Collecting research data
EPIC can also be used to help with the identification of subjects who could potentially be eligible for participation in the study. For example, the CTcue search engine in EPIC can be used to search for ‘fields’ (e.g. diagnosis, medication, lab), as well as for free text (e.g. notes, reports, letters).
Additional information on cohort identification is available on the website of the department of Research Data Management. To identify a cohort using CTcue, please contact the Research Data Management helpdesk.
Source data & Case Report Form
The location at which you first record information is the source. Examples could include an ECG printout, hard-copy or digital lab results, questionnaires or a note in the status file or on another document. Source data should be available for all data collected in the CRF (hard copy or database) according to the protocol. These are essential documents that should allow the study to be reconstructed by an outsider. It provides transparency concerning the data that you have used, and it makes the research reproducible, even after many years.
The source data should match the CRF, and any discrepancies should be explained. In some exceptional cases, data may be entered directly into the CRF/eCRF, rather than being recorded in a source document first, but only if it would not be practical and/or feasible to collect such data elsewhere (i.e. no previous written or electronic records are available). Which data are also source data must be clearly documented (e.g. in the protocol, the CRF/eCRF manual or Data Management Plan). The completed and signed CRFs/eCRFs will ultimately be saved as source documentation.
Comparison of source data to the CRF is known as Source Data Verification (SDV), and it is one of the tasks performed during monitoring.
Database (CRF) maintenance
It is important to keep the CRF/eCRF as current as possible. This makes it possible to discover missing or unreadable data promptly, and it may still be possible to retrieve these data. This will benefit the quality of the data. Completion of the CRF/eCRF can also make it possible to identify any study visits that are not arranged well and to adjust them promptly in the protocol. Finally, this can prevent the researcher from facing a large amount of work at the end of the study.
For multi-centre studies, the participating centres should also be reminded to update the CRF/eCRF. The centre performing the study bears ultimate responsibility for the study as a whole, and thus also for the input of data from the participating centres. The use of an eCRF makes it possible to obtain remote insight into how the study is progressing in the participating centre: How many subjects are in the study? How many subjects stopped prematurely? Are the data being kept current? Are all of the data fields being entered? Are all study activities being carried out? Have many AEs/SAEs occurred? If a hard-copy CRF is used, such insight must be obtained by other means (e.g. telephone calls or on-site visits).
ICT services for Researchers
As a researcher you sometimes need more flexibility than the AMC 2.0 network can provide for. In that case you could make use of a specific research network environment and/or cloud services like myDRE or a HPC facility. You can find more information and how to request at the Research - Service Portal.