The US Food and Drug Administration (FDA) has circulated draft guidelines to the life sciences industry on the requirements about the submissions in Electronic Format for Clinical Site Data by the Centre for Drug Evaluation and Research (CDER) Inspection Planning. Now the regulatory authority is seeking comments from the industry on the guidance before February 2013.
CDER’s inspection planning includes selection of clinical investigator sites for on-site inspections. To facilitate timely selection of inspection sites, the Centre must have sufficient data from the sponsor to identify which sites will provide the necessary information for the review of the application.
The regulatory authority recommends that applicants submit summary level clinical site datasets in a standardized electronic format. The guidance applies to submissions of summary level clinical site datasets within new drug applications (NDAs) and biologics licensing applications (BLAs). It also details on the NDA and BLA supplemental applications containing new clinical study reports that are submitted to CDER.
The purpose of the guidance is to assist applicants in the submission of a clinical dataset that summarizes the characteristics and outcomes of clinical investigations at the level of the individual study site.
The summary level clinical site dataset is intended to facilitate 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 also refers to a number of technical specification documents and other resources which are available online to make them more accessible to applicants.
Since the reliability of clinical trial data is critical to the approval decision, all CDER review disciplines share responsibility for evaluating data integrity. CDER’s Office of Scientific Investigations (OSI) has specific onus to verify the integrity of data submitted to CDER in support of new applications and supplements. It would also determine whether clinical trials are conducted in compliance with applicable FDA regulations and statutory requirements, including human research subjects, said the regulatory authority.
Clinical data is a central component of most NDAs and BLAs submitted to CDER. As part of the review process, CDER may conduct on-site inspections of clinical investigators, sponsors/applicants, contract research organisations, and institutional review boards involved in clinical trials that were submitted in support of applications for product approval. During these inspections, FDA field investigators are authorised to obtain, copy, and verify records for FDA regulated clinical trials with regard to subject case histories, and to review the storage and disposition of the investigational product under 21 CFR parts 312 and ensure that clinical data are maintained, tabulated, and submitted under the regulations provided in 21 CFR part 314.
To meet its review performance goals in accordance with CDER good review management principles and practices for products covered by the Prescription Drug User Fee Act (PDUFA), CDER must initiate inspection planning early in the application review process.
A summary level clinical site dataset contains studies that support various treatment indications. The key objective is to characterize individual clinical investigator sites. It should describe aspects of the studies with which those clinical investigator sites are associated. It also provides critical information in a usable format to assist in site selection.