Elektronisk case report form Electronic case report form

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.

For danske centre suppleres eCRF-data med automatisk linkage til Sundhedsdatastyrelsens registre (Landspatientregistret, Lægemiddelstatistikregistret, m.fl.) for udfaldsverifikation, mortalitet og health economics-variable. For Danish sites, eCRF data are supplemented by automated linkage to the Danish Health Data Authority registers (the National Patient Register, the Register of Pharmaceutical Sales, et al.) for outcome verification, mortality, and health-economics variables.