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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.
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Yes, if these users are necessary for your research study. However, only users with an active Cerner account can use the CDP feature.
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While you may be able to create an account in KECKCap by authenticating with your USC Net ID, project creation requires specific approval from the KECKCap Administrator, and in most cases the IRB as well. To request project activation from the KECKCap Administrator, team, please complete this form: XXXX.
FDA Studies in KECKCap
FDA studies require very 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.
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