Online Safety Community

The FDA’s Adverse Event Reporting Requirements

The FDA's Adverse Event Reporting Requirements5.jpg

The adverse event reporting system is an important highlight of the FDA’s adverse event reporting requirements. This is the mechanism through which adverse event reporting requirements are listed out for the FDA to take further action.

The adverse event reporting system may be understood as being a database that aids and supplements the FDA’s postmarketing surveillance program for all its approved products that fall in the category of therapeutic biologics and drugs. So, this database has a record of the adverse event reporting done by all individual and sponsors of their clinical trials. It is a catalog of all the error reports that get generated at various times and stages of the clinical research program.

Voluntary in nature

The FDA's Adverse Event Reporting Requirements4

The outstanding aspect of the FDA’s adverse event reporting requirements is that these reporting requirements are not mandatory. Yet, those involved in clinical research, such as sponsors, healthcare and pharmaceutical organizations, institutions and individuals strictly adhere to adverse event reporting requirements in order to steer clear of legal entanglements that could come their way in the future, and to help other players keep track of all adverse events.

Some of the core adverse event reporting requirements

The FDA's Adverse Event Reporting Requirements1

Applicants should electronically submit all Individual Case Safety Reports (ICSRs) for human drug and nonvaccine biologic products in xml format. Among the adverse event reporting requirements, this has been in place from 2000.

The FDA has been amending rules relating to adverse event reporting requirements from time to time. According to the amendment passed in June 2015; the following adverse event reporting requirements apply:

All applicants should submit all ICSRs, ICSR attachments, and periodic safety reports electronically. They can do this using either of these options:

The E2B method specifies that the files should be in xml format, and the attachments in pdf.

The FDA's Adverse Event Reporting Requirements3

The Safety Reporting Portal (SRP) is meant for those applicants that do not have the database-to-database capability. To fulfill this among the FDA’s adverse event reporting requirements, the applicant needs to have an account with which to access the portal site. FDA’s adverse event reporting requirements state modes and criteria that applicants have to meet to request an SRP account, to activate the account, to add attachments, and for submitting Periodic Safety Reports (PSR).

click to continue reading

Views: 24

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Jam Blanco posted a blog post

Making Temporary Construction Fencing Panels

Fencing at construction sites is necessary since it keeps both workers and the general public safe from mishaps on site. If there aren’t any clear boundaries marking off a zone, anyone can wander in and get seriously hurt. With the right precautions in place you can avoid costly lawsuits, fines, deaths and stress.…See More
13 hours ago
John Robinson posted events
17 hours ago
Training Doyens posted events
19 hours ago
swetha posted a blog post

Nebosh IGC Training course - Chennai

Nebosh course in Chennai can be obtained by the safety individual who is doing work, fresher or any engaged indiviuals. The Nebosh course period is 18 days. As we are offering both class room teaching as well as e-learning training with comprehensive of book resources. If you want to perceive a profession in Health and safety sector GWG will give you a best Nebosh training in Chennani.We are…See More
yesterday

Forum

Python Condition Objects Tutorial in 2018

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

Tags: course, certification, training, languages, programming

Started by Elena Lauren Apr 2.

Automation Anywhere. How do I pick a value from dropdown 1 Reply

Automation Anywhere. How do I pick a value from dropdown. I tried 'set text' from a copied variable. Its very slow, and also doesnt…Continue

Tags: anywhere, automation

Started by emmablisa. Last reply by venkatesh Mar 29.

Agile overcome common software security challenges

Paradoxically, security is a negative goal. To secure something, you must understand how insecure it is. Start by trying to break it or by figuring out how other people might break it. The same is…Continue

Tags: agile, scrum, security

Started by nicolewells Mar 23.

Understanding Data Parallelism in MapReduce

In order to understand the goals of MapReduce, it is important to realize for which scenarios MapReduce is optimized. The MapReduce programming model is created for processing data which requires…Continue

Tags: program, Implementation, Mapreduce

Started by gracylayla Mar 14.

TensorFlow serving vs TensorFlow service

I have a question regarding the difference between TensorFlow Serving versus TensorFlow service. (Sorry that I'm not familiar with this at all.)I found TensorFlow serving's definition, which is "…Continue

Tags: training, online, tensorflow

Started by emmablisa Feb 27.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service