Investigational Product Safety Notifications Flowchart

This diagram illustrates how adverse events and reactions occurring during clinical trials should be reported and evaluated:

1. Safety Assessment: The safety of the research product is evaluated.

2. Causality Assessment: Determine the causality relationship: related or unrelated.

3. Adverse Event/Reaction Decision: Decide whether it is an adverse event or reaction.

4. Severity Assessment: Evaluate the severity: serious or not serious.

5. Serious Adverse Event/Reaction (SAE/SAR): If serious, check whether SAE/SAR needs to be reported.

   The investigator reports the SAE/SAR to the sponsor within 24 hours.

6. Causality and Relationship Evaluation: The sponsor keeps records and monitors until the medical condition returns to normal.

   Assess whether it is related to the research product.

7. Expected and Unexpected Serious Adverse Reactions: Classify as expected SAR or unexpected SAR.

   Evaluate and report Suspected Unexpected Serious Adverse Reactions (SUSAR) to the relevant authorities.