Common use of Reporting Instructions Clause in Contracts

Reporting Instructions. All SAEs and other events requiring expedited reporting must be reported using B-001 SAE CRF and submitted to DSSM within 24 hours of the study site personnel's initial notification of the event. • When reporting potential Hy's Law cases, the SAE CRF should include the following: - Seriousness Criteria = Important Medical Event - Assessment/Narrative: Include the term “Potential Hy’s Law case” in the narrative; the text should also detail what additional study results are available at the time of reporting and what other studies are planned or results pending to further investigate alternative causes of the abnormal ALT/AST or bilirubin that triggered the report. The timing of planned patient follow-up should also be noted. See Section 8.4. • NSABP will forward expedited report forms that meet reporting requirements concurrently to the FDA and to Merck and Antigen Express pharmacovigilance divisions with the causality assessment. • Investigators are responsible for reporting AEs that meet specific criteria to their local IRBs.