Research data and metadata must be collected, stored, retained, used and disposed of in a manner that protect the rights, safety, and well-being of the research participants and the wider community, maintains data security and integrity, and is in accordance with all applicable requirements.

Using REDCap can help meet these data requirements.

Why use REDCap?

REDCap (Research Electronic Data Capture) is a secure web application for building and managing online surveys and databases. The system was developed by a multi-institutional consortium based at Vanderbilt University, but is hosted on Melbourne Health servers and managed by the Business Intelligence Unit

While REDCap can be used to collect virtually any type of data, it is specifically geared to support online or offline data capture for research studies (including clinical trials) and operations. Data collection is customized for use (study or clinical operation) by the users.

Melbourne Health encourages its staff to use REDCap for operational and research purposes as the data is held at Melbourne Health and the system and security is managed in accordance with Melbourne Health Business Intelligence Unit and Information Technology (IT) systems and protocols.

REDCap provides:

  • An intuitive interface for validated data entry;
  • Audit trails for tracking data manipulation and export procedures;
  • Automated export procedures for data downloads to common statistical packages; and
  • Procedures for importing data from external sources.

Important Notes:

  • Data collection, storage and use must remain compliant with approvals and any other applicable requirement, irrespective of the data formats and tools used to collect and manage the data.
  • Melbourne Health data collected via REDCap accessed through other organisations will be stored on the server at that organisation. While this is not ideal, ownership of Melbourne Health data remains with Melbourne Health (subject to study agreements). Researchers are encouraged to transfer data held in REDCap platforms at other institutions to Melbourne Health REDCap, after which researchers should request that the project be deleted from the REDCap at the other organisation as well as backups.

For further information and history of the database refer to the REDCap consortium webpage.

Why you shouldn’t rely on Excel!

Excel is a great tool for collecting data simply and quickly. Anyone can do it and that is one of its greatest strengths. Unfortunately, it is also its biggest weaknesses. Anyone can do anything they want in Excel with no consideration for security, privacy, data quality or audit trail. Using a tool such as REDCap can overcome these problems.

Why use REDCap instead of Survey Monkey?

Great question. They both collect survey data right? It's all about data traceability and security, and for this reason Melbourne Health no longer supports the use of Survey Monkey for new surveys. For new surveys, staff are encouraged to use RedCAP.

REDCap is hosted on Melbourne Health servers so the data stays at MH. REDCap is a web based application so is accessible from outside of the organisation and you can share results with collaborators.

Accessing REDCap

Access is via secure login to the Melbourne Health REDCap portal .

Melbourne Health staff can request a REDCap database login from the Melbourne Health REDCap administrator. Click here to request a login.

External persons requiring access to the Melbourne Health REDCap database to undertake project activities to must be sponsored by a MH employee (study Principal Investigator or Coordinator). Access can be requested at the same site as for Melbourne Health users. Request access to MH REDCap.

REDCap is available for use by Melbourne Health employees and affiliated researchers free of charge. However, if you require help developing a specific study a cost may be incurred. Please contact the REDCap administrator via the REDCap Portal for further information regarding any custom development, REDCap extensions and plugins, integration, data extraction or project review.

REDCap Support

Technical support

For technical support for complex queries please email the Melbourne Health REDCap administrator via the REDCap portal.

Technical support includes:

  • Processing requests for access to the platform.
  • Approval of projects for migration from development into production.
  • Review of changes to projects already in production to ensure no data is lost.
  • Reset of lost/out of date passwords.
  • Server hosting of REDCap projects.
  • Backup and maintenance of REDCap overall site project data. Frequency of onsite backup is four times per day. Off-site back up is conducted as per Melbourne Health standard secure processes.
  • Speciality builds for specific projects (fees apply).
  • Extraction of data/data sets collected via other MH platforms (fees apply).

For technical support for complex queries please email the Melbourne Health REDCap administrator via the REDCap protal.

For more information refer to the REDCap consortium webpage.

Training

There are various avenues for training in the system:

  • The software is designed to be intuitive and REDCap itself provides comprehensive support to users via “How to” instructions and videos embedded into the platform.
  • Melbourne Health provides additional support via REDCap support group sessions.
  • FAQs sheet – refer to the FAQ sheet for answers to common questions about REDCap at Melbourne Health.
  • User guides - Melbourne Health has not developed specific user guides. However, there is a large amount of help and information available from many institutions who have created user guides. If you have a query, type it into an internet search engine and you will find many sources with step-by-step instruction for the most commonly used features of REDCap.

Additional resources

Useful links

Is there a cost to use REDCap?

REDCap is available for use at MH free of charge.

However, if you require help developing a specific study a cost may be incurred.

Please contact the REDCap administrator via the REDCap protal for further information.

