Adverse Event Report

REC-H must be notified of any injury, adverse event, or detrimental incident experienced by a research participant/researcher or co-worker/non-participant that is/may be related to the research procedures. Any undesirable experience or response is considered an adverse event. The adverse event may be physical, emotional, psychological or physiological in nature. It does not necessarily have a causal relationship with the research, or any risk associated with the research.

Researchers are expected to respond to the adverse event immediately.

The Primary Responsible Person is responsible for reporting any adverse event(s) experienced by a research participant / researcher / non-participant that is/may be related to the research procedures.

The Primary Responsible Person must notify the Research Ethics Committee (Human) about the occurrence of the adverse event as soon as possible, but not later than one business day following the event.
 

Adverse event report (for studies approved on MEOS - the Mandela Ethics Online System))

Adverse event reports for studies granted original ethics approval via MEOS must be submitted on MEOS no later than one-business day following the event. 

  1. Refer to the MEOS Applicant User Guide (ver 1.5, updated 19 Jun '23) for details on creating a sub-form.
  2. Log into MEOS using your Nelson Mandela University username and password.
  3. Click on the project for which an extension is required.
  4. Click the [Create Sub Form] button in the left-hand panel.
  5. Select REC-H: Adverse Event Report and click [Create]. 
  6. Students are advised to share the form with their supervisors.
  7. Complete the form.
  8. Sign the form.
  9. Request the signature of the PRP (Primary Responsible Person).
  10. Once signed by all relevant parties, the form will be automatically submitted for review.

MEOS Applicant User Guides:

Adverse event report (for studies approved using the current offline process)

  1. Download the RECH-007 (Adverse Event Report) template.
  2. Researchers are required to familiarise themselves with the instructions provided on page 1 of the form.
  3. Complete the form in full.  Provide suitable responses to each item on the form. 
  4. The completed report, original signed approval letter and original approved application must be submitted to Mr Imtiaz Khan.