FDA's December 2012 Guidance On IND And BA/BE Reporting - Part III

By Bart Cobert

Continuing with the review of the key points in FDA’s guidance. This is the final part.

Aggregate Reports of SAEs as a 15 Day IND Safety Report

FDA discusses this in detail.

An IND safety report based on aggregate data must be in narrative format and must include a description of the suspected AR, all relevant information e.g. summary information about symptoms, concomitant medications, demographics, comorbid conditions, past history, pertinent laboratory test results, timing of events (onset and duration), and duration of treatment. Data from previously submitted individual case IND safety reports should be included, if applicable.

Finally, the narrative report should describe the characteristics and results of the analysis, including a description of the databases, how the conclusion was reached, who reviewed the analysis, any planned changes in monitoring or to study documents (e.g., informed consent, IB), and any planned further analyses.  Individual cases described in the submission must also be included as 3500A forms.  If some individual cases were previously submitted as IND safety reports, they should be resubmitted and clearly identified as duplicates. Before submission, each individual case report should generally be unblinded.

The sponsor should determine an appropriate approach for reporting subsequent occurrences of the same event to FDA and all participating investigators, and the sponsor should include a description of this approach in the initial expedited narrative IND safety report.