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CHECKLIST FORM
This is a list of the items required, tasks to be performed, or things that need to be considered.
PROMPT REPORTING FORM
This form should only be used to report unanticipated problems involving risks to subjects or others (hereafter known as unanticipated problems) and investigator- or sponsor-initiated study suspensions or holds. Do not use this form to report non-compliance.
VULNERABLE POPULATION FORM
This form is to be completed for any research study targeting or reasonably anticipating enrolling vulnerable individuals
NON-COMPLIANCE REPORTING FORM
This form should only be used to report observed or apparent noncompliance. Noncompliance is defined as any action or activity associated with the conduct or oversight of research involving human participants that fails to comply with research regulations, or institutional policies governing human participants research or the requirements or determination of the IREC committee. if you need to report a major protocol deviation, please use the prompt reporting form
1. If this report applies to multiple studies, complete a form for each study.
2. Attach any supporting documentation to the report.
COMPLIMENT AND COMPLAINT FORM
As part of monitoring our processes, IREC would like to hear from you. This form will help us know our weaknesses and our strengths and provide ground for opportunities for improvements.
Once filled, kindly send it back to our email: irec@mtrh.go.ke.