Institutional Review Board (IRB)
Request for Continuing Review or Closure

100% of survey complete.

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* 1. Researcher Name

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* 2. Email Address

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* 3. Study Title

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* 4. Expiration Date of Study Approval

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* 5. What is the status of your project? Select either active, or closed and the secondary option that fits best.

Study Active

----No enrollment to date

----Participant enrollment has begun

--- Long term follow-up of subjects

----Data analysis only

Study Closed

----Study was never initiated/no study participants were ever enrolled/study was never funded

----Study has been discontinued and there will be no further data collection or analysis of data

----Sponsor is discontinuing the study

----Principal Investigator is leaving the college/university

----Study is complete, all enrollment, treatment, follow-up and data analysis are completed

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* 6. Since the last IRB review, have any serious, unexpected adverse events occurred that were considered related to participation in the research that have not been previously reported to the IRB?

Yes (please explain)

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* 7. Since the last IRB review, have any protocol deviations/violations involving risks to subjects or others occurred that have not been previously reported to the IRB?

Yes (please explain)

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* 8. Since the last IRB review, have any subjects or others complained about the research?

Yes (please explain)

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* 9. Since the last IRB review, have the risks to subjects changed?

Yes (please explain)

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* 10. Since the last IRB review, has the magnitude of benefit to subjects changed?

Yes (please explain)

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* 11. Do the risks to subjects continue to be reasonable in relation to anticipated benefits, if any, to subjects and to the importance of the knowledge that may reasonably be expected to result?

Yes

No (please explain)

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* 12. Are any changes to the research being proposed at this time?
*Note: The IRB must approve all changes to protocols and consent forms and other study documents prior to implementation.

Yes (please explain)

Question Title

* 1. Researcher Name

Question Title

* 2. Email Address

Question Title

* 3. Study Title

Question Title

* 4. Expiration Date of Study Approval

Question Title

* 5. What is the status of your project? Select either active, or closed and the secondary option that fits best.

Question Title

* 6. Since the last IRB review, have any serious, unexpected adverse events occurred that were considered related to participation in the research that have not been previously reported to the IRB?

Question Title

* 7. Since the last IRB review, have any protocol deviations/violations involving risks to subjects or others occurred that have not been previously reported to the IRB?

Question Title

* 8. Since the last IRB review, have any subjects or others complained about the research?

Question Title

* 9. Since the last IRB review, have the risks to subjects changed?

Question Title

* 10. Since the last IRB review, has the magnitude of benefit to subjects changed?

Question Title

* 11. Do the risks to subjects continue to be reasonable in relation to anticipated benefits, if any, to subjects and to the importance of the knowledge that may reasonably be expected to result?

Question Title

* 12. Are any changes to the research being proposed at this time?*Note: The IRB must approve all changes to protocols and consent forms and other study documents prior to implementation.

* 12. Are any changes to the research being proposed at this time?
*Note: The IRB must approve all changes to protocols and consent forms and other study documents prior to implementation.