Data Requirements for an FDA Submission

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Sunday, September 13, 2020: 8:45 AM - 10:15 AM

SESSION CHAIRS & SPEAKERS

Workshop Instructor
Frederick Wood
Jr., Ph.D, Vice President
Data Standards Consulting Group

SESSION DESCRIPTION 

This masterclass will provide information to those involved in regulatory submissions. It will discuss the regulatory basis for submitting standardized electronic data to the FDA, provide an overview of the Agency’s required data submission standards, and review the documentation needed to support the clinical submission datasets.

Topics will include the following:

  • Regulatory Basis for Standardized Electronic Data
  • FDA Guidance Documents and Technical Specifications
  • The Data Standards

CDISC Overview

The Role of PhUSE  

  • Beyond the Data

aCRF

Define

SDRG

SDSP

Software Programs

  • Traceability
  • The Process
  • Preparing for a Submission


TOPIC


LEARNING OBJECTIVES

- Understand the regulatory basis for the requirement for electronic data and standardized electronic study data
- Become aware of the specific data standards the agency expects
- Recognize that additional documents/files are required to support the submission of study data

SESSION INFORMATION

CDM Certification Competencies::
Electronic Data Collection,Clinical Trials Processes, Roles, and Responsibilities,Protocol Review

Target Audience:
Programmer,CDM Leadership,Regulatory Liaison