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Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.
Detailed summary of the protocol and study results and, if requested, case records or additional background data
Description of the drug substance and drug product, including the components, formulation, specifications, and, if available, the bioavailability of the drug product
Information showing that the effectiveness study is adequate and well controlled under 21 CFR 314.126
The name and address of the IEC that reviewed the study and a statement that the IEC meets the definition in 21 CFR 312.3(b)
Summary of the IEC’s decision to approve or modify and approve the study, or to provide a favorable opinion
Description of how informed consent was obtained
Description of what incentives, if any, were provided to subjects to participate
Description of how the sponsor monitored the study and ensured that the study was carried out consistently with the study protocol
Description of how investigators were trained to comply with GCP and to conduct the study in accordance with the study protocol, and written commitments by investigators to comply with GCP and the protocol
