Data Entry and Management Procedures for Clinical Trials
Detailed instructions on how to enter and manage data for clinical trials are provided in this content. It covers steps such as screening, randomization, data entry, use of electronic case report forms, and various forms to be completed throughout the trial period. The process involves both unblinded and blinded trial personnel, with specific forms for trial medications, consent, withdrawal, and follow-ups. Users attempting unauthorized data entry will be redirected with a warning message displayed.
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Presentation Transcript
Screen, Screen, randomise randomise and enter data and enter data To screen, randomise or enter data, go to www.cric.nu/covid-steroid-2 and click on the Screen, randomise and enter data icon
Data Data entry entry For detailed information on how to use the electronic case report form (OpenClinica), go to http://www.cric.nu/covid-steroid-2-ecrf/
Data Data entry entry Data entry performed by both unblinded and blinded primary trial personnel Screening form Baseline form Administered trial medication form (day 1-7) Consent form Withdrawal form Data entry performed by blinded primary trial personnel Dayforms (day 1-14) Discharge and readmission form Follow-up forms at day 28, 90 and 180
Data Data entry entry If a user tries to enter data in a form that he/she do not have access to, the user will be directed back to the front page and a warning message will appear in the upper left corner of the screen:
