Downtime Guidance for Data Collection
To support studies impacted by an outage, investigators should use the following temporary downtime procedures.
If your study uses the impacted service to collect data related to subject safety or to deliver surveys, questionnaires or other data collection materials to subjects, alternative options include:
- Other HIPAA compliant software available at and provided by UNMC (like MS Office or SharePoint)
- Note: for FDA regulated studies, the alternate means of data collection or storage must be compliant with 21 CFR 11 ("Part 11") and with HIPAA regulations.
- Note: for FDA regulated studies, the alternate means of data collection or storage must be compliant with 21 CFR 11 ("Part 11") and with HIPAA regulations.
- Paper forms (stored in a secure and private manner)
DOWNTIME PROCEDURES:
- Send a message to the IRB using RSS portal messaging to request a temporary change and describe the proposed method to collect and store data during the outage.
- The IRB will acknowledge.
- Once the REDCap outage is over, data collection and storage must revert back to what is listed in the application OR a change request must be submitted.
If the impacted service is part of the study's research intervention, please contact the IRB at irbora@unmc.edu to facilitate any needed revisions in the protocol.