eCRF
Elektronisk case report form Electronic case report form
Al dataregistrering i APT-KIDNEY foregår via et sikkert webbaseret eCRF med single sign-on, audit trail og automatisk register-linkage hvor tilgængeligt. All data capture in APT-KIDNEY is performed via a secure web-based eCRF with single sign-on, audit trail, and automated register linkage where available.
AdgangAccess
eCRF-adgang tildeles individuelt efter site-aktivering, dokumenteret GCP-træning og signeret delegationslog. Roller (PI, sub-investigator, study coordinator, monitor) styrer hvilke handlinger der er tilgængelige. eCRF access is granted individually after site activation, documented GCP training, and a signed delegation log. Roles (PI, sub-investigator, study coordinator, monitor) determine available actions.
Brugere logger ind via institutionel single sign-on hvor det er muligt; alternativt via personlig brugerkonto med to-faktor godkendelse. Users log in via institutional single sign-on where available; otherwise via a personal account with two-factor authentication.
Log ind på eCRFeCRF login URL aktiveres ved domæneåbningURL activates at domain opening
FunktionalitetFunctionality
eCRF'et omfatter screening- og inklusionslog, baseline- og opfølgningsformular, samtykkeoverførsel, randomisering, AE/SAE-rapportering, og protokoldeviationsregister. Felter med standardiserede svarmuligheder følger SDTM-konventioner hvor muligt. The eCRF includes screening and enrolment logs, baseline and follow-up forms, consent upload, randomisation, AE/SAE reporting, and a protocol-deviation register. Fields with standardised answer sets follow SDTM conventions where possible.
Hvor det er muligt, beriges eCRF-data med oplysninger fra administrative sundhedsregistre. Dette letter den dataindsamlende byrde på centrene, styrker udfaldsvalideringen og giver mulighed for sundhedsøkonomiske analyser uden ekstra dokumentation lokalt. Where feasible, eCRF data are enriched with information from administrative health registers. This reduces the data-collection burden at sites, strengthens outcome ascertainment, and enables health-economic analyses without additional documentation locally.
BrugervejledningerUser guides
Træningsmateriale og supportTraining material and support
Quick start for site-PIQuick start for site PIs
Trin-for-trin gennemgang af aktivering, randomisering, og indberetning af baseline.Step-by-step guide to activation, randomisation, and baseline reporting.
Studiekoordinator-manualStudy coordinator manual
Daglig drift: opfølgningsbesøg, EQ-5D-5L digital udfyldelse, AE-håndtering.Day-to-day operations: follow-up visits, digital EQ-5D-5L completion, AE handling.
SupportSupport
eCRF-supporten varetages af det koordinerende center på Rigshospitalet i samarbejde med GCP-enheden.eCRF support is provided by the coordinating centre at Rigshospitalet in collaboration with the GCP unit.