E&I requires that each approved sites submit a completed E&I Study Application Final Report - PI (Form 59A (Biomedical) or Form 59B (SBER)) at the completion of their participation in a study. If a report is received prior to the site's approval expiration date, no continuing review request will need to be submitted, even if other sites in the study are continuing study activities
If, following the submission of a Final Report or a Study Close-out it is determined that contact with a previous study subject is required, the investigator or sponsor should contact E&I prior to making contact.
E&I understands that some sponsor's may elect to leave the IRB approval open, even continuing the study, after subject participation is complete, until their database is locked. E&I will continue a study after all subject participation is complete upon request of the sponsor, but does not require it.
|Last Updated ( Wednesday, 16 September 2015 14:32 )|