Focus meeting "Electronic Data Capture"

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Find out how is Electonic Data Capture done for studies (and for registrations) in The Netherlands.


It is not well known how different university medical centres (UMCs) in the Netherlands are dealing with the need to reuse clinical routine data for electronic data capture (EDC) in the context of clinical trials and audits. In this focus meeting we want to first get a better overview (in line with an ECRIN study found [here,]) how UMCs are reusing data from clinical care systems (EHR, PACS, etc.) to fill in EDCs (Castor, Open Clinica, MRDM, Tenalea, MACRO, etc.). If possible we would like to see if standardization and collaboration is possible in the framework of NFU's Data4LifeScience program.

A first pre-meeting analyses seems to indicate the following solutions (overlap possible).

0. "Manual". All reuse is manually done by data managers, physicians etc. Likely to be the most common solution.

1. "Form in EHR": Dedicated forms are built inside the EHR for a specific trial so that data can be captures in a single system with minimal disturbance of the normal workflow. No or limited reuse of data, data is filled in a separate form. Examples:

  • The "Registratie aan de Bron" pilot project is being implemented in this way.
  • (not sure) EVA (VUMC/AMC) is use in this manner albeit with (we think) an bit more reuse from other parts of EPIC.

2. "Internal EDC". A dedicated system is available to create a trial specific EDC form. Data is not reused. Examples:

  • Castor installed in house without reuse

3. "Internal EDC - pre-filled". A dedicated system is available to generate a trial specific data request from the EHR or data warehouse. This query fills in a trial specific form or dashboard in which data can be reviewed and/or corrected. Data is reused. Examples:

  • The MAASTRO/DPI solution for the Dutch Lung Radiotherapy Audit.
  • A pilot at MAASTRO with import to OpenClinica.

4. "Direct to external EDC". From the EHR a message (e.g. FHIR) is generated and send directly to the external system . Reuse of data. Examples:

  • The "DICA" button.
  • Castor has implement this with Radboud Nijmegen.
  • For images CTMM-TraIT offers a direct PACS to TraIT link.
  • XDS.

Solution 2-4 in general require a dedicated connection/message for the actual export of data to a specific trial using the specific syntax which the external EDC system supports (e.g. Castor uses FHIR, Open Clinica - ODM, MRDM - CSV).

Subgoals/Lecture and discussion topics

  • How can we modify EHRs so that they can quickly and efficiently support research.
  • How can we extract data from EHRs and make these data quickly and efficiently available for research (Medical Intelligence)
  • Which EDC systems are commonly being used in The Netherlands?
  • Which connectivity solutions between clinical sources and EDCs are available?
    • Which level are they (see below)?
    • Are there UMCs clearly ahead of others?
  • Are the solution vendor neutral
    • EHR vendor neutral
    • EDC vendor neutral
    • Connectivity vendor neutral
  • Can the solution handle multiple clinical sources (besides EHR the PACS, LIMS, other discipline specific sources, external sources)
    • How are the internal sources interconnected (e.g. warehousing)
    • How is information from external sources processed (e.g. from GP, physiotherapy or radiotherapy institutes outside the UMC)
  • Which standards are being used and why, from different angles
    • Syntactic standards (ODM, CSV, HL7)
    • Semantic standards (e.g. Snomed, ICD, MedDRA, UMLS, NCI Thesaurus, LOINC)
    • Information standards (e.g. ZIBs, ICOHM, umbrella protocols, standard forms)
  • Do current solution scale
    • To other UMCs
    • To big and small trials
  • Is it useful/necessary/possible to standardize and, if yes, which part? Can we formulate a joint Data4LifeSciences vision?


Tweede helft van mei / tweede helft van juni




André Dekker



Principal attendees:

  • UMC employees with hands-on experience in dealing with clinical trial and registration data in routine care.
    • UMCU: Harry Pijl, Rob Cornelisse
    • LUMC: Ineke van Veen, Roger Snijder, Rob Cornelisse
    • TraIT: Marinel Cavelaars, Jeroen Belien
  • UMC researchers and data managers who need data from clinical systems (uit UMCs, Trait, FAIR/DTL Luiz bijv.)
  • EDC vendors
    • Castor: Derk Arts (of meer technische mensen)
    • OpenClinica: Jacob Rousseau (ODM, CSV)
    • MRDM: Pim Koeman (FHIR, CSV eerder)
    • MAASTRO: Tim Lustberg (FHIR)
    • MAASTRO: Fred Körver (XDS)
    • MUMC: Igor Schoonbrood (HL7v3)
    • Tenalea: Jacob vragen
    • Research Manager: Jeroen vragen
    • MACRO -> Pascal koppeling navragen
    • EPDs Furore
  • Connectivity vendors
    • Generic (e.g. Topicus, De Praktijkindex)
    • HL7 FHIR (e.g. Furore)
    • XDS (e.g. Forcare)

Other people/maillists:


13:00 Coffee 
13:15 Welcome and Purpose
13:20 Agenda and Ground Rules
13:25 First talk
13:45 Questions [Quick/special questions answered, difficult/general ones on flipover]
13:50 Second talk
14:10 Questions [Quick/special questions answered, difficult/general ones on flipover]
14:15 Tea break
14:35 Third Talk
14:55 Questions [Quick/special questions answered, difficult/general ones on flipover]
15:00 Fourth Talk
15:20 Questions [Quick/special questions answered, difficult/general ones on flipover]
15:25 Tea break [Meeting chair organizes the flipover questions]
15:45 Discussion [Based on the organized flipover questions]
16:30 Evaluation
16:35 Parking lot
16:40 Breakup
17:00 Out!

See Also