Chapter 5 Project Appraisal and Risk
Jul 17, 2015 · abnormal lab values. Please refer to Tables 4, 5, and . 6. in Appendix A for suggested formats for data collection and reporting. F. SAE Reporting. Unexpected, serious, and intervention-related SAEs must be reported to the Independent Monitor, IRB, GCRC / CTSA, NCCIH, and other oversight organizations as appropriate. The SAE reporting plan ... ................
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