It is important that serious adverse events (SAEs), adverse events (AEs), or other unanticipated problems be reported immediately to both the Trial PI (Nitin Jain) & Trial Coordinator (Helen Koudelková). Information about Serious Adverse Events (SAEs) and Adverse Events (AEs) will be systematically collected via patient questionnaires. However, should study personnel become aware of such events – for example, during a follow-up visit or review of the patient’s medical record – the site coordinator should report the event immediately using the Events instrument in REDCap. Any unexpected problems, such as a data breach or loss of data, should be reported in the same manner. Once reported via REDCap, the trial PI will evaluate the event to determine its severity and relationship to the study and the event will be reported, as appropriate, to the IRB &/or study funder. (Local IRB reporting requirements may also apply.) Treating physicians &/or site personnel may be asked to provide additional information or documentation, as needed.

Serious Adverse Events (SAEs) include:

  • Death
  • Event requiring hospitalization (in-patient admission) related to treatment

Adverse Events (AEs) include:

  • Post-operative infection
  • Post-operative bleeding
  • Nerve injury
  • Blood clot
  • Complications due to anesthesia
  • Adhesive capsulitis (frozen shoulder)

Unanticipated Problems include:

  • Breach of confidentiality
  • Loss of data