Page 485 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No:R200 SOP Title: Overview of Study Closure
3. The study coordinator or associate should inform the research finance group at Research.Finance@Childrens.com of the immanent study closure. Research Finance is responsible for ensuring that all invoices are billed and accounted for prior to closing the study with the sponsor and IRB.
4. All pertinent correspondence and documentation of reportable events should be filed at the IRB and be included in the study files per governing regulatory parameters, policies and Children’s Health best practices.
5. Upon fulfilment of section 5.2 below, the study coordinator should prepare the study files for long term storage. They should contact the administrative coordinator and complete the study summary form, place the study files in the Iron Mountain boxes, label the Iron Mountain boxes accordingly and help coordinate the Iron Mountain pick-up.
5.2 Sponsor Review
1. The study team should work with the sponsor to resolve all queries and documentation of reportable events.
2. The study team should fulfil the requirements of the sponsor and work with the CRO or primary contact to hold a study close-out visit with the monitor.
3. Upon resolution of all queries and documentation of such mentionable, and reportable events as outlined in section 5.1, the study coordinator or associate may close the study in the IRB upon sponsor’s request and confirmation.
4. The study coordinator or associate should work with the sponsor to return all study devices, supplies, and resources.
5. Follow the respective SOPs (see SOP titled Ordering Study Supplies) for proper and safe disposal of all unwanted and non-returnable items.
6. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
R200
10/01/20
Included reference to RA guidance and COVID command structure and the advisement to complete this process virtually whenever possible
R200