Initial Considerations
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Study personnel develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks.
establishment Establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures
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project PI is responsible for ensuring both the above requirements are met throughout the life of their study. |
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The Process
Register project in: Protracks System
Select the below services:
Biomedical Informatics Core (REDCap Project Request)
Biomedical Informatics Core (21 CFR Part 11 Validated Request)
To complete the initial registration process for [validated projects] there will be total of 3 forms which need completed:
CTSI Services Requested
CTSI Project
BMIC Project Information
Upon selection of [21 CFR Part 11 Validated] service, a BMIC help ticket will be opened for support
The BMIC team will then review your request, and if all forms are adequately completed, a PI-Sign-Off form will be sent to the PI provided within the ‘Project Information’ form
Once PI Sign-Off is captured, the BMIC team will communicate with key personnel using the BMIC help ticket to proceed
Additional Considerations
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