Page 484 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No:R200 SOP Title: Overview of Study Closure
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline the process and procedures for closing a clinical trial at Children’s Health System of Texas (CHST).
2. INTRODUCTION
In line with our institution’s strategic priority of quality, research administration (RA) has integrated the appropriate policies and procedures in an overview of study closure. The care taken to ensure that clinical research trials are reviewed cautiously with attention to resolution of any and all queries and issues regarding patient safety and participation in the trial prior to the closing of the trial helps us maintain our commitment to excellence. Additionally, all data and regulatory matters should be reviewed and financial invoices completed to ensure that the study is documented to have operated within the legal and regulatory parameters before being closed and study files being sent to long term storage.
3. SCOPE
The current document spans to all those who conduct clinical research at CHST.
4. RESPONSIBILITIES
4.1 Internal Review
It is strongly recommended that every research study complete an internal review to resolve and document all patient safety issues, matters of data validity, and regulatory compliance. Once these matters have been resolved, documented and reported appropriately to the respective regulatory agencies, the study coordinator or associate should inform the research finance team 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.
4.2 Sponsor Review
The study team should work with the sponsor to resolve all queries and put in place all requisite documentation in order that should the study be audited, the transparency and organization of the study files would support a favourable and good audit.
5. SPECIFIC PROCEDURE 5.1 Internal Review
Please, observe the tools and procedures in the SOP titled Internal Audits. Please, make use of the internal review tools therein and the study organization audit tool on the Department’s website.
1. The study team should complete an internal review using the aforementioned self-audit tools and resources.
2. The study team should work with their team lead to complete a review and organize the study files to ensure that they are audit ready.