Storing Identifiers in REDCap

We recommend the following when considering the storage of identifiers in REDCap.

• Direct identifiers should not be stored in REDCap unless required for data matching purposes.

• For research projects, the storage of identifiers in the project database must be documented in the project's approved ethics application. For projects that do not require REB approval, a Privacy Impact Assessment is required if the project is collecting “Identifiable Healthcare Information”.

• Only the minimum number of identifiers required should be stored in REDCap. 

• REDCap's two-factor authentication (2FA) must not be disabled for the project. (In our REDCap systems 2FA is enabled by default for any user accessing the data from outside of the Faculty of Medicine and Dentistry or AHS networks.)

• Participant data must be allocated a unique identifier other than the ULI/PHN/MRN

• Personally identifying information stored in REDCap must be flagged in the online designer.

• Flagged identifiers should be removed or otherwise de-identified by REDCap during the export process.

• If necessary and depending on project needs, identifiers may be placed on separate forms from less sensitive data. This will allow user rights to be configured so that only certain users have access to the identifiers.

•  Identifiers are not required for analysis and should be removed from the database once data matching and cleaning are complete. 

• In Alberta, if the Principal Investigator is obtaining health information from a custodian such as Alberta Health Services, then the Principal Investigator must enter into a research agreement with the custodian (as defined in Alberta's Health Information Act). This agreement must detail how personal identifiers will be collected and stored.  This agreement must also identify with whom the personal information may be shared and for what purposes. 

Maintaining a Master List

It is common practice for study sites to maintain a master "recruitment" list using a tool such as an Excel spreadsheet.  Here at the University of Alberta HREB suggests that this master list can be maintained in REDCap using a project that is separate from the main study database. 

System Compliance

The installation of REDCap at the University of Alberta is generally considered to comply with the requirements of the Health Information Act of Alberta (HIA). It has been the subject of several privacy impact assessments (PIAs) that have been accepted by the OIPC. REDCap’s compliance with HIA security requirements is documented in this document. More detailed information is contained in our privacy document.

Should identifiers be stored in a separate database?

The formal requirement to store the ULI or other identifiers in a separate database originates from article 3.2 of TCPS (2005) which states "...information that identifies individuals or groups should be kept in different databases with unique identifiers." However, TCPS was superseded by TCPS2 in 2010 and 2014. The relevant section of TCPS 2 (Article 5) contains no such requirement. For this reason, with the approval of the REB, identifiers may be stored in the REDCap project - see the note about data matching above.