Chapter 10 - Serious Adverse Event (SAE)

1. Investigator Site to Sponsor/CRO; lICH-GCP recommendations: Immediately 2. Investigator Site to Ethics Committee; lICH-GCP recommendations: As per the applicable regulations 3. Sponsor/CRO to Regulatory Agency; lICH-GCP recommendations: a) Fatal or life-threatening unexpected adverse drug reactions- Within 7 calendar days

  Chapter, Site, Events, Serious, Adverse, Investigators, Investigator site, Chapter 10 serious adverse event