- EPiMAP Study Data is collected first on paper CRF: “Recruiting centres” should use the paper format of CRF and save hard copy
- Afterwards, data is transcribed from paper CRF to electronic CRF by local staff within 2 months maximum after end of patient follow up
- Electronic CRF is built by ESA using OpenClinica software
- Password are sent/reset from ESA Secretariat (Password confidentiality: 1 user = 1 password)!
- Up to 3 users per hospital (1 Investigator + 2 Data entry profiles)
- This test-site is completely similar to the real instance.
- There are 2 different test-users with log-in information available in the eCRF Guidance
For any questions on eCRF access, problem regarding password or for any technical issue, please contact your ESA OpenClinica Administrator for help at email@example.com mentioning your user name and your EPiMAP Centre number.
Data Collection and data entry
Please make sure you follow closely the Protocol provisions on data handling and record keeping (p23, section 10. Paper CRF).
- Paper CRF should be anonymised and handled confidentially.
- Patients are anonymised and identified through a 9-digit code: xxx-xxx-xxx 3 digit code for the country, 3 digit code for the hospital (no letter) and 3 digit individual patient number, separated with hyphens.
- Local investigators will then transcribe all collected data from paper CRF onto the eCRF
- The CRF Coversheet and Confidential Patient log sheet must be used to match CRFs with your medical records.