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
E&I requires that all sponsors submit a completed E&I Study Application Close-Out Report – Sponsor (Form 59C) at the time the sponsor designates all site related study activities to be complete. Following the submission of a study close-out report, the sponsor may still continue analyzing and comparing data, but retrieval of information may not include subject contact or participation.
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.