Data collection tools
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 RDM helpdesk to verify whether an institution or company is an Amsterdam UMC partner.
Available data collection tools
- Castor EDC (eCRF/randomization & online questionnaires)
- LimeSurvey (Online questionnaires)
- LDOT (guiding and monitoring study progress)
- PROMIS (Patient-Reported Outcomes Measurement Information System)
- Philips Voicerecorder & SpeechExec (Voice Recording & transcription)
- Amberscript (transcription)
Castor EDC is a suitable platform for building study databases for studies that are subject to the WMO, but it is also ideal for non-WMO studies. Castor includes a randomization module for setting up a (stratified) randomization procedure based on (random or fixed) block randomization.
The survey module in Castor EDC lets you send out surveys to a (predefined) group of respondents, anonymous or not anonymous according to a fixed schedule, making it a suitable tool for most studies.
Training courses
Castor EDC is a user-friendly tool. Users need to follow a few online tutorials to be able to design their own database/survey. You can follow Castor-basic tutorials for free online at Castor Academy. An advanced training course is also available. Sign up by sending an email to RDMtrainingen@amsterdamumc.nl
Key features of Castor EDC
- 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.
Request an account
Amsterdam UMC has a license to use Castor EDC for non-commercial studies in which Amsterdam UMC is the coordinating center. Information how to create an account to build your study in Castor can be found in the Castor EDC Quick Start
Billing code
To use Castor EDC at the institutional rate, you have to enter the sponsor’s billing code when your study goes live. You can find information on the billing code in theCastor EDC Quick Start.
Support from RDM
RDM provides advice on the application, required documentation and use of Castor. RDM can also review a study built in Castor free of charge before it goes live. We can also build studies in Castor EDC for you for a fee, for which a quote will be prepared following an intake session. For support, contact RDM.
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.
Key features of LimeSurvey
- Extensive formatting options
- Wide range of question types, including ranking
- Complex routing options
- Various validation options
- Multilingual surveys
Request an account
Amsterdam UMC has a license for LimeSurvey. Questionnaires in LimeSurvey can be set up by the RDM LimeSurvey experts or by the investigator.
For requests or for more information, please contact the RDM helpdesk.
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.
Requests for use
For questions about LDOT, please contact MEMIC at Maastricht University directly. They can also set up the LDOT database for you. This does incur costs. Annual license fees are also charged.
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 Healthcare . Commonly 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.
(Confidential) audio recordings for scientific research can be made securely via the Philips Dictaphone or via the Philips Voice Recorder app that can be installed on a mobile phone. To access, play and assist in transcribing the encrypted audio recordings, the Philips SpeechExec Transcribe software is available.
For more information and to request the various tools, see the service description in the Service Portal: Voice recording & transcripts.
Amberscript is a tool to transcribe automatically your audio and video recordings from speech to text.
For more information and to request an Amberscript account with sufficient transcription hours , see the service description in the Service Portal: Voice recording & transcripts