CTIMP studies
The College mandates that the electronic data software managed by the Clinical Data Systems team is used for all RGIT sponsored CTIMP studies. Further guidance is available on the 51³Ô¹ÏÍø Clinical Trials Unit page: Clinical Data Systems.
non-CTIMP studies - REDCap
What is REDCap?
Research Electronic Data Capture (REDCap) is a popular data collection tool with a simple web-based interface designed for clinical researchers to manage their study data collection needs. It is used internationally for academic research and by some Research groups within 51³Ô¹ÏÍø College. .
What does the College Offer?
51³Ô¹ÏÍø is registered as a with the REDCap consortium. Under the terms of this licence, a central instance of the software has been installed on ICT run College infrastructure which can support multiple concurrent projects.
The software is provided for the purposes of non-commercial research only. The research activity must be led by an 51³Ô¹ÏÍø College CI.
The software installation is not validated to Good Clinical Practice (GCP) standards and is not suitable for CTIMP (drug) studies or studies requiring MHRA regulatory compliance.
College is providing a secure hosting environment for the REDCap software. Training and data collection form design services are not offered and so it will be the responsibility of the research group to design and build the eCRF forms appropriately. Redcap is not advised for RCT blinded studies, as it does not have a randomisation function that fully supports unblinded studies.
How do I request Access?
Research groups wishing to use REDCap should start by reviewing the service vision and service definition below to ensure that roles and responsibilities are understood. Once happy with the service definition, .
The request will first be reviewed by the RGIT and Faculty of Medicine GDPR teams to ensure that ethical and data protection approvals have been discussed and then a REDCap project workspace will be provisioned.
The service definition can be found here: 51³Ô¹ÏÍø College RedCap Service Definition (Word). Principle Investigators and Research teams should ensure that they read and understood the responsibilities, especially around the knowledge required for use and responsibility for data quality.
The data management guidance can be found here, and should also be read prior to set up: Data Management Guidance (Word).
For further information please contact ICTU Data Systems Manager.