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Managing Study Expirations

Managing Study Expirations. Michelle Stickler Virginia Commonwealth University 804-828-0131 mcstickler@vcu.edu. When does a study expire?. Continuing review has not occurred by 11:59pm on the expiration date Study is expired at 12:00am the day after expiration date

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Managing Study Expirations

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  1. Managing Study Expirations Michelle Stickler Virginia Commonwealth University 804-828-0131 mcstickler@vcu.edu

  2. When does a study expire? • Continuing review has not occurred by 11:59pm on the expiration date • Study is expired at 12:00am the day after expiration date • Studies that are conditionally approved are not considered expired even if all conditions have not been met

  3. What can be done to prevent study expiration? • Send reminder notice(s) to PI, others • Set deadline for submitting continuing review paperwork • Decide how far in advance to send notice(s)

  4. When a study expires… things to consider • Who needs to be notified? • Principal investigator • Research coordinator • Department chair • Sponsored programs • How will notice occur? • Immediate and reliable method needed • Do you want verification that notice received?

  5. What does expiration mean? • No study activity may occur including • Recruitment • Data collection • Interventions/interactions • Data analysis • No sponsored spending related to IRB approved project • Expiration is not a suspension or termination

  6. What is in the best interest of subjects? • Option for continuing subject interventions • When in best interest of participants • PI makes initial assessment • IRB must confirm via expedited review or convened meeting • May apply to all subjects or a subset

  7. What repercussions to study expiration might be considered? • Limited time frame to obtain continuing review • Inability to reopen study • Disallow spending to the funded project supporting the study • 3 strikes and you’re out • Multiple instances may be deemed continuing noncompliance

  8. QUESTIONS?

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