Study Closure ProcessEntropy is not a method

Rachel SheppardRegulatory Director, OCRSS

Timing• Sponsor/Investigator notification of closure and data lock• No identifiable data collection after closure• Case by case review when to close with IRB

Clinical Preparation• Usually receive notification of closure• Scheduling visit and coordinating departments• Resolve outstanding queries• Have all subject source documents available• Complete IP accountability records/inventory• Prepare equipment for return• Communicate with study team (Investigators, regulatory,

financial, hospital personnel)

Regulatory Preparation• Notify IRB and Hospital offices of closure• Resolve any outstanding monitoring findings• Check all licenses and CVs• Review Financial Disclosures• Review/Provide Delegation of Authority Log• Secure any sequestered data and place with files for storage

Financial Preparation• Verify the status of A/R and payments• Notify hospital billing and contracting• Reconcile account• Review payment terms in CTA• Calculate final payment due• Review with PI

Sponsor Activities• Return/destruction of IP or instruction to staff• Review of Investigator obligations• Storage plan• Regulatory review• CRF review• AE/Deviation review• Closure of all open items• Communication of FDA status (if applicable)• Letter/email issued to site for closure

Best practice• Pre closure checklist• Accessibility of files• Know storage requirements• Request electronic CRF on CD for storage• FD after one year if change• Who keeps records• Base transfer to long term storage on audit risk