3.1 As the Sponsor, ensure ongoing monitoring investigations: Documentation of safety monitoring plan Document the sponsor's written monitoring procedures Documentation of data monitoring plan and the name and address of any monitor. (812.25) Monitor of study: Select monitors qualified by training and experience. Protocol Director (812.43(d)) Secure Compliance Other: ____________________ (812.46(a)): Secure Investigator compliance with the signed agreement, investigational plan, etc., or terminate All Correspondence with monitor: investigator’s participation and discontinue shipments of the Monitoring log investigational device to the investigator; N/A Require terminated investigator to dispose of or return the device, unless this action would jeopardize the rights, safety, Who will be reviewing safety data: or welfare of a subject. Protocol Director Immediately conduct an evaluation of any unanticipated adverse device effect (UADE). (812.46(b)(1)) DSMB Discontinue investigation within five (5) working days Medical Monitor when the UADE determination identifies unreasonable to Other ____________ subjects and not later than 15 working days after the sponsor first received notice of the effect. (812.46(b)(2)) Obtain IRB and FDA approval before resuming terminated studies. (812.46(c)) FDA Good Clinical Practice Guidance 4.0 Record Keeping (Review sections 8.2 and 8.3: Before and during the Clinical Trial)
3.1 As the Sponsor, ensure ongoing monitoring investigations: Document the sponsor's written monitoring procedures and the name and address of any monitor. (812.25) Select monitors qualified by training and experience. (812.43(d)) Secure Compliance (812.46(a)): Secure Investigator compliance with the signed agreement, investigational plan, etc., or terminate investigator’s participation and discontinue shipments of the investigational device to the investigator; Require terminated investigator to dispose of or return the device, unless this action would jeopardize the rights, safety, or welfare of a subject. Immediately conduct an evaluation of any unanticipated adverse device effect (UADE). (812.46(b)(1)) Discontinue investigation within five (5) working days when the UADE determination identifies unreasonable to subjects and not later than 15 working days after the sponsor first received notice of the effect. (812.46(b)(2)) Obtain IRB and FDA approval before resuming terminated studies. (812.46(c)) Documentation of safety monitoring plan Documentation of data monitoring plan Monitor of study: Protocol Director Other: ____________________ All Correspondence with monitor: Monitoring log N/A Who will be reviewing safety data: Protocol Director DSMB Medical Monitor Other ____________ 4.0 Record Keeping FDA Good Clinical Practice Guidance (Review sections 8.2 and 8.3: Before and during the Clinical Trial)
SIR_IDE_training-checklist.docx