FDA, NIH collaborate on AE reporting

Share this article:

The FDA and the NIH have agreed to develop a harmonized adverse event (AE) reporting mechanism for consumers, health professionals, investigators, sponsors and other parties to electronically submit reports.

The project is aimed at developing a “Rational Questionnaire” and electronic prototype system for reporting. The questionnaire is intended to be an “interactive help system” that will assist AE reporters in determining which data need to be submitted and to whom. The prototype system will allow the agencies to test the feasibility of a central, federal web-based portal to provide direct, seamless, online submission of adverse event reports to appropriate agencies.

A harmonized reporting system would reduce the amount of reporting by clinical investigators, according to the MOU. Currently investigators must submit separate AE reports to multiple agencies using different forms.

“Oversight bodies and agencies receiving this information are often faced with tremendous volumes of data reported in idiosyncratic ways, which often frustrates efforts to conduct meaningful aggregations and analyses of data, or to cull from reports information key to important safety concerns,” the MOU explains.

A joint Federal Adverse Event Task Force has been formed and they are tasked with developing a consensus standard for adverse event reporting called the Basal Adverse Event Report. 
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete October 2014 Digital Edition

Read the complete October 2014 Digital Edition

Click the above link to access the complete Digital Edition of the October 2014 issue of MM&M, with all text, charts and pictures.

Predicting your pink slip

Predicting your pink slip

Any time a firm needs to save money, high-salaried executives are targets

Private View: New ways to engage with customers

Private View: New ways to engage with customers

These healthcare social media campaigns successfully use emotion, altruism and the human desire to "brand" oneself to get customers engaged.