This on-demand webinar is FREE. This webinar was recorded on September 12, 2019.
FDA discusses trends with the Clinical Data Interchange Standards Consortium - Standard for Exchange Nonclinical Data (CDISC-SEND) data quality issues in sponsor-submitted studies and how industry may resolve them. CDER’s Office of Computational Science (OCS) presents. OCS manages the KickStart Service which provides data quality assessments to pharmacology and toxicology reviewers in the Office of New Drugs (OND).
The webinar covers several examples of substantive data quality issues FDA sees across studies. For example, the Subject Element domain sometimes contains overlapping dates across elements.
- Common data quality and data fitness issues
- Evaluate possible solutions to the data fitness issues presented and provide resources that may be helpful to industry
- FDA communication methods to provide feedback to sponsors about data quality issues
- Overview of the components of the KickStart Service related to data fitness and data exploration
- Regulatory affairs professionals who submit SEND data to FDA for review for:
- Investigational new drug applications (INDs)
- New drug applications (NDAs)
- Certain biologics license applications (BLAs)
- CROs and/or consultants preparing and reviewing SEND datasets for sponsors
- Staff of standards developing organizations responsible for implementation guides for use by the pharmaceutical industries
Program Manager, KickStart Service
Office of Computational Science (OCS) | Office of Translational Sciences (OTS) | CDER | FDA
Contractor – SEND Subject Matter Expert
- has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion.
- is eligible for SOCRA credit in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. Candidate must provide documentation of participation.
- has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- has been approved by ACRP for medical education credits. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
- CME, CPE, CNE will not be provided for this event.
- Guidance: Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act
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