It is important for people involved in clinical research to understand how their work impacts the compilation of an Electronic Submission (ESUB) to U.S food and drug administration (FDA). Here is all about ESub Package for clinical data.
An Introduction to Electronic Submission (ESub) for Clinical Data
People involved in clinical research must be aware of the current FDA guidance pertaining to the electronic submission (ESub) for clinical data. In the past, FDA used to receive NDA in the form of piles and piles of paper. This prompted the FDA to move toward a paperless submission eventually. Since they like to do their own analyses, FDA also requires ESubs to include user-friendly datasets and associated documentation.
The FDA lays great emphasis on performing the analyses themselves as they believe it is needed to demonstrate the drug’s safety and efficacy. For this reason, it requires the people involved in clinical studies to give related datasets and ESub components as much attention as possible. Moreover, the FDA requires them to understand how their work impacts the compilation of an Electronic submission to FDA.
By being informed, you can save time setting up an ESUB. Moreover, you will be able to improve the quality of your datasets and associated documentation, which will aid analysis by the FDA. Ultimately, this will benefit your clinical investigation and its FDA approval.
The Main Purpose of ESUB
The main purpose of the ESub package is moving towards paperless submission, aiding data searching, standardizing what FDA receives from each party, and enabling FDA to quickly understand the data structure and perform their own analyses.
Barring a few select cases, the current guidance for ESub focuses mostly on the content of the dataset documentation rather than dataset structure. However, the latter is being addressed as Clinical Data Interchange Standards Consortium (CDISC) standards are implemented. An ESUB typically has three main components which are as follows:
Text including reports, tables, etc.
Images including scanned CRFs, X-rays, CT-Scan, etc.
Data including datasets, annotated CRF, descriptive documents, etc.
It should be noted that agencies other than the FDA can ask for datasets but most do not. They may have their own guidance on structure and content. FDA guidance is very helpful, but since there is flexibility in it, the exact components should be agreed with the FDA, prior to the submission. This will help ensure that the submission will meet their expectations and that time will not be lost in the creation of wasteful products or the rework.
The FDA Guidelines for Submission
The FDA uses data standards to modernize and streamline the NDA review process. Additionally, it enables a more consistent use of analysis tools to better view drug data and highlight the areas of concern.
Recently, the FDA instituted a new requirement for data standards that applies to most study data submitted to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
The FDA may refuse to receive any Electronic Submission (ESub) whose study data do not conform to the required standards specified in the FDA standards data catalog. Electronic submissions of standardized study data will be required for the following submission types:
Certain investigational new drug applications (INDs)
Abbreviated new drug applications (ANDAs)
Certain biologics license applications (BLAs)
Unless they are exempt from the ESub requirement or unless the FDA grants a waiver, study data that is not submitted electronically will not be filed.
It should be apparent by now that ESUB datasets and documents are as relevant as the study tables for effective submission to the FDA. To this end, guidance is available, which people involved in the clinical process research should be familiar with. Moreover, you should look out for future changes to the specifications. If you want to ensure compliance with FDA’s ESub requirements for clinical research, contact us today.