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Traditional Chinese Herbal Medicine (TCHM)

Mild Adverse Event (AE) Database Reporting Tool

Reporting Information

AE definitions according to: Dietary Supplement and Non-prescription Drug Consumer Protection Act PUBLIC LAW 109–462—DEC. 22, 2006

SERIOUS ADVERSE EVENT

The term ‘serious adverse event’ is an adverse event that:
—‘‘(A) results in—

  1. death;
  2. a life-threatening experience;
  3. inpatient hospitalization;
  4. a persistent or significant disability or incapacity; or
  5. a congenital anomaly or birth defect; or

—‘‘(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).

STOP and click here to report to FDA!

ADVERSE EVENT

.—The term ‘adverse event’ means any health-related event associated with the use of a nonprescription drug that is adverse, including—

  1. death;
  2. a life-threatening experience;
  3. inpatient hospitalization;
  4. a persistent or significant disability or incapacity; or
  5. a congenital anomaly or birth defect; or

To report use the form on the right

Mild AE Report Form

This NON FDA reportable mild Adverse Events (AE) – reporting tool is intended for interprofessional data collection purposes.

Traditional Herbal Medicine Adverse Event related to:(Required)
3. Patient gender(Required)
5. Race(Required)
7. (AE) reported(Required)
14. Product acquisition source(Required)
21. Form of the preparation(Required)
I hereby agree that data entered will be stored electronically, and will be processed and used for reference and research purposes.(Required)
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