How to Handle Withdrawals Due to Adverse Events in Clinical Trials

Adverse events are natural parts of clinical trials. The nature of the research itself presents risks that may have to be dealt with. Patients involved in research may feel the need to withdraw their own consent if they have an adverse reaction, or the principal investigator may feel the need to withdraw the patients from the study. If this happens, proper protocol and guidelines have to be followed to ensure complete patient protection, respect and privacy.

Instructions

• 1

  Report the adverse event to the principal investigator for review. Then report the A.E. to the investigational review board.

• 2

  Report the adverse event to the study sponsor, who will then report it to the Food and Drug Administration.

• 3

  Withdraw the subject from the study by doing a final checkup with the principal investigator, including blood work and vital signs, to determine the causality relationship of the study drug and the adverse event.

• 4

  Protect patient safety and rights, and continue to follow up with patient for six to 12 months as deemed necessary by the principal investigator.

• 5

  Fill out all necessary patient information in any required databases, and close out the patient from the study.