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The InForm CRF Submit 3.1.6 application is designed for deployment as part of a validated system that is compliant with GCP predicate rule requirements, laws, and regulations applicable to the conduct of clinical studies, and FDA 21 CFR Part 11 pertaining to the use of electronic records and signatures.
The PDF output of the CRF Submit application is designed according to ICH eCTD guidance. Oracle solicited feedback from the FDA to ensure that the PDF file output is organized and navigable according to both CBER and CDER preferences. The user of the CRF Submit application is ultimately responsible for the success of the submission with regulatory agencies.
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