Society for Clinical Trials 37th Annual Meeting 2016 Study Cl se ut Society for Clinical Trials 37th Annual Meeting 2016 Developing a Comprehensive and Effective Process for Closing Out a Study: Strategies From Closing Out Multi-Site Substance Use Treatment Clinical Trials Introduction of myself, maybe ask if anyone has ever participated in a close out of a study? Dee Blumberg, Donna Brown, Kayla Daniels, Denise King, Beth Jeffries The NIDA CTN Clinical Coordinating Center at The Emmes Corporation - May 18, 2016

Study Close Out Preparation Scheduling Managing study close out: Safety & regulatory Data cleaning Storage & record retention Study personnel Medication & supplies Follow up

Study Close Out Preparation for an efficient close out begins before the study starts Careful and timely execution of all trial-related duties throughout the implementation phase will aid the close out process Study closeout activities are performed to confirm that the site investigator’s study obligations have been met and post study obligations are understood. Closeout activities verify that study procedures have been completed, data collected, and if relevant, study intervention is returned to the responsible party or prepared for destruction. Begin early- should incorporate in MOP …

National Drug Abuse Treatment Clinical Trials Network Multi-center Trials Multisite trials Research sites in the U.S. and Canada Clinical Coordinating Center (CCC) at Emmes Central Regulatory document collection Central QA, Safety, and Medical monitoring Site activation, monitoring throughout the study and close out From our abstract: The close out phase is an extremely important component of any clinical trial, and requires forethought and careful planning in order to be successful and efficient. This process may be particularly complex with multi-site trials, where an additional layer of coordination is necessary. For over 10 years the National Institute on Drug Abuse (NIDA) Clinical Coordinating Center (CCC) has supported the National Drug Abuse Treatment Clinical Trials Network (CTN) which test substance use treatment interventions in multi-site clinical trials. Throughout that time, the CCC has developed best practices for a methodical, cost-effective and successful study close out process.

Preparing for Study Close Out Strategies for Efficient Close Out Close Out Readiness Checklist Comprehensive Detailed Clear Provided far in advance of close out Close Out Readiness site calls- assess the site’s status and progress with close out tasks Strategies: Do whatever you can remotely (sometimes entire SV will be remote…) Provide tools to help sites prepare- e.g., calls, checklist… Keep everyone in the loop- monitors… An interdisciplinary team within the CCC and Data and Statistics Center (DSC) work closely together to monitor and guide the sites with their regulatory, safety, data, supply, and medication related assignments in order to ensure that close out is accomplished in an organized and timely manner.

CTN Site Close Out Checklist Strategies: Do whatever you can remotely (sometimes entire SV will be remote…) Provide tools to help sites prepare- e.g., calls, checklist… Keep everyone in the loop- monitors… An interdisciplinary team within the CCC and Data and Statistics Center (DSC) work closely together to monitor and guide the sites with their regulatory, safety, data, supply, and medication related assignments in order to ensure that close out is accomplished in an organized and timely manner.

CTN Site Close Out Checklist Detailed- rather than saying “make sure all your reg docs are in the binder” we provide very specific list of what we expect. Clarity- for each item we clarify the method of submission, whether it has been submitted to RTS and placed in binder, and whether and when that has been verified….

Scheduling Study Close Out Monitoring site progress via the close out readiness checklist and readiness calls assists with scheduling the Close Out Visit at the right time Many tasks can be performed and confirmed remotely in advance of the visit (e.g., collection of regulatory documents) The study monitor will schedule the visit (give several options) and specify which site staff must be present

Components of Site Close Out Monitoring Visits Study Personnel Medication, Supplies & Equipment Safety & Regulatory Data Cleaning Storage & Record Retention When I talk about these go clockwise… For storage say important to have contact person. Add some wording on each that gives some info, like storage and record retention LOCATION, medication supplies DISPOSITION… An interdisciplinary team within the CCC and Data and Statistics Center (DSC) work closely together to monitor and guide the sites with their regulatory, safety, data, supply, and medication related assignments in order to ensure that close out is accomplished in an organized and timely manner. All outstanding Case Report Forms (CRFs) have been corrected, collected, organized, and filed as required. All data queries are corrected and resolved All serious adverse events (SAEs) have been reported to the DSMB (or Safety Monitor), sponsor, Institutional Review Board (IRB), and other organizations, as specified in the protocol. All adverse events and serious adverse events (SAEs) are recorded and followed up to resolution in accordance with procedure detailed in the protocol. Campanella, M. (2013). CTN Webinar: Site closeout – An overview. Retrieved from http://ctndisseminationlibrary.org/display/974.htm.

Following Up After Study Close Out Report distributed with outstanding issues and pertinent findings Action item memo distributed – indicating completion A regulatory report is attached - A study close out visit report is sent including site status, any outstanding issues and pertinent findings - The CCC staff follows up on all action items and ultimately issues a memo that acknowledges that all action items identified during close out visit have been completed - A report is attached to the memo, summarizing the list of regulatory documents that are on file at the CCC

Lessons Learned Start thinking about and preparing early in study, checklist should be prepared in advance We’ve done trainings on close out before happens to tell them what to expect, reduce confusion and anxiety Incorporate steakholders- close out is a collabortive process, calls and checklist should reflect this too- all should input… Have all info in same place- checklist should be inclusive…

Thank You! Questions/Comments? For more information contact: Dee Blumberg Project Manager, Clinical Coordinating Center National Drug Abuse Treatment Clinical Trials Network The Emmes Corporation 401 N. Washington Street, 7th Floor Rockville, MD  20850 Phone: 301-251-1161 ext 2867 Fax: 301-576-3924 Email: dblumberg@emmes.com Thank You! At some point in slides need to talk about site staff leaving, checklist helps them get stuff done before everyone is off, and also sites should understand expectations so know who needs to stay (e.g., someone that can handle data queries…)