NTU-IRB requires PIs to report any incident arising from (a) Protocol Deviation/Non-Compliance, (b) Unanticipated Problem and/or (c) Serious Adverse Events using the Incident Report Form.
All Serious Adverse Events that occur during the course of an approved research study needs to be immediately reported to NTU-IRB.
The categories of incidents to be reported are defined as follow:
- Protocol Deviation/Non-compliance
- Changes or departures from the study design/procedures of a research project that are deemed to be under the PI's control but have not been reviewed and approved by the IRB.Such deviations/non-compliance, whether major or minor, are reportable incidents
- Unanticipated Problem
- A harm that is "not anticipated" when its specificity and/or severity is inconsistent with the risk information (in terms of nature, severity, frequency, and characteristics of the study population) previously reviewed and approved by the IRB.
- Examples of unanticipated problems include breach of confidentiality, complications arising from the use of medical devices and Unanticipated Problems involving Risks to participants or others (UPR).
- Even if actual harm does not occur, incidents meeting the above definition must be reported to NTU-IRB through the Incident Report Form.
- Serious Adverse Events
- Any adverse event associated with the research subject's participation in research that results in any of the following:
- is life-threatening (places the research subject at immediate risk of death from the event as it occurred)
- requires inpatient hospitalization or prolongation of existing hospitalization
- results in a persistent or significant disability/incapacity
- results in or contributes to congenital anomaly/birth defects
- results in the transmission of a communicable disease
- results in any misidentification or mix-up of any type of tissue, gametes or embryo (in relation to any tissue banking activity); or
- any other adverse event that, based upon appropriate medical judgment, may jeopardize the research subject's health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. Examples of such events include allergic bronchospasm requiring intensive treatment in the emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
- In accordance with Section 23(3)(b) of the HBRA, PI must inform NTU-IRB immediately of any Unexpected Serious Adverse Event.
- For events that involve death or is life threatening, NTU is required to submit all relevant documentation to Director, MOH within 7 days after knowledge of the event. Additional relevant information has to be submitted to MOH within 8 days of recording of such information.
- For events that do not involve death or is not life-threatening, NTU is required to submit relevant information to MOH within 15 days after knowledge of the event.
- Please refer to MOH's infographics on reporting SAE here.
PI must submit the completed Incident Form to firstname.lastname@example.org. NTU-IRB Secretariat will notify the PI of the outcome of the review. For more information, please send your queries to email@example.com.