According to FDA Draft Guidance for Industry in Electronic Submission and Study Data Technical Conformance Guide, the pharmaceutical companies will need to provide CDISC Electronic submission to FDA. The paper will explain Data Standard Catalog which will dictate FDA Standards. The paper will discuss how to prepare CDISC electronic submission and what to prepare in CDISC electronic submission.
I have a son who is 8 years old. Well, he start asking a lot of questions. Like why do I need to clean a play room? Sometimes, those questions are kind of annoying, but if I think about it, I have to agree with my son’s approaches. Whenever we need to do something, we may need to ask “Why”.
One of the most popular TED talk given by Simon Sinek starts with Why. Simon Sinek inspired 17.5 million viewers with “Why” and he also introduced Golden circle. Whenever we need to do something, it starts with Why, How and What.
Our talk today will approaches CDISC electronic submission with Why, How and What.
First, let’s us take a look at current status in electronic submission.
And, if we look at CDISC submission, FDA is also getting more of CDISC data.
The FDA Guidance document, once finalized, will be binding rather than recommendation.
It basically explain how the industry prepares electronic submission.
Module 1 : contains administrative information and prescribing information. It has documents that are specific to each region, such as application forms or the labelling information for use in the region.
Module 2 : contains high-level documents, which summarize the findings from each section of the submission or elements of the drug development process
Module 3 : drug substance(active ingredients) and drug product (active ingredient plus and excipients, such as buffers, fillers and binders, that are used in the making of a pill, capsule, or liquid)
Module 4 : contains animal study reports.
Module 5 : contains clinical study information.
FDA Draft Guidance introduces a very important document. We believe that Data Standard Catalog is the central piece of all FDA standards.
FDA also introduces 4 time tables for standards
This won’t replace the communication between each sponsor and its FDA review division
Study Data Technical Conformance Guide also introduce Study Data Standardization Plan. CSS/PhUSE is currently working on developing Study Data Standardization Plan.
In addition, if we know what we will prepare for final FDA submission, it will help us to prepare all the parts early, rather than modifying them last minutes.