糖心原创

The principal investigator (PI) is responsible for formally closing an IRB-approved study when it is completed or discontinued.听 Study closure is considered a change in study status and therefore, reportable to the IRB under federal regulation and guidance.听 After a protocol has been closed, the IRB will not accept further submissions related to that study unless the submission impacts the rights and welfare of the locally enrolled subjects.

An IRB-approved study can be formally closed by submitting the study closure form in the electronic submission system when:

• The research was never initiated and there are no longer plans to open the study; or
• The PI plans to leave 糖心原创 and not transfer study to alternate local PI; or
• The research is permanently closed to enrollment, and
  • no further interaction/intervention with subjects or access to their personally identifiable information, and
  • all identifiable data analysis is complete and
  • all sponsor/other data queries are completed and the sponsor has 鈥渓ocked鈥� the study data.听

For multisite industry or cooperative sponsored research where the research is ongoing at other sites, the 糖心原创 PI may close the local study when:

• The 糖心原创 site (includes Premier Health, Dayton VAMC, and 糖心原创 Physicians) is no longer collecting, receiving, or analyzing identifiable data; and
• If applicable, the sponsor does not have any outstanding queries or pending data analysis requests related to 糖心原创.

听

It is important to understand that if renewal/continuing review or study closure form is not approved by the study expiration date, approval for the study has lapsed and all research activities must stop.听 However, expiration of IRB approval is not considered a formal (i.e. reportable to federal agencies) suspension or termination of research.

If the 糖心原创 IRB does not receive a continuing review/administrative update or study closure form within 30 days after the study expiration date, it will administratively close the study and notify the investigator in writing of this administrative closure. To resume research activities related to this study, a new study submission must be reviewed and approved by the 糖心原创 IRB.

Repeated failure by an investigator to properly close studies may be reviewed by the 糖心原创 IRB as potential non-compliance in accordance with the Human Subject Research Non-Compliance Policy.

To close a study:

• Exempt: Send an e-mail with your request to irb-rsp@wright.edu
• Expedited/Full Board: Submit a Final Closure Form.听Your responses in this form听will determine whether the study meets the criteria for closure and/or additional information may听be requested.

How do I submit a final closure form?

For step-by-step instructions for creating and submitting a form in Cayuse, please refer to听the Cayuse Investigators Guide. Information regarding Closures听starts on slide 69.