No Yes: Please explain how and append appropriate documents: Note: If the consent requires revisions, no new participants may be enrolled until the revised consent form has been approved. Have you complied with all applicable reporting requirements? (e.g., of the Sponsor and/or FDA) Yes No Not applicable Status of research activities. Please check all that apply: No change in research activities All research activities have been temporarily and voluntarily stopped for all subjects Partial voluntary hold on some research activities for all subjects (please detail below) Voluntary hold on new subject enrollment only Corrective action plan, including plan to prevent recurrence, if applicable: By submitting this form the Principal Investigator certifies that: All necessary information has been assessed and is completed in sufficient detail to facilitate IRB review. The risks of the research are minimized to the greatest extent possible. The risk-benefit relationship of the research continues to be acceptable. The consent form does not require revision. The consent form requires revision. A tracked changes copy and a clean copy of the revised consent are attached. -------------------------------------------------------------------------------------------------------------------------------
No Yes: Please explain how and append appropriate documents: Note: If the consent requires revisions, no new participants may be enrolled until the revised consent form has been approved. Have you complied with all applicable reporting requirements? (e.g., of the Sponsor and/or FDA) Yes No Not applicable Status of research activities. Please check all that apply: No change in research activities All research activities have been temporarily and voluntarily stopped for all subjects Partial voluntary hold on some research activities for all subjects (please detail below) Voluntary hold on new subject enrollment only Corrective action plan, including plan to prevent recurrence, if applicable: By submitting this form the Principal Investigator certifies that: All necessary information has been assessed and is completed in sufficient detail to facilitate IRB review. The risks of the research are minimized to the greatest extent possible. The risk-benefit relationship of the research continues to be acceptable. The consent form does not require revision. The consent form requires revision. A tracked changes copy and a clean copy of the revised consent are attached. -------------------------------------------------------------------------------------------------------------------------------
SeriousUnanticipatedProblemSeriousUnanticipatedAdverseEventReportForm.docx