FDA, MIH Launch Electronic Safety Reporting Portal | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

FDA, MIH Launch Electronic Safety Reporting Portal

May 26, 2010
by root
| Reprints

The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have launched the Safety Reporting Portal (SRP), a Web site that will eventually allow for the reporting of pre- and post- market safety data to the federal government.

As of its launch, SRP can currently be used to report safety problems related to foods, animal feed, animal drugs, and adverse events occurring on human gene transfer trials. Trial sponsors can use the portal to prepare a report, print it and send it to the agency to satisfy reporting requirements for investigational new drugs.

The system is planned to eventually encompass other types of clinical trials, and also allow for reporting on safety problems that arise from products regulated by a broad array of federal agencies. The FDA sees this as the first step towards creating a common electronic reporting system that would allow an individual to file a single report to multiple agencies.

The FDA and NIH hope SRP will ultimately enhance the government’s systemic analysis of safety information to greater benefit public health.

Get the latest information on Health IT and attend other valuable sessions at this two-day Summit providing healthcare leaders with educational content, insightful debate and dialogue on the future of healthcare and technology.

Learn More

Topics

News

Study will Leverage Connecticut HIE to Help Prevent Suicides

A new study will aim to leverage CTHealthLink, a physician-led health information exchange (HIE) in Connecticut, to help identify the factors leading to suicide and to ultimately help prevent those deaths.

Duke Health First to Achieve HIMSS Stage 7 Rating in Analytics

North Carolina-based Duke Health has become the first U.S. healthcare institution to be awarded the highest honor for analytic capabilities by HIMSS Analytics.

NIH Releases First Dataset from Adolescent Brain Development Study

The National Institutes of Health (NIH) announced the release of the first dataset from the Adolescent Brain Cognitive Development (ABCD) study, which will enable scientists to conduct research on the many factors that influence brain, cognitive, social, and emotional development.

Boston Children's Accelerates Data-Driven Approach to Clinical Research

In an effort to bring a more data-driven approach to clinical research, Boston Children’s Hospital has joined the TriNetX global health research network.

Paper Records, Films Most Common Type of Healthcare Data Breach, Study Finds

Despite the high level of hospital adoption of electronic health records and federal incentives to do so, paper and films were the most frequent location of breached data in hospitals, according to a recent study.

AHA Appoints Senior Advisor for Cybersecurity and Risk

The American Hospital Association (AHA) has announced that John Riggi has joined the association as senior advisor for cybersecurity and risk.