Pharmacovigilance and Safety in Clinical Trials
Overview of DMID's Centralized Pharmacovigilance Program
DMID has centralized safety information gathered in all DMID-sponsored clinical trials involving greater-than-minimal risks in human subjects. Previously, all safety information resided in various databases. With the initiation of the Clinical Trials Management System and in conjunction with our Clinical Trials Management (CTM) contractor, PPD Development Inc., the Office of Clinical Research Affairs (OCRA) collects all serious adverse events (SAEs) in a centralized location at the CTM. All clinical studies involving human subjects, and with interventions considered to be greater-than-minimal risk are included in the pharmacovigilance system. It is expected that the SAE database will be a resource to DMID as we gain the capacity to look at investigational products across various populations, indications, doses, etc.
All investigators are instructed to direct SAEs to the CTM via fax, telephone, or electronic transmission where they will be tracked and distributed to the appropriate parties (Protocol Champion, ORA, OCRA, medical monitors, etc.) at DMID. Investigators have access to an SAE “help line” which allows them to get real-time clarification regarding the SAE reporting process and their own specific questions.
If DMID is the IND sponsor, all reporting will comply with 21 CFR 312. All studies not being conducted under IND should meet the reporting requirements set forth in ICH E6 Good Clinical Practices and other associated guidelines. Studies conducted under another sponsor’s IND will have the safety data transferred to DMID's CTM contractor and will be reconciled at the end of the study.
For any questions, please contact Wendy Fanaroff, OCRA at 301-451-3027 or our pharmacovigilance contractor at 1-800-201-8725.
SAE Reporting Guidelines and Forms
SAE Reporting Guidelines and Forms
Toxicity Tables
Toxicity Tables: DMID Adult and Pediatric Toxicity Tables and links to toxicity tables used by other clinical groups
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