MNHHS REDCap 2018-09-26T09:09:22+00:00

MNHHS REDCap

Metro North Hospital and Health Service (MNHHS) is committed to enhancing sustainable research capacity through the management and provision of infrastructure and resources to support high quality research. The Metro North Office of Research and MNIT provide MNHHS REDCap free of charge to MNHHS employees under a non-profit end-user license agreement.

REDCap (Research Electronic Data Capture) is a secure web application for building and maintaining online surveys and databases. While REDCap can be used to collect virtually any type of data, it is specifically designed to support online and offline data capture for research studies and operations.

User access requests

All user requests must be completed using the REDCap User Request Form.

Applicants will receive email confirmation of their access request from a REDCap System Administrator. Written notification of the outcome will be provided via return email within five (5) working days.

Applicants will receive access and login instructions via email, including a username (matched to their Novell username), a link to re-set their temporary password and instructions for desktop icon download.

User access is granted for 12 months, and users will be required to re-apply for access on an annual basis, confirm an ongoing MNHHS appointment and acceptance of the terms and conditions of use. The MNHHS REDCap System Administrator will notify users via email 14 days prior to the final access date as a reminder that the account will become inactive.

Acceptance of the MNHHS REDCap Terms of Use is mandatory for all users at the point of application.

MNHHS REDCap may be used for research, quality assurance/improvement or administrative projects, subject to the requisite approvals applicable to each project. MNHHS REDCap is not a tool for clinical patient care. Data collection is for the purposes of approved research or quality assurance/improvement activities only.

It is the primary responsibility of MNHHS REDCap users to ensure data integrity and all requisite approvals are in place. MNHHS REDCap users must comply with relevant privacy legislation, including, but not limited to:

  • Hospital and Health Boards Act 2011 (Qld)
  • Information Privacy Act 2009 (Qld)
  • Public Health Act (Qld)

Furthermore, the management of research data in MNHHS REDCap must be in accordance with the National Statement on Ethical Conduct in Human Research (2007), the Australian Code for the Responsible Conduct of Research (2018), and the ICH Guidelines for Good Clinical Practice.

All research data, including primary materials, are considered to be records of MNHHS and must be stored, disposed of or transferred in accordance with the MNHHS Clinical Records Management and Corporate Records Management policies.

By submitting this MNHHS REDCap user access request I confirm my acceptance of the terms of use:

  • I confirm that I am a MNHHS employee or authorised designated person, and will abide by all relevant legislation, codes of conduct, regulatory guidelines, and MNHHS and Queensland Health policies and procedures governing the terms and conditions of employment, the use of Information and Communication Technology (ICT) services and data management in any medium, including but not limited to:
  • I will not share my MNHHS REDCap login with any other persons, nor authorise any other person to use my MNHHS REDCap login for any reason. I acknowledge that I will be held responsible for all activities conducted with my MNHHS REDCap account.
  • I will ensure that all requisite approvals are in place prior to collecting data in MNHHS REDCap.
  • I will ensure the MNHHS REDCap Project/Database I am building/designing or using will collect and use data in accordance with the approved project protocol or schedule, and the relevant legislation, regulatory guidelines and policies applicable to the protection of privacy and confidentiality.
  • I will not upload, import or collect malicious, illegal or obscene data into MNHHS REDCap.
  • I will ensure that any download or removal of data collected from MNHHS REDCap is managed in accordance with the relevant privacy legislation, in particular Part 7 of the Hospital and Health Boards Act 2011 (Qld) and the Australian Privacy Principles.
  • I will acknowledge the use of MNHHS REDCap appropriately in any manuscripts, papers, publications and public dissemination activities based on data that is collected and managed using the MNHHS REDCap system. Publications resulting from use of MNHHS REDCap to collect and manage data should include“Metro North Hospital and Health Service” as an acknowledgement or the relevant MNHHS institutional affiliation. Please refer to the Metro North Procedure Research: Authorship for further guidance.
  • Publications resulting from the use of REDCAp to collect and manage data must include the following REDCap citation: Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalex, Jose G. Conge, Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr; 42(2):377-81. This reflects the end-user-licensing agreements and is a mandatory condition of use.
  • I accept that the MNHHS REDCap System Administrator will conduct routine and ad-hoc monitoring of MNHHS REDCap, and projects not in compliance with these terms of use may be deleted without warning.
  • I understand that violating the provisions of these terms of use for MNHHS REDCap may constitute grounds for disciplinary actions.

Development mode

All projects will be approved in development mode only, the MNHHS REDCap project/database status where a user designs, builds and tests study instruments. Users may build survey/database tools and seek the requisite approvals before requesting to move a project into production mode and commence data collection. No research, quality assurance/improvement or administrative project will be moved into production mode until the requisite approvals are demonstrated. No project or research data is to be collected in development mode.

Production mode

Production mode is the MNHHS REDCap project/database status where development is complete, the requisite ethical and governance approvals are in place, and the project/database is ready to receive data. Once in production mode, editing the project fields in real time will not be allowed. Edits may still be made in Draft Mode, which will need to be approved by the MNHHS REDCap system administrator before taking effect.

