What is KECKCap?
KECKCap is an independent instance of REDCap, meticulously validated for 21 CFR Part 11 compliance, ensuring a secure environment for FDA studies. It is further enhanced with a specialized feature called Clinical Data Pull (CDP), enabling researchers to seamlessly extract data from the Electronic Medical Records (EMR) directly into a KECKCap project. Additionally, KECKCap ensures the secure reception of i2B2 clinical data exports directly into a project.
Why use KECKCap over Research REDcap?
KECKCap is reserved specifically for studies requiring and approved for one of three use cases:
FDA Studies Requiring 21 CFR Part 11 Compliance
For use of the Clinical Data Pull (CDP) feature which allows researchers to extract data from Cerner, directly into a KeckCap project.
For delivery of Clinical Data sets from the Informatics team.
How do I get started?
KECKCap requires explicit IRB approval and a project that necessitates the use of at least one of the three features mentioned above. To request project activation from the KECKCap team, please complete this form: http://tinyurl.com/KECKCapActivation.
Accessing KECKCap
To access KeckCap you must have a valid USC Net ID and access to the Med VPN. Your NET ID will serve as your KECKCap login and password. For information on how to get access to the Med VPN, click here.
Are CHLA and External Users allowed to access KECKCap?
Yes, if these users are necessary for your research study. However, only users with an active Cerner account can use the CDP feature.
FDA Studies in KECKCap
FDA studies require specific procedures and features to maintain 21 CFR Part 11 compliance. If you have an FDA study that you would like to manage out of KECKcap, please submit an FDA study launch request using this form http://tinyurl.com/KECKCapActivation . The support team will reach out to you for consultation and guidance on how to activate your project in KECKCap.
About the CDP Feature
Clinical Data Pull (CDP) is an advanced feature of REDCap that must be enabled by a REDCap administrator. This feature allows an individual REDCap project to interact with an electronic health record (EHR) such as EPIC, Cerner, etc., and pull selected information from the EHR into the REDCap project. This is done through the Fast Healthcare Interoperability Resources (FHIR) web service inside of an EHR which can pull structured data into REDCap using OAuth2 authorization. To learn more about this feature and the type of data available using this resource, please click here.