All REDCap projects begin in Development mode. After the project is developed and tested, the project must be moved to Production mode before collecting "real" data.
Per regulations,
- For research projects, be sure to obtain approval from the proper regulatory offices, such as SBU IRB, RDRC, etc.
- For QA/QI projects, be sure to complete the "QA vs. Research" application to ensure the project is properly designated and vetted. All QA projects are expected to be authorized by a departmental QA board or the SBM Chief Quality Officer and adhere to appropriate ethics and processes (e.g., quality plan document defining goals, metrics, endpoints, etc.). For more, please review SBU's Quality Improvement SOP as well as Requirement 2 below.
Benefits to Moving Your Project to Production
- Moving a Project to Production helps to ensure long-term accessibility, data protection, compliance, and a limited degree of support for your REDCap project.
- When making changes in production, REDCap offers built-in checks to safeguard against unintentional data loss caused by, for example, deleting a field, changing a field type, altering a multiple choice option, rewording a field prompt:
- A "summary of changes" page will become available, displaying a preview of all the fields that are added, removed, and modified, and drawing attention to changes that could result in data corruption or deletion.
- Changes that are considered 'higher-risk' are forwarded to the REDCap Support Team for approval before taking effect. The vast majority of change requests are approved (or responded to) within 1 business day.
- Each approved revision to the data dictionary (instruments and/or field definitions) is archived, tracked, and can be compared with other revisions in a detailed view.
- The number of *Production* projects is reported weekly and is cited to justify continued support for REDCap at Stony Brook.
- The retention of data is not guaranteed for projects in Development mode, depending on the storage and performance maintenance needs of projects in Production. Data in Production and Post-Production projects will remain secured.
- Projects that are capturing "real" data in Development mode do so at their own risk. Given the higher risk of data loss/corruption as well as their unverified status, REDCap administrators will be unable to assist with restoring user access, tracking down lost data, etc. in Development-mode projects.
Requirements for Move to Production
All projects submitted for Production status are required to meet basic documentation requirements, to verify compliance and enable administrative oversight.
Before submitting your request, please use the following checklist to ensure your project is approved expediently:
|
Number |
Requirement |
Why is this required? |
| 1 |
Under "Modify Project Settings," select an accurate Purpose for your project.
Projects labeled "Just for Fun" are not moved to production in this system. |
Helps the REDCap team better understand the project and determine what requirements to look for. |
|
2 |
A) For research projects, an approved IRB number is required (under the Project Setup > "Modify Project Settings" pane.)
B) For QA/QI projects, required is a copy of the approval letter/email signed by the Office of the CQO acknowledging that the project can be conducted. Attach a copy of the *original* approval email by dragging-and-dropping the email to your message window in Outlook, and address it to REDCapAdmins@stonybrookmedicine.edu, CC'ing your faculty project director. (Only original emails addressed from the approver are accepted—we are unable to accept forwarded emails.) For further guidance, please review the SBU standard operating procedures for QA/QI projects. C) For small-scale, low-risk operational projects (not Research, QA, or clinical), provide: a description of its purpose, expected number of records, planned completion date, and faculty-level supervisor in the "Project Setup > Modify project settings" pane. ** For clinical projects, please note that SBM REDCap is not approved to be used in clinical care or operations due to auditing and support concerns, regardless of whether the data will be used for research at some point in the future. REDCap may only be used to capture data in QA/QI projects, Research studies, and small-scale, low-risk internal survey projects with well-defined endpoints, as described above. |
Verifies that the project operates aboveboard and has received approvals from institution-sanctioned regulatory bodies such as the IRB and Office of the Chief Quality Officer (CQO). Ensures that shared IT resources are directed toward projects that meet compliance requirements and align with institutional missions. |
|
3 |
Faculty-level director or P.I. has been granted access with *User Rights* privileges to the project.
(More information on the user onboarding process is available in our access guide.) |
Helps prevent projects from becoming "orphaned" due to employee turnover; ensures projects remain available to the appropriate personnel. Confirms project director's awareness of and participation in the project. (Project directors and PIs are ultimately responsible for safeguarding/custodianship of the data collected in their studies.) |
|
4 |
HIPAA-controlled PHI fields, (names, dates, MRNs, etc.) are flagged as "identifiers." This includes Age fields, unless the age field is validated as an "integer" and all entries in this field are expected to fall under 90 years old. (Project Setup > "Check for Identifiers" link)
|
Safeguards against data breach by placing PHI fields in a higher sensitivity tier, in which only users with "full data set" permissions are able to export data from these fields (via the "Data Exports, Reports, and Stats" application). Allows administrators to monitor how many projects are capturing sensitive data elements (and which elements are being captured). |
|
5 |
Requestor is listed as a P.I. or Study Team member on the project's IRB protocol.
|
Verifies link between the REDCap project and its IRB record. Confirms project is being Moved to Production by a documented member of the study team. |
When ready, proceed by clicking Request for Move to Production at the bottom of the Project Setup page to submit your project for review:
It usually takes 1-2 business days to approve a move to production request that meets all of the above requirements.
* Please note: This process checks only for the documentation required to move to production. For a technical review of your project design, or for suggestions on how best to design your project to meet your needs, feel free to get in touch with the REDCap support team at REDCapAdmins@stonybrookmedicine.edu. In your message, be sure to include any project documentation, such as an IRB protocol or QA project plan, as well as your REDCap project ID (PID), if it exists.