Organization of Clinical Datasets in eCTD Submissions

Electronic datasets have been required with New Drug Applications (NDA) and Biologic License Applications (BLA) since 1999. The guidance documents that describe the organization of electronic datasets in electronic submissions have been withdrawn. Since January 1, 2008, US FDA has required electronic submissions in the eCTD format, which changes the location of electronic datasets. This presentation will review the documentation requirements, the electronic navigation aids required for all the components of the electronic datasets package for a clinical study. Emphasis will be placed on best practices for assuring the datasets package is received in submission-ready format from internal and external biostatisticians. It will also discuss the impact of CDISC on the future of electronic datasets.

Areas Covered in the seminar:

• What are the requirements for electronic datasets in eCTD submissions?
• Where are the contents of clinical datasets located in the eCTD structure for: tabulation datasets, analysis-ready datasets and programs, and patient profiles?
• What approaches should be taken to assure submission-readiness of datasets?
• How can the datasets package be remediate for submission if the deliverables are not submission-ready?
• What is the impact of CDISC and what steps should be taken now to assure compliance with CDISC requirements?
• What steps should be taken if electronic datasets are not available?

Who Will Benefit:

This webinar will provide valuable assistance to all pharmaceutical and biotechnology that are conducting clinical studies with the intent of filing Investigational New Drug (IND) and New Drug Applications (NDA) or Biological License Applications (BLA) submissions. The employees who will benefit include:

• Regulatory affairs
• Clinical operations
• Clinical data management
• Biostatistics
• Information technology managers and personnel
• Anyone specifying deliverables for CROs, writing RFPs, and negotiating contracts for deliverables from clinical trials

Instructor Profile:

Antoinette Azevedo, founded e-SubmissionsSolutions.com (a California corporation) to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Ms. Azevedo’s clients range from large, international pharmaceutical companies to small, virtual biotechnology companies -- all attempting to be better prepared to manage controlled documents and produce electronic INDs and drug/biologic registrations.

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