All requests to move a project into production mode will require evidence of the requisite approvals:

  • Research: Human Research Ethics Committee (HREC) approval number, and Site specific assessment (SSA) approval letter confirming the MNHHS REDCap project conforms to the approved protocol and requisite regulatory, legislative and institutional policies; or
  • Quality Assurance/Improvement: Human Research Ethics Committee (HREC) letter of exemption from ethical review, and/or SQU-PROD Quality Action Plan (QAP) Initiative ID

As Principal Investigator (PI) and project owner:

  • I understand my responsibilities as data custodian, and acknowledge the requirement to comply with all relevant data custodianship responsibilities.
  • I will ensure User Rights and Data Access Groups (DAG) are assigned and monitored in accordance with the approved protocol and all relevant data custodianship approvals.
  • I will ensure that all relevant approvals are in place prior to commencing any data collection, and will not collect any data in development mode.

Access

MNHHS REDCap is provided for free to MNHHS employees to conduct approved research and quality assurance/improvement projects by the Metro North Office of Research and MNIT.

Desktop Icon

Instructions for download are available through Queensland Health Online IT Support Self Help article REDCap (Metro North HHS) – Installation.

The website link and desktop icon provide access to the MNHHS REDCap login page only. Individuals are not able to access MNHHS REDCap projects or data until user access is requested and approved.

Projects

Create a project

MNHHS employees with approved REDCap access may request to create a new project using the “+ New Project” tab on the MNHHS REDCap homepage. To finalise the request, click “Create Project”.

Users will receive email confirmation of the request from the MNHHS REDCap System Administrator. Written notification of the outcome will be provided via return email within five (5) working days.

Move a project to production mode

A Project Owner may request to move a project into production mode by:

  1. Go to the ‘Project Setup’ tab located on the project home page
  2. Select ‘move project to production’ located at the bottom of the page
  3. Complete the “Project Production Request Form” automatically generated by the MNHHS REDCap System Administrator and provide evidence of requisite approvals.

The Project Owner will receive email confirmation of the request and written notification of the outcome from the REDCap System Administrator within five (5) working days.

By submitting the request to move into production mode, users acknowledge the requirement to comply with the Production request – user agreement, the approved project protocol or schedule, and the relevant legislation, regulatory guidelines and polices applicable to the protection, privacy, confidentiality and integrity of data.

Production request – User agreement

By submitting the request to move into production mode:

  • I confirm the information provided is true and correct, and all requisite approvals are in accordance with the project/database design.
  • I acknowledge the requirement to comply with the approved project protocol or schedule, and the relevant legislation, regulatory guidelines and policies applicable to the protection or privacy, confidentiality and integrity of data.
  • I will develop and maintain the project/database according to the approved project protocol and ensure the integrity, privacy and protection of all data captured and entered into the MNHHS REDCap project.
  • I understand and will apply my responsibilities as data custodian, and acknowledge the requirement to comply with all relevant data custodianship responsibilities.
  • I will ensure User Rights and Data Access Groups (DAG) are assigned and monitored in accordance with the approved protocol and all relevant data custodianship approvals.
  • Collect only the minimum necessary data in particular, personal health information, required for the study design and administrative requirements of the approved project.

Data custodianship and governance

It is the responsibility of the Project Owner and Principal Investigators (PI) to ensure User Rights and Data Access Groups (DAG) are assigned and monitored in accordance with the approved protocol and all relevant data custodianship approvals.

A Project Owner or Principal Investigator may add approved users to a project, where they have been provided with user access by the MNHHS REDCap System Administrator, and the relevant governance and approvals are in place. Approved users may be added by selecting the “User Rights and DAGs” link under the Project Applications menu.

Collaborative Research

Queensland Health Staff Access

Queensland Health employees may request access to MNHHS REDCap using the online survey REDCap User Request Form. Users will be required to agree to the MNHHS REDCap terms of use, and will be bound by the same privacy and data management frameworks as MNHHS employees.

Only a MNHHS employee may request to create a project and be a Principal Investigator (PI) and project owner. It is the responsibility of the PI to ensure that all users are assigned the appropriate data access group (DAG) based on their authorised delegation and data access privileges.

Non-Queensland Health User Access

Where an individual is not a MNHHS employee, they may still be eligible to request access to MNHHS REDCap.

For research projects, the individual must demonstrate evidence of their status as a designated person for data access and usage, with either the appropriate ethics (HREC) and governance (SSA) approvals, as listed investigators on the project for which they request access, or other relevant approvals. This must be submitted with the request for access, and approvals must be in place before any user will be granted project access.

Please note, where the individual is requesting access to a MNHHS REDCap project and also requires access to the QH network, they must demonstrate an appropriate agreement, thereby accepting all terms of engagement with MNHHS and conditions of access to research data as a designated person. Please refer to the Procedure Research: Honorary appointments, research students and visitors (PROC004418) for further information.

Support

MNHHS REDCap infrastructure is independently maintained and supported by MNIT, and is hosted on local servers under a non-profit end-user license agreement.

The MNHHS REDCap System Administrator will provide administrative support for the MNHHS REDCap to facilitate access requests, and is the first point of contact for assistance.

The MNHHS Office of Research, Metro North IT and MNHHS REDCap System Administrator will not provide guidance on survey or database design, or advanced functionality of REDCap.

Support is accessible via the REDCap Community Training Resources website, which hosts the REDCap Shared Llibrary and REDCap tutorial videos. Statistical support for designing research methodology, planning and/or conducting data analysis can be provided by the QIMR Biostatistics Unit, upon request.

MNHHS is committed to ensuring the integrity, privacy and confidentiality of all data is protected, whilst assisting those MNHHS staff and individuals authorised to access REDCap to conduct approved research and quality assurance/improvement activities. The protection of research data and personal information which may be contained in REDCap databases requires that researchers and authorised users abide by the relevant legislation, regulatory guidelines and institutional policies that govern the collection, management, disclosure and use of research data and personal information.