System Availability

REDCap is a secure web based application that is accessible internally and from outside of Melbourne Health.

System availability is targeted to be 99%.

REDCap is updated approximately monthly which requires REDCap to go offline for approximately 30 mins. This ensures users have access to the latest tools, and security is continually improved.

Notification for planned outages are generally issued to all MH REDCap users in advance of the outage.

During an unplanned outage, it is highly unlikely that any data will be lost.

Privacy Issues

The below information primarily relates to collection and management of data for research purposes or quality improvement studies. It is for guidance only and is not intended to be a definitive authority on the subject of privacy.

Legal Responsibilities

All users of REDCap must comply with appropriate state and federal privacy legislation.

MH staff and projects must also comply with MH policy and research governance requirements including:

  • Research policy MH 18 (access via iPolicy)
  • Intellectual Property Policy MH12 (access via iPolicy)
Projects with HREC and Governance Approval

The HREC is responsible for ensuring that the research team is taking adequate steps to protect the privacy of the research data. Patient identifiers may be included in the project database provided that these identifiers have been documented in the HREC submission.

Melbourne Health Research Governance Officers will also review data privacy and other data issues such as ownership, sharing and archiving, to ensure that research data will be collected, used and maintained according to applicable requirements and the HREC approval.

Researchers must comply with any specific requirements mandated by the HREC and/or Melbourne Health Office for Research.

The Principal Investigator is responsible for ensuring that all aspects of the project comply with all applicable legislative and other requirements including HREC and Research Governance requirements.

Quality Assurance Projects including Operational Projects

Projects such as Quality Assurance projects and quality improvement studies typically do not have HREC approval but may require review and confirmation of classification as a quality assurance project

Principal Investigators and study teams must ensure that the project includes adequate steps to protect the privacy of the research data and that the project complies with all applicable state and federal requirements, including privacy.

The Principal Investigator is responsible for ensuring that all aspects of the project comply with applicable legislative and other requirements.

Important Notes:

It is the responsibility of the project lead to determine whether the quality assurance/quality improvement project requires review and confirmation of classification as a quality assurance project by the Office for Research.

Project leads should refer to the Quality assurance application page of the Office for Research website to review the Quality assurance management and approval process.

REDCap and Privacy

It is the users responsibility to ensure that they manage data (use collect, use, store, share etc.) in accordance with all applicable requirements and approvals including privacy requirements.

REDCap provides a number of features that are designed to protect the privacy of research participants including:

The MH copy of the REDCap application and data are housed on MH. The database is securely backed up off site as per standard hospital procedures for data security. Local support is provided by MH.

Use of 256-bit encryption between the data entry client and the server.

Individual access to the database via secure login.

Audit trails for tracking data manipulation and export procedures.

Disclaimer - User Responsibilities

The database structure and content is maintained by the database custodian (i.e. MH Principal Investigator [or delegate] or other staff member (for operational activities).

Database custodian are responsible for the conduct of the entire research study at the site including for management and custodianship of data throughout the entire data life cycle.

Database custodian should ensure that data is managed in accordance with good documentation practices and that studies are conducted in accordance with all applicable laws, guidelines and requirements including but not limited to:

Disclaimer - Data ownership

Project data ownership is in accordance with the Intellectual Property Policy MH12 and any applicable agreements.

Project data held in REDCap must not be shared with external parties unless (1) data sharing complies with HREC and research governance approvals, and (2) there is an agreement that outlines the arrangement.

Useful links:

Disclaimer - Agreements for collaborative projects

The MH requirement is that an agreement is required when more than one party is involved in a research project.

Project agreements must include terms and conditions relating to all areas of the project including ownership and protection of existing information and information created during the project.

Where REDCap is used the agreement should also define database information such as:

  1. The organisation that will host the REDCap database used to collect and store the project information.
  2. Whether the collaborating organisations will hold duplicate REDCap databases on their own organisations REDCap.
  3. Permissions for persons involved on the project from each organisation such as:
  • access identifiers
  • add data
  • alter data
  • read etc.
  1. Whether the collaborating organisations will be provided a copy of the final data set.
  2. What format the data will be provided to each organisation (coded, identified)
  3. How long the data will be stored.
  4. How the data will be destroyed.
  5. Details of the data sharing and access plan for after the active phase of the study has been completed.
Disclaimer - Maintain current project access to REDCap:

Database custodians are responsible for ensuring that access to REDCap is only provided to appropriate persons involved in the study and permissions are appropriate to the individual’s role on the study.

Database custodians should regularly review and remove users who no longer require access to the study.

