktiveringsprocessen. Først herefter må centeret begynde inklusion. Datoen for første tilladte inklusion (green light) dokumenteres i ISF.A formal site initiation visit (online or in person) concludes the activation process. The site may first begin recruitment thereafter. The first-permitted-enrolment date (green light) is documented in the ISF.
Næste skridtNext steps
Kontakt sponsor for at indlede aktiveringsprocessen, eller læs mere om governance og protokollerne. Contact the sponsor to begin the activation process, or read more about governance and the protocols.