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ClinicalTrials.gov Reporting |
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Four of FDASmart Training Classes |
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Class Title |
Description |
1 |
Understanding the Requirements for Entering Protocol Data into ClinialTrials.gov |
Understanding the new requirement to enter study protocols data into the ClinicalTrials.gov web site. |
2 |
Understanding the Requirements for Entering Clinical Trials Results into ClinialTrials.gov |
A discussion of the requirements of all FDA regulated companies to enter clinical trial results into www.CinicalTrials.gov |
3 |
Implications and Key Points About the Certification of Compliance |
A 30-minute update discussing FDA’s requirement for submissions to include a Certification of Compliance (Form FDA-364) confirming that protocol information has been entered into www.CinicalTrials.gov. |
4 |
FDA’s New Definition of an “Applicable Trial” |
A 30-Minute Update that reviews the content of FDA’s December 8, 2008 document intended to explain the agency’s interpretation of an “applicable clinical trial”, a study whose protocol and results must be entered into ClinicalTrials.gov |
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