Overview

Study data is information about a person in a clinical trial. It includes demographic information, details of the medical treatment, descriptions of the participant’s progress, and other relevant information. If the same attribute information is captured for animals, it is considered non-clinical data. To exchange clinical and non-clinical research data among computer systems, studies suggest certain standard methods are ideal. The United States Food and Drug Administration (FDA) may refuse to file New Drug Applications (NDA) or Biological License Applications (BLAs) and may refuse to receive Abbreviated New Drug Application (ANDA) if the study data submitted to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) is not on par with the data standards. As part of a collaborative effort between the FDA and the nonprofit Clinical Data Interchange Standards Consortium (CDISC), the following study data standards have been developed for effective legacy conversions:

• CDISC Standard for Exchange of Nonclinical Data (SEND) for nonclinical data
• CDISC Study Data Tabulation Model (SDTM) for clinical data
• CDISC Analysis Data Model (ADaM) for analysis of clinical data
• CDISC Case Report Tabulation Data Definition Specification (Define-XML) for the metadata that accompanies SEND, SDTM, and ADaM datasets
• FDA is supporting efforts to develop clinical terminology standards for therapeutic areas within the SDTM
• SDTM will be updated periodically to include new and revised standards for specific therapeutic areas

For effective legacy conversions and study data analysis, Freyr helps organizations navigate end-to-end publishing and submissions.