Manage a REDCap project2020-08-19T15:15:35+10:00

Manage a REDCap project

Data Management

Metro North data collected via REDCap accessed through other organisations will be stored on the server at that organisation. While this is not ideal, ownership of Metro North data remains with Metro North (subject to study agreements). Researchers are encouraged to transfer data held in REDCap platforms at other institutions to Metro North REDCap, after which researchers should request that the project be deleted from the REDCap at the other organisation as well as backups.

Data Retention and Archiving

REDCap is primarily a data collection tool and is not specifically intended or designed for long-term storage or archiving of study data. It is suggested that at the end of any study, the following activities be undertaken:

  • Download and store copies of the project data dictionary and exported data.
  • This should be archived according any specified agreement or storage requirements. Remove all users from the project who no longer require access.
  • ‘Archive’ the project in REDCap as per the instructions on the ‘Other Functionality’ page.

Privacy, Confidentiality

All Metro North REDCap users must comply with any relevant state and federal privacy legislation. The below information is provided with regard to the collection and management of data for the purposes of approved research or quality improvement/audit purposes.

This information is not intended to provide a definitive authority on the subject of privacy and is to be used for guidance only. REDCap users must ensure they are aware of and informed of all requirements as they relate to data collection, storage and sharing.

Research Projects

A Human Research Ethics Committee (HREC) will review ethical considerations for collection, management and protection of privacy for research data. Where identifiable patient information will be included in a REDCap project, this should be documented in the HREC submission and approval.

A Metro North Research Governance Officer (RGO) will also review research data privacy, ownership, sharing and archiving to ensure that research data will be collected, used and maintained according to applicable legislative, regulatory and policy requirements, and in accordance with HREC approval.

The Principal Investigator must ensure all requisite approvals (HREC and SSA) are in place and the REDCap project complies with the approved protocol.

Compliance with specific requirements of a HREC and/or Research Governance Officer regarding the use of REDCap is mandatory.

Quality Improvement and Operational Projects

A Quality Improvement (QI) or Operational Project may receive a written exemption from ethical review by a HREC. It is the responsibility of a Project Owner to determine whether a QI or operational project requires submission for classification and review by a HREC.

The Project Owner is responsible for ensuring that all aspects of a project comply with applicable legislative, regulatory and policy requirements.

The Project Owner and investigative team must ensure that adequate steps are taken protect the privacy of the project data, and ensure compliance with state and federal legislation regarding health information and privacy.

All QI projects must be registered with the Metro North Safety & Quality SQU-PROD Quality Action Plan (QAP) database and record the Initiative ID.

HREC & Governance Approval

Suggested application wording

REDCap (Research Electronic Data Capture) is a secure web application used exclusively to support data capture for research studies. Metro North has installed the REDCap software on its server.

REDCap provides:

  1. An intuitive interface for validated data entry (with data validation);
  2. 256-bit encryption between the data entry client and the server;
  3. Individual access to the database via secure login;
  4. An audit trails for tracking data manipulation and export procedures;
  5. Automated export procedures for data downloads to common statistical packages (SPSS, SAS, Stata, R et.);
  6. Procedures for importing data from external sources; and
  7. Advanced features such as branching logic, calculated fields and data quality checks.

REDCap is developed and maintained by a team at the Vanderbilt University and licensed free of charge by Metro North.

The Metro North instance of the REDCap application and data are housed on a Metro North server. The database is securely backed up every 24 hours.

The project database will be created in the Metro North instance of REDCap. Data collection and storage will comply with all applicable requirements including:

  • Ethical and governance approvals
  • Applicable Australian state and federal legislation including privacy legislation
  • Metro North policies and procedures

Projects where patient identifiers will NOT be stored

As per the approved protocol, study participants will be allocated a unique study code and identifiers will not be used in the study database. Documents linking the study participant to their unique study code will be stored separately .

REDCap provides individual access to the database via secure login to the Metro North REDCap instance as well as audit trails for tracking data manipulation and export procedures.

Projects where patient identifiers will be stored

As per the approved protocol, study participants will be allocated a unique study code and identifiers will also be entered into the study database.

Email addresses and other contact information will be stored in the same project database as participant survey responses. This is required by the REDCap software in order that personalised survey invitations may be emailed to the study participants.

Identifiers will be flagged as ‘identifiable’ in REDCap which provides additional protection for these data elements. Data marked as an identifier will only be available to specified individuals or user roles on the project. Identifiers will automatically be removed from printed or exported material generated by REDCap where the user does not have permission.

REDCap and collaborative project agreements

Where more than one party (outside of Metro North) is involved in a research project, an agreement will be required. Agreements include terms and conditions relating to the ownership and protections of existing information and information created during the project. Where REDCap is used, the agreement should also outline the following information:

  • The organisation that will host the REDCap database (this may not always be Metro North) used to collect and store the project information.
  • Whether the collaborating organisation(s) will host their own duplicate or connected REDCap databases.
  • User access permissions for persons from the organisation(s) such as identifiers, adding data, deleting data, download of data etc.
  • Whether the collaborating organisation(s) will be provided a copy of the final data set.
  • In what format the data will be provided to the collaborating organisation(s) (ie. coded, partial data set only).
  • How long the data will be stored by all parties.
  • How the data will be stored by all parties.
  • Details of the data sharing and access plan for the active study phase and after project closure.