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This form is to be completed for any research study targeting or reasonably anticipating enrolling vulnerable individuals
Instruction for submitting this form
you may choose to use this form to report a concern or complaint. you can send us this form in one of the four ways ( recommended you use the fourth way for convenience)
(1) By E-mail:
firstname.lastname@example.org or email@example.com
call and ask for IREC administrator on mobile no. 0787723677.
(3) Send a letter to report your concern or complaint.
mail to the following address and use this form as a guide to include important information.
P.O. Box 3-30100
(4) Fill below and upload the soft copy of the form in the field below
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.
Non-Compliance Reporting Form
this form should only be used to report observated 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 requirejents 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 a multiple studies, complete a form for each study.
2. attach any supporting documentation to the report.