Data collection tools

There are several standard tools for data collection for prospective and retrospective studies, as well as studies that are or are not subject to the WMO. This applies both to data collection on study participants by researchers and self-reported data submitted by study participants via web surveys. There is also a tool for monitoring study progress and an online randomization tool.

Available tools

Castor EDC is a suitable platform for building study databases for studies that are subject to the WMO, but it is also excellent for non-WMO studies. Castor also includes a randomization module for setting up randomization schemes based on block randomization.

If you build your eCRF pages/study database in Castor EDC, you can have study participants complete surveys online and view the results from your own Castor account. The survey module in Castor EDC lets you send out surveys to a predefined group of respondents, according to a fixed schedule, making it a suitable tool for most studies.

LimeSurvey can be used to build a more advanced survey.

Researchers can design their own Castor and LimeSurvey questionnaires, but can also outsource this for a fee. The costs will be billed to the project, and RDM will always create a quote first. You can also purchase a fixed number of support hours for assistance during the design process and for a final database review.

LDOT is a tool for managing the personal information of study participants and monitoring study progress.

Testing a study database

If your study is subject to the WMO, remember that the study will have to be tested by an independent reviewer, in addition to the user acceptance test that the study team itself has to perform (and document). More information about the main data collection tools can be found on the corresponding pages.

The RDM helpdesk can help you select one of these standard tools and suggest alternative solutions, as well as designing and building interactions with other systems.

Requirements for data collection tools

It is not allowed to enter data straight into programs like Excel and SPSS during the data collection process! These programs do not meet the requirements for research involving human subjects, e.g. because they lack validation features, audit trails and a system for managing roles and permissions.

If a data collection tool is hosted by Amsterdam UMC or an Amsterdam UMC partner (e.g. SURF, Lygature) then the appropriate licenses and Processor Agreements are in place. If you wish to use another data collection tool, you must discuss this with the Data Protection Officer first (e.g. for DPIA, BIV classification and a Data Processing Agreement). Please contact the helpdesk to verify whether an institution or company is an Amsterdam UMC partner.

Castor EDC

Castor EDC (Electronic Data Capture) is an easy-to-use web-based tool for building electronic Case Report Forms (eCRFs). Castor EDC is ICH-GCP and ISO 27001 certified. So this platform helps meeting the requirements for electronic data collection in studies subject to the WMO. Make sure that your study database complies with ICH-GCP and the GDPR by enabling the correct settings <Link follows>. It is also important to request medication data and (S)AEs correctly (you can find example forms on the Castor Form Exchange).

Castor EDC is also a valuable tool for data collection in studies that are not subject to the WMO. In addition to serving as an eCRF system or a platform for data entry of paper CRFs, Castor EDC also allows you to send web surveys (for complex surveys, you can also use LimeSurvey) and randomize study participants. Castor EDC can also be linked to Ldot. Ldot is a third-party tool for workflow management, in other words the logistics within a clinical study, see also LDOT.

RDM can support research project groups in transforming data received from the RDP into a format that can be uploaded to Castor. Phyton knowledge is highly recommended to do the scripting. After transformation to the correct format, the CastorDataBridge tool can be used to perform the import. The power of the CastorDataBridge tool is the validation of the imported data. If an error occurs during the upload process, a clear message will be displayed.

For advice, please contact the RDM Helpdesk.

Training course

Castor EDC is a user-friendly tool and most users only need to follow a few brief tutorials or a quick training course before they are able to design their own database. For more information about training courses and support, see the internal tutorials of the Castor Academy.

ICH E6 (R2) GCP / FDA 21 CFR Part 11 compliant platform
GCP features:
- All actions are recorded in an audit trail
- Locking and unlocking features
- Digital signing of CRFs

Track reasons for changes (enable GCP option ‘Confirm Changes’)
ISO 27001 certified: complies with requirements on access and back-ups
- Prevents unauthorized access to data
- Data are backed up regularly, and back-ups are maintained
- Assign different user roles with corresponding permissions

Suitable for multi-center studies
Various validation options (min-max values, integrated calculations, etc.)
Source Data Verification capabilities (e.g. placing queries and confirming correct entries)
Encryption of privacy-sensitive information
Supports stratified block randomization with various alternating block sizes (for complex randomizations, please consult the statistics helpdesk)
Research data deblinding
Library of existing CRF pages, including forms approved by Amsterdam UMC
Web survey capabilities
Data import capabilities from Excel
Data can be easily exported from Castor to e.g. CSV, Excel, SPSS

Check the Castor website for more information.

Amsterdam UMC has a license to use Castor EDC for non-commercial studies in which Amsterdam UMC is the coordinating center. You can request an account to build your own study in Castor EDC via: data castor EDC register. Please use your Amsterdam UMC email address. A Castor EDC Quick Start can be found here. There are also free online tutorials on building your own study: academy castor EDC. Training sessions for advanced users in collaboration with Castor EDC are organized.

Please note. To use Castor EDC at the institutional rate, you have to enter the sponsor’s billing code when your study goes live. For the billing code, contact the RDM Helpdesk

Online surveys: LimeSurvey

For more advanced survey types or invitation methods, LimeSurvey can be used.This tool lets participants complete surveys online, if necessary anonymous. If the entered data are not subsequently changed by the researcher (demonstrably and documented), this program may also be used in studies subject to the WMO by way of exception.

PROMIS for measuring patient-reported outcomes

The Patient-Reported Outcomes Measurement Information System (PROMIS) is a collection of high quality generic patient-reported outcome measures (PROMs) for measuring commonly relevant symptoms and functions, such as pain, fatigue, anxiety, depression, sleep disturbances, physical function, and the ability to participate in social roles and activities. PROMIS can be used across health conditions and is increasingly used internationally and recommended by the Dutch program Outcome-Based HealthcareCommonly used PROMIS short forms have been built into Castor and LimeSurvey. Contact the Dutch-Flemish PROMIS National Center for more information about PROMIS. Contact the PROM Expertisecentrum or measurement experts from the department of Epidemiology and Data Science for more help with selecting relevant PROMs for your research.

PROMIS users need to register at the Dutch-Flemish PROMIS National Center. After registration RDM will provide the xml-file (in case it concerns Castor) or lsg-file (in case it concerns LimeSurvey) to be imported in your Castor eCRF or LimeSurvey questionnaire. A data dictionary is provided as well.

For more general advice on tools, please contact RDM.

Interviews

Recording audio

Safely recording and processing audio for scientific research

Several tools for safely recording and processing of confidential audio for scientific research have recently been made available to Amsterdam UMC researchers, consisting of connected recording tools (dictaphone or app) and special software for processing the (encrypted) audio files.

For more information and to request the various instruments, see the service description in the Service Catalogue of ServiceNow: Calls and requests - Service Portal (service-now.com)

LDOT: guiding and monitoring study progress

You can use the web-based program LDOT to manage the personal information of study participants and monitor study progress, e.g. to determine which study participants should be approached for a (follow-up) measurement. LDOT is not used to capture study data, but only tracks contact and process data, such as the dates on which a certain event took place and what follow-up actions were linked to it. LDOT can communicate with data collection tools such as Castor EDC, so that relevant data do not need to be entered twice.

Research Support