Research Roadmap

Cohort identification

EPIC can be used to help identify patients who may be eligible for participation in a study. Visit the website of the department of Research Data Management (RDM) for more information on cohort identification. If you need assistance in identifying a cohort, please contact the RDM helpdesk via RDM Service Portal

Source data & Case Report Form

The location where data is initially recorded is the source. This can include EPIC, ECG printouts, hard-copy or digital lab results, questionnaires, or notes within the patient file or on other documents. Source data should be available for all data collected in the Case Report Form (CRF, whether in hard copy or digital format) as per the research protocol. These documents are essential as they allow the study to be reconstructed by an external reviewer. They provide transparency regarding the data that you used and they make the study reproducible, even years after the study is completed. The EvA Service Centre Research offers a wiki webpage with Epic tipsheets and smart phrases specifically for researchers.

Source data should match the (e)CRF and any discrepancies should be explained. In exceptional cases, data may be entered directly into the (e)CRF, without first being recorded in a source document. However, this is only acceptable if it is unpractical and/or unfeasible to collect the data elsewhere (i.e. no other written or electronic records are available). Any data considered as source data must be clearly documented in relevant study documents, such as the research protocol, (e)CRF manual or Data Management Plan. Ultimately, the completed and signed (e)CRFs will be saved as source documentation.

Source Data Verification involves comparing source data to the (e)CRF, and is one of the tasks performed during monitoring.

Database (CRF) maintenance

Maintaining an up-to-date (e)CRF is essential to identify missing or unclear data promptly. This helps ensure data quality and enables timely resolution of issues (f.e. retrieving missing data). Regular updates can also identify poorly planned study visits, allowing necessary adjustments in the research protocol. Finally, it prevents the accumulation of work for the researcher at the end of the study.

For multi-centre studies, participating centres should be reminded to keep the (e)CRF up-to-date. The leading centre is ultimately responsible for the study as a whole, including the accurate input of data from participating centres. Using an eCRF allows for remote insight into the study's progress in participating centres. Key questions can be tracked, such as: how many participants are enrolled in the study? How many participants stopped prematurely? Are data entries current? Are all data fields entered? Are all study activities performed? Have adverse events occurred? If a hard-copy CRF is used, such insight must be obtained in other ways (e.g. telephone calls or on-site visits).

ICT services for Researchers

Researchers sometimes need more flexibility than the AMC 2.0 network provides. In that case, a specific research network environment and/or cloud services could be used, like myDRE or a HPC facility. Visit the RDM website for more information, or request these services via the RDM Service Portal.