Docket Management
Docket: 00N-1484 - Safety Reporting Requirements for Human Drug & Biological Products
Comment Number: EC -11

Accepted - Volume 3

Comment Record
Commentor Dr. James Nickas Date/Time 2003-05-01 18:05:58
Organization Genentech, In
Category Health Professional

Comments for FDA General
1. General Comments COMMENT ON SADR DEFINITION The proposed SADR definition includes events for which a causal/contributory relationship cannot be ruled out. Without additional guidance, the concept of cannot rule out is just as ambiguous as the reasonable possibility concept, which is included in the current IND safety report regulation. The Agency should consider issuing causality attribution guidance such as the one used to identify and define environmentally associated rheumatic disorders (Miller et al. 2000). Miller FW, et al. Approaches for identifying and defining environmentally associated rheumatic disorders. Arthritis & Rheumatism 2000;43:243-49. COMMENT ON INVESTIGATOR REPORTING The proposed rule would require investigators to immediately report any serious SADR, and to promptly report any other SADR to the sponsor. The latter presumably includes non-serious SADRs, which are traditionally recorded on case report forms during the study but are not generally reported to the sponsor expeditiously. Non-serious adverse events recorded on case report forms are generally verified and collected by the sponsor during scheduled monitoring visits. Perhaps the proposed rule should instruct investigators to promptly record rather than report other SADRs.

EC -11