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FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.
FDA has issued a draft guidance relating to electronic submissions. Guidance for Industry: Providing Submissions in Electronic Format—Summary Level Clinical Site Data for CDER’s Inspection Planning is one in a series of guidance documents intended to assist sponsors and applicants making certain regulatory submissions to FDA in electronic format.
The draft guidance describes FDA’s recommendation that applicants submit summary-level clinical-site datasets in a standardized electronic format. This guidance generally applies to submissions of summary-level clinical-site datasets for new drug applications (NDAs), biologics licensing applications (BLAs), and NDA and BLA supplemental applications containing new clinical-study reports that are submitted to FDA’s Center for Drug Evaluation and Research (CDER). The purpose of the guidance is to assist applicants in the submission of a clinical dataset that describes and summarizes the characteristics and outcomes of clinical investigations at the level of the individual study site (summary-level clinical-site data). The summary-level clinical-site dataset is intended to facilitate the use of a risk-based approach for the timely identification of clinical investigator sites for on-site inspection by CDER during the review of marketing applications. The guidance refers to a number of technical specification documents and other resources. These technical specification documents and resources are available online to make them more accessible to applicants.
FDA also issued another draft guidance, Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning, which provides current FDA specifications for preparing and submitting a summary-level clinical-site dataset in electronic form for NDAs, BLAs, and NDA or BLA supplemental applications submitted to FDA’s CDER.