About

​Executive Summary

​Memorial Sloan Kettering (MSK) runs one of the largest clinical trials programs for cancer in the USA. Offering nearly 2000 IRB-approved prospective protocols to MSK patients for both therapeutic and non-therapeutic intent, our portfolio is enhanced by clinical research opportunities that are led by pharmaceutical companies, federal agencies and consortia, etc. The ability to partner with these groups and offer their clinical research studies to the MSK community relies largely on the ability efficiently exchange information and documents. The current method for such exchanges relies mostly on point-to-point e-mail correspondence, leading to delays and inability to trace at any given time how many studies require an amendment.

​Background

​Protocol document sharing and amendment processing for clinical research is inefficient for both internal and external stakeholders. A need was identified to introduce centralization and standardization to reduce processing times as well as use one consistent method of document exchange and communication for internal and external stakeholders. By leveraging Microsoft’s Power Apps Platform, we are creating a Documentation Portal known as PowerDOCX not simply as a centralized storage location, but as an automated intelligent system that kickstarts the review and operationalization process before it even falls into the work queue of an MSK staff member. PowerDOCX Core

​Features

​PowerDOCX will consist of two primary user interfaces: an internal MSK staff view and an external view available for sponsors and clinical research organizations (CRO). Both views will leverage automated notifications, approval requests, and an interactive user interface to manage protocol document sharing. Main screens that will be developed for the sponsor and CRO view: • New Submission: This screen will allow users to submit a new set of protocol documents, but with certain conditions that will allow us to ensure that all appropriate documentation is received based on the content of the protocol version provided. This will be implemented by asking questions to the user, which will prompt them to submit documentation based on the answer provided. Alternatively, the user will be prompted to upload documents and then subsequently asked to provide details about them via codified questions. While the new submission form requires active user interaction, this platform will make the submission more intuitive and efficient than sending an email.
• Manage Submissions: After an initial submission, the user will have the ability to view their previous submissions as well as amend them to append new documents. When amending previous submissions, the user won’t have the ability to replace previously submitted documents, only upload new ones that weren’t previously submitted. Also, within this screen, they will be able to view where in the processing stage this protocol version is in the review pipeline and who their point of contact is for additional questions.
Main screen that will be developed for the MSK staff member:
• View Submissions: This screen will allow the MSK user to view the protocol documents and information provided by the sponsor or CRO. They will be able to view the documents the sponsor submitted, the questions they answered related to those documents, and any changes made after the original submission. Also, the MSK user will be able to assign statuses to the submission, which will then be viewed by the sponsor or the CRO.

Future Integrations

​While PowerDOCX is an initial introduction into consolidating sponsor documentation sharing, it opens a pathway to future integrations with other Microsoft-developed products at MSK, such as PowerPIMS. As PowerPIMS builds out functionalities to manage protocol information, statuses, and requirements, the PowerDOCX will build out how documents are received and managed. In the interim, while we test these processes for amendments, there is high scope for an integration in which the portal can be rolled out to manage all protocol documentation, including those required for protocol activation. More immediately, the ability to seamless insert PowerDOCX into existing operational workflows reliant on Microsoft products, such as Teams, Outlook, e.g., makes this tool even more desirable and easy to adopt by the MSK clinical research workforce. Success Metrics The most immediate key indicator will be the ability to readily identify and quantify what sponsored studies require an amendment to be processed as they are distributed by the study sponsor. Furthermore, we will be improve the turnaround time in processing the study amendments. The most significant cause of delay in the current workflow is because we often receive an incomplete packet of protocol appropriate documentation to process them at MSK. By measuring the current time to completion and comparing it with the future outcome, we can measure whether PowerDOCX