Disclaimer - Ensuring Compliance

It is the responsibility of the database custodian to determine which requirements are applicable to a particular project, including all applicable Australian State and Federal legislation, and also that those requirements are met when using the REDCap platform. This includes privacy issues such ass the use of personal identifiers, privacy legislation and data protection laws. For International studies, further compliance may be necessary.

MH employees must also conform to MH policies, associated guidelines and requirements as applicable to the database (research or organisational).

The design of the REDCap system has the capability to be compliant with applicable legislative requirements in various jurisdictions i.e. REDCap is designed to comply with HIPAA regulations, but it is not generally considered to be 21 CFR Part 11 compliant.

However, compliance is not guaranteed by use of the system per se and compliance of our instance has not been verified. It is the responsibility of the user to ensure that their study, including use of REDCap complies with HIPPA or other regulations, as applicable.

Disclaimer - Data Retention and Archiving

REDCap is primarily a data collection tool and is not designed for long-term storage or archiving of study data.

MH’s current policy is that studies will remain in REDCap indefinitely.

However, at some point in the future if data storage becomes an issue, we will undertake housekeeping and will remove old projects. At this point users will receive notification prior to the start of housekeeping activities that remove old projects.

At the end of a study it is suggested that you undertake the following:

  1. Download copies of the project data dictionary and exported data. This should be archived on the MH Principal Investigators departmental drive on a MH server. The storage location of the REDCap data and supporting metadata (other project information i.e. protocol, PICFs etc.) is recorded and the data remains at MH and is accessible.
  2. Store the downloaded copies of the project data dictionary and exported data in your research project or operational files.
  3. Remove and users from the project who no longer require access.
  4. “Archive” the project in REDCap as per instructions on the projects “Other Functionality” page. This will remove the project from the “My Projects” list of all users unless they choose to “show archived projects”.
Examples of text to include in Ethics and Research Governance Applications

The following text are examples of what may be suitable to modify for use in the project ethics and research governance applications.

Note:

  • Standard text should not be altered.
  • Text italic should be amended to the project specific requirements.
Example A:
The below wording may be used for studies where participant identifiers are not stored in the REDCap project database. Note, the wording in blue italic should be amended to the project specific requirements.

REDCap (Research Electronic Data Capture) is a secure web application used exclusively to support data capture for research studies.

Melbourne Health 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 Melbourne Health (MH).

The MH copy of the REDCap application and data are housed on MH. The database is securely backed up every six hours.

The MH copy of the REDCap application and data are housed on MH site as per standard hospital procedures for data security. Local support is provided by MH.

The study database will be created in REDCap hosted by MH. Data collection and storage will comply with all applicable requirements including:

  • Ethical and governance approvals
  • Applicable Australian state and federal legislation including privacy legislation
  • MH policies and requirements

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 in a locked filing cabinet. REDCap provides individual access to the database via secure login to the Melbourne Health REDCap portal as well as audit trails for tracking data manipulation and export procedures.

Example B:
The below wording may be used for studies where participant identifiers will be stored in the REDCap project database. Note, the wording in blue italic should be amended to the project specific requirements.

REDCap (Research Electronic Data Capture) is a secure web application used exclusively to support data capture for research studies. 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 Melbourne Health (MH).

The MH copy of the REDCap application and data are housed on MH. The database is securely backed up off site as per standard hospital procedures for data security. Local support is provided by MH.

The study database will be created in REDCap hosted by MH. Data collection and storage will comply with all applicable requirements including:

  • Ethical and governance approvals
  • Applicable Australian state and federal legislation including privacy legislation
  • MH policies and requirements


As per the approved protocol, study participants will be allocated a unique study code and identifiers will also be entered into the study database.
The database will be configured to management participant identifies as follows:

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

Identifiers will be flagged as such in REDCap which then provides additional protection for these data elements

Identifiers will only be available to specified individuals or user roles on the project.

Identifiers will automatically be removed from all printed or exported material generated by REDCap where the user does not have permission to identifiers.

Example of text to include in Grant Applications
The following text us an example of what may be suitable to use in a grant application:

REDCap (Research Electronic Data Capture) is a secure web application used exclusively to support data capture for research studies. 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) audit trails for tracking data manipulation and export procedures; 4) automated export procedures for data downloads to common statistical packages (SPSS, SAS, Stata, R et.); and 5) procedures for importing data from external sources; and 6) 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 Melbourne Health. The application and data are housed on servers provided by Melbourne Health. The database is securely backed up off site as per standard hospital procedures for data security. Local support is provided by Melbourne Health.

Citations for Publications

Study manuscripts or other publications using the Melbourne Health REDCap for data collection and/or management must acknowledge Melbourne Health as follows:

“Study data were collected and managed using REDCap1 electronic data capture tools hosted by the Royal Melbourne Hospital Business Intelligence Unit.”

1Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research

Related links