Regulatory Services
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IND/IDE submission to FDA
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Clinicaltrials.gov registration
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21CFR11 compliance (digital records)
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Submission to UT-IRB (CPHS)
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Other IRB Reciprocity
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Other submissions to FDA
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Data Safety Monitoring Plan Development (DSMP)
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Formation of Data Safety Monitoring Board (DSMB)
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Clinical Trials Resource Center (CTRC) last modified March 21, 2013 |
