Investigator responsibility will not end after approval letter was obtained, the responsibility continues beyond the study completion. Below are different reports under investigator responsibility:
Process of requesting of review for ethics approval extension. Ethics approval by IREC only valid for one (1) year, therefore investigator need to submit request for continuing review. Investigator are required to submit Continuing Review form one (1) month before the current approval expiry. Continuing Review will take about twenty (20) working days or up to sixty (60) working days if a full-board review is required.
Process of requesting amendment/modification/changes on study document after ethics approval was obtained. Investigator are required to submit Amendment form together with every amended document requested. Amendment will take about twenty (20) working days or up to sixty (60) working days if a full-board review is required.
End of study reporting
Process of informing the completion of study and updates the summary on ethical aspect of the study to IREC. IREC will close the file and archive it if the report was satisfactory. Investigator are required to submit End of Study Report form together with study abstract/summary to IREC after the completion of the study. Review and decision on closing of file shall take 10 working days or up to sixty (60) working days if a full-board review is required.
Any departure from the study procedures or treatment plans as specified in the IREC-approved protocol. Protocol deviations occur when an investigator does not implement or follow some aspect of a research study as approved by the IREC. Protocol Deviation:
Any change, divergence, or departure from the research protocol that has not been approved by the IRB (Institutional Review Board) and that DOES NOT have a major impact on the participant’s rights, safety, or well-being or on the completeness, accuracy, and reliability of the research project data. (Examples include but are not limited to study procedure or participant visit conducted out of period, or blood samples obtained at times close to but not at the time specified in the IRB (Institutional Review Board) approved protocol, or having participants sign a non-stamped consent document, not providing the participant with copies of the consent documents.)This information should be provided by the Investigator in Continuing Review form or End of Study report whichever necessary. Decision and action will take up to ten (10) working days after the IREC meeting.
Investigator must report to IREC within five (5) working days using Protocol Deviation Form. Decision and action will take twenty (20) working days or up to sixty (60) working days if a full-board review is required. List of Major Protocol Deviation, read more………….
Serious Adverse Event
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
- All internal SAEs (occurring in IIUM PI site) must be reported to the IREC within 72 hours (about 3 days) of occurrence using SAE Reporting form
- External SAEs (occurring in participants at other sites) must be reported in a prompt manner if the information impacts the continued ethical acceptability of the trial. This includes cases where the information requires, or indicates the need for, a change in the trial protocol or information statement, including changed monitoring
- All other external SAEs (Overseas) (that do not fit the above criteria) need only be submitted if they are suspected and unexpected (i.e., SUSARs) and may be submitted as a periodic listing. A periodic listing of SUSARs must be submitted at least six months
Decision and advice will be communicated about ten (10) workings days after IREC Meeting.
Link to submit Post-Approval submission related form. Kindly download the form, complete it and upload here: