Long-term regulatory maintenance services provided by the CRDOC regulatory unit include:
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Liaison with industry sponsors for all regulatory matters related to specific studies.
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Updating general information for submission to the FDA, IRB, VA, Markey Cancer Center, and Institutional Biosafety Committee, where applicable.
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AE/SAE reporting to the FDA, IRB, VA, Markey Cancer Center and Institutional Biosafety Committee, where applicable.
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Amending protocol and investigator drug brochure, including revising FDA and IRB documents for submission to the FDA, IRB, VA, Markey Cancer Center, and Institutional Biosafety Committee, where applicable.
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Reporting of protocol violations and deviations to the FDA, IRB, VA, Markey Cancer Center, and Institutional Biosafety Committee, where applicable.
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Preparing continuation and final reviews and progress reports for submission to the FDA, IRB, VA, Markey Cancer Center, and Institutional Biosafety Committee, where applicable.
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