REDCap

REDCap at the University of Melbourne

REDCap (Research Electronic Data Capture) is a secure web-based platform that is designed to capture research data and is available for use in University of Melbourne research free of charge. Particularly successful within clinical and translational research enterprises, REDCap at the University of Melbourne has in excess of 400 active users and 180+ projects with strengths in survey design and implementation and randomisation available.

If you are unsure about the kind of electronic data capture databases you need there are numerous publications.

Support and Training:

REDCap provides comprehensive support to users via on-line training materials. Additional support is available via workshops and technical support for complex queries. For access and trouble shooting please e-mail ) red-cap@unimelb.edu.au. Alternately for general queries about Health Informatics and data acquisition contact the MCATS manager using mcats-info@unimelb.edu.au.

Citations:

Study manuscripts using The University of Melbourne REDCap instance for data collection and management must acknowledge The University as follows: “Study data were collected and managed using REDCap electronic data capture tools hosted at The University of Melbourne”

If you are using the MCATS services, citations in any scientific papers and reports that result from research projects supported by the services of the Melbourne Clinical And Translational Sciences (MCATS) research platform expected to mention MCATS using the following wording “AUTHOR(S) would like to thank MCATS (Melbourne Clinical And Translational Sciences research platform), for the administrative and technical support that greatly facilitated this research.”

REDCap support includes:

  • Receipt and processing of completed REDCap application forms including;
    • new and bulk REDCap users
  • Verification and Implementation of approved production projects
  • Reset of lost passwords
  • Server hosting (via Research Cloud) of REDCap projects
  • Backup and maintenance of REDCap overall site project data (via weekly snapshot)
  • HaBIC R2 in collaboration with MCATS provides REDCap administration and training support.

Availability:

Planned outages for systems maintenance may be programmed from time to time. A minimum of 7 days advance notice of such events will be provided via email to registered users. System availability is targeted to be 99.9%. In the event of an unplanned outage some data loss may occur i.e. records entered on the day of the fault arising.

Disclaimer

  • Data Custodianship:
    Clinical Investigators retain accountability for data custodianship, including conformance to the National Statement on Ethical Conduct in Human Research.
  • Access to REDCap:
    All applicants for Project Create/Modify Permission must complete and submit a relevant Application form. Once an individual is granted Project Create/Modify Permission they can add new user accounts (data entry only) to their project through filling in and sending back the Bulk User Import Template.
  • Compliance:
    It is the responsibility of the researcher to comply with all Australian State and Federal legislation - and this includes the use of person identifiers, privacy legislation and data protection laws. For international studies, further compliance may be necessary. University of Melbourne employees must conform to University of Melbourne Research Policy. Please see Management of Research Data and Record Policy (MPF1242) and related policies. Please see www.comlaw.gov.au, www.nhmrc.gov.au and https://www.australianclinicaltrials.gov.au for additional resources. REDCap is a free, secure, web-based application designed to support data capture for research studies. The system was developed by a multi-institutional consortium initiated at Vanderbilt University.
  • Data Retention Compliance:
    The REDCap repository is not designed for long-term data retention. At the end of a study it is the researcher’s responsibility to conform to retention of data guidelines by archiving data independently of REDCap.
  • Project and Data Backup:
    It is the researcher’s responsibility to ensure backups of their project template and data are performed and maintained, at intervals determined appropriate for the project. The storage of the project metadata and data are to be kept secure by the researcher and the researcher retains accountability for the data retention and custodianship.
  • Compliance notes with specific relevance to questionnaire design:
    • IDENTIFIABLE DATA: Where data collected is person-identifiable, Privacy Legislation applies
    • ETHICS AND CONSENT: Regardless of legislation, in research involving humans, you should always try to implement the best practicable mechanism of informed consent. This must be addressed in questionnaire and project designs. Please see the National Statement on Ethical Conduct in Human Research
    • Good Clinical Practice guidelines validated and adhered to for Therapeutic Good Administration (TGA) Trials: It is the responsibility of the researcher to ensure that their research study collection forms for all all TGA clinical trials that have human subject participants, adhere to and validated against the GCP guidelines
    • MEDICARE ID: The Australian Medicare ID is constrained by specific legislation and its use for secondary uses of data (research) is NOT permitted.
    • US FDA 21 CFR Part 11: REDCap is not compliant to this standard.
    • EU General Data Protection Regulation (GDPR): this REDCap platform is not  compliant at this time.
    • US HIPAA regulations: REDCap is designed to comply, however the compliance of our instance has not been verified. It is the responsibility of the researcher that their study complies with HIPPA regulations, if applicable.