糖心原创

In Cayuse, investigators can choose from three different new submission forms.聽 Please review the information about each form below, as well as the allowable sub-forms for that type of new submission:

Initial Application Form

Investigators should select and complete this form for:

• New Non-Exempt Human Subject Research Studies (includes collaborative research requests for 糖心原创 IRB to act as reviewing IRB for external investigators/entity working with 糖心原创 investigators on a single project).
• New Exempt Human Subject Research Studies
• New Not Human Subject Research Studies to Receive NHSR Determination Letter

Once your submission has received an initial determination (i.e., approved, exempt, or NHSR), you will have access to add and submit the following sub-forms as needed/required during the conduct of your study:

• Amendment Form 鈥� This form is to request IRB approval for changes to the study.
• Reportable Event Form 鈥� This form is to report problems or events that occur during the conduct of the study that must be reported within 10 calendar days to the IRB, see Reportable Events page for more information.
• Continuing Review/Administrative Update Form 鈥� This form is to provide a status report to the IRB Office to renew the approval or exemption period.聽 See Continuing Review page for more information.
• Miscellaneous Submission Form 鈥� This form is to submit IND safety reports or other documents that do not required IRB review and approval per IRB policy, but for which the sponsor or other entity has requested submission and acknowledgement by the IRB. The IRB Office reviews these submissions and provides the PI with an acknowledgement letter.
• Study Closure Form 鈥� This form is to request that study closure be reviewed and approved by the IRB.

HUD Initial Submission Form

Per Food and Drug Administration (FDA) regulations, prospective IRB review and approval is required to use a specific Humanitarian Use Devices (HUD) in patients even though HUD use is not considered to be 鈥渉uman subject research.鈥澛� Physician investigators who need approval to use a specific HUD must complete and submit this form to the IRB.

Once your HUD submission has received an initial IRB approval, you will have access to add and submit the following sub-forms as needed/required during the conduct of your study:

• Amendment Form 鈥� This form is to request IRB approval for changes to the HUD application.
• Reportable Event Form 鈥� This form is to report problems or events that occur during the conduct of the study that must be reported within 10 calendar days to the IRB, see Reportable Events page for more information.
• HUD Continuing Review Form 鈥� This form is to provide a status report to the IRB Office to renew HUD approval at least annually.
• Study Closure Form 鈥� This form is to request closure of HUD approval as no additional use of the HUD device will be conducted under that investigator鈥檚 IRB approval.

For more information about local requirements to use HUDs, please review the Humanitarian Use Device Policy.

External Reliance Registration Form

Investigators should select and complete this form when requesting 糖心原创鈥檚 permission to rely on an external IRB for review and approval of 糖心原创 research instead of the 糖心原创 IRB.聽 When 糖心原创 cedes IRB review to another entity, it is still responsible for ensuring that:

• An executed Reliance agreement is in place between the two institutions before the research is IRB approved.
• All 糖心原创 investigators have completed all required training and credentialing requirements to conduct human subject research.
• All related ancillary reviews (e.g., Biosafety, Medicare coverage, Nursing) have been completed.
• Sufficient information is provided to facilitate post-approval monitoring by 糖心原创 during the conduct of the research.

External Reliance submissions are reviewed and approved by the Director of the HRPP and/or the 糖心原创 Institutional Official, not the 糖心原创 IRB, to ensure that the above requirements are met prior to 糖心原创 investigators engaging in the research study.

Once your External Reliance submission has received initial approval, you will have access to add and submit the following sub-forms as needed/required during the conduct of your study:

• Amendment Form 鈥� This form is to request IRB approval for changes to the study. For external reliance submissions this is limited to 糖心原创 personnel changes and informed consent revisions.
• Reportable Event Form 鈥� This form is to report problems or events that occur during the conduct of the study that must be reported within 10 calendar days to the IRB, see Reportable Events page for more information.聽
• ER Continuing Approval Form 鈥� This form is to provide a status report to the IRB Office to renew the reliance approval period.聽 See Collaborative Research page for more information.
• Study Closure Form 鈥� This form is to request that local study closure be reviewed and approved once all local research interventions/interactions or analysis of identifiable data has been completed.