CDISC established standards to support the acquisition, exchange, submission and archive of nonclinical and clinical data.Since its formation in 1997, the CDISC mission is “to develop and support global, platform-independent data standards that enable information system interoperability, to improve medical research, and related areas of health care.” CDISC provides data standards for the entire clinical trial process, from source to analysis/reporting and culminating in regulatory submission.This includes standards for Trial Design and Protocol Information, CRF and Subject Data, Analysis Datasets and Regulatory Submissions.
The FDA mandate for using the CDISC SEND format for nonclinical data, depends on when a study commenced, and the type of submission.
The SEND format, which goes into effect for studies started on or after December 18, 2016, is required for data contained in New Drug Applications (NDA), abbreviated new drug applications (ANDA), and certain biologics license applications (BLA).
Detailed information on study and submission guidelines for the FDA, EMA and PMDA can be reviewed at CDISC and regulatory agency websites.
What are the consequences for not following CDISC electronic data submission guidelines?
Towards the end of 2016, the US Food and Drug Administration (FDA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA), will require electronic submissions of certain nonclinical data using the CDISC SEND standard format.
Other regulatory agencies, including the European Medical Agency (EMA), Korean Ministry of Food and Drug Safety, and China Food and Drug Administration, are also considering the use of CDISC standards.In this blog post, I’ll discuss how the move towards using CDISC standards will facilitate review of datasets in a standard format between sponsors and CROs and standardize submission of nonclinical data to the FDA and other regulatory agencies.I’ll also mention some solutions for streamlining data preparation for CDISC-ready submissions. The Clinical Data Exchange Standards Consortium (CDISC) is a global, multidisciplinary, non-profit organization.Submissions that do not comply with CDISC requirements could receive a Refuse to File (RTF) for NDAs and BLAs, or Refuse to Receive (RTR) for ANDAs from the FDA.Furthermore, retroactively standardizing data can be a very complex and daunting task.Although these requirements will not impact IND submittals until December 2017, the FDA Center for Drug Evaluation and Research (CDER) strongly encourages companies to consider the implementation and use of data standards for the submission of applications.