What are the requirements for notifications of study closure at research sites?

Question:

What are the WCG IRB requirements for notification of study closure at the research site? Specifically, does the close out visit need to have taken place before submission?

– Director, CRO

Response:

There is no regulatory or WCG IRB requirement for the closeout visit to take place before notifying the IRB of the study closure at a research site.

WCG IRB considers the study open at a site until a study closure report is received. A study closure report may be submitted when all participants have finished all protocol related interventions, interactions, final visits and follow-up (including collection of data) and the sponsor confirms the site can be closed.

Although not required, many sponsors will complete the close out visit before confirming the site can close out the research with the IRB to ensure they have continued oversight if anything further is needed. 

Also note that if the study is federally funded and conducted under a Federalwide Assurance, the study must remain open until no additional identifiable private information about the participants is being obtained; and all data analysis at the site is complete.