The DPMCDA Regulatory Affairs Branch provides consultation and advice on clinical and
non-clinical medication development requirements and strategy to NIDA grantees, contractors,
and other interested parties regarding projects of mutual interest. In addition, the
Branch maintains contact with the FDA to lead filing of IND applications, and NDAs as
new medications enter or complete clinical studies. Regarding safety concerns, the
Branch tracks information to improve NIDA's oversight of clinical trial safety, and to
identify post-marketing safety issues. The Branch monitors patient safety by promptly
assessing serious adverse event reports. An electronic data capture system provides
rapid access to SAE data, including characterizations of severity, relatedness, and
expectedness. A patient profile visualization system allows review of these events
in context of other clinical data about individuals in clinical trails.
This monitoring helps the Regulatory Affairs Branch detect, assess, and understand
adverse events in a timely manner, and to perform regulatory reporting responsibilities.
The Branch also monitors data from post-marketing safety databases, watching for
drug-event combinations that warrant further analysis.
To learn more about the DPMCDA's clinical trial safety oversight initiatives select
from the following areas:
Serious Adverse Event Tracking and Reporting System |
Pharmacovigilance |
Patient Profile/Monitoring Application
Serious Adverse Event Tracking and Reporting System
The Serious Adverse Event Tracking and Reporting System (SAETRS) supports regulatory policy
and procedural requirements of detecting and reporting Serious Adverse Events (SAEs) that may
occur in DPMCDA sponsored clinical research projects. SAETRS provides an automated tool for
clinic personnel to report the occurrence of a serious adverse event and the means to track
information associated with the event as it resolves. The SAETRS system is designed to
automate portions of the reporting of serious adverse events to regulatory authorities
according to 21 CFR 310.305 and 21 CFR 312.32.
NIDA is responsible for monitoring and reporting any occurrence of a SAE to the FDA for all
clinical trials where NIDA holds the IND. Due to the distributed nature of NIDA's
clinical trials conducted by the DPMCDA, NIDA has a consolidated tracking and reporting
tool for managing SAE information, and subsequent reporting to the FDA. SAETRS
complies with CFR 21 Part 11, pertaining to electronic signatures and electronic records,
and is maintained in a state of validation.
The application enables
the input of initial SAE case information, appending medical updates and remarks to the
cases as needed, and provides reports needed to ensure the safety of clinical study
participants and satisfy regulatory reporting requirements for the FDA. In addition,
the SAE data is a resource to examine investigational products across various
populations, indications, doses and other identified safety parameters.
For additional information contact SAETRS Support at (703) 871-8887 (M-F: 9 am to 5 pm EST)
or saetrsprod@imc.com.
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| Features at a Glance |
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Highlights
- Real-Time data entry and reporting
- Automatic AE numbering
- Email notification system
- Case versioning and history (Audit Trails)
- 24/7 system availability
- Dynamic data checks
Reporting
- SAE Specific Reporting
- DSMB Reporting
- Milestones Reporting
- Custom Reporting
User Support
- Support Website
- Dedicated Phone & Email Access
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Pharmacovigilance
NIDA needs to assimilate safety data from clinical studies with post-marketing safety data
to form conclusions about reported side effects of addiction treatment medications.
SAETRS and the Executive Information System (EIS) Safety data mart in the Clinical Data Repository enable data mining and signal
detection techniques for the identification of associations between medications
under study and their adverse drug reactions.
A set of statistical analysis tools applied to post-market public-use safety data
provides insight into potential concerns with both candidate and approved medication
therapies. For already approved drugs that NIDA is researching for potential use in
treating addiction, this knowledge gives a baseline understanding of expected adverse
reactions before a clinical trial even begins providing important knowledge of potential
side effects that study clinicians can monitor. These tools accelerate the discovery of
clinically significant safety issues, allowing NIDA to make rapid, well-informed
decisions about the safety both of trial participants and of patients using approved
medications.
Patient Profile/Monitoring Application
Patient profile visualization facilitates medical review by enabling researchers to see
patient data in a graphical format along a common time axis with annotations. Using this
application, NIDA monitors view the detailed clinical assessment surrounding a specific
adverse event, including other medications, baseline and on-study medical
assessments, patient vital signs and laboratory results, and other adverse events the
trial participant may have experienced.
Such detailed tracking of unusual values or relationships within patient data provide
insights into safety concerns as highlighted by the aggregate level monitoring tools.
The software works directly with the Clinical Data Repository, via the EIS Safety
data mart, and with the SAETRS data, to generate individualized comprehensive patient profiles.
In addition to these participant-level data visualizations, the tool plots various
analytical graphs, for one or more studies. Presentations such as delta graphs and
scatter plots help visualize correlations, distributions of data and drilldown to
individual case profiles available from any of these graphs.
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