The Safety and Pharmacovigilance Team (SPT) within OPCRO serve as subject matter experts and advisors to DAIDS and external stakeholders in matters related to safety and pharmacovigilance. A cross section of DAIDS SPT responsibilities includes:
- Optimizing DAIDS tools for clinical trial safety information and expedited reporting of adverse events, which includes maintaining resource documents such as the DAIDS Grading Table, Expedited Adverse Events (EAE) Manual and training for safety reporting.
- Providing oversight for the DAIDS RSC Safety Office processing of clinical trial safety data for expedited reporting to DAIDS and regulatory authorities.
- Responsible for oversight of safety information distribution to DAIDS clinical research partners, including investigator's brochures (IBs), review of safety memos and supporting the development of safety alerts and notices as requested by DAIDS Programs.
- Overseeing safety data reconciliation between the RSC Safety Office (DAERS Safety Database) and Data Management Centers (clinical databases).
- Providing subject matter expertise in developing policies related to safety reporting.
- Developing, implementing, maintaining and use of a pharmacovigilance system for DAIDS clinical trials to evaluate potential safety issues with study agents.
Should you have any questions or need more information, please contacts the DAIDS Safety and Pharmacovigilance Team (SPT) at NIAIDOPCROSPT@niaid.nih.gov
Related Training Courses on the DLP
|Name||Description and Audience|
|DAIDS Expedited Adverse Event (EAE) Reporting eLearning Course||
Review of DAIDS Expedited Adverse Event Reporting process and the system used for reporting (DAERS). Completion of training is required for access to the DAERS. Those who must use DAERS include Staff members listed as: