Adverse Event Documentation: AE Log and GAE Log CRF Completion Training Binder pages 269 - 272. Reportable AEs – Report on AE Log CRF. All genital, genitourinary, and reproductive system AEs except Fetal losses All Grade 2 and higher AEs All SAEs
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Any AE not covered above will go on a
Grade 1 AE Log CRF
Specify exact anatomical location of the pain
AE clarification; product hold clarification
AE text is …
Relations Completionhip to Study Product (Item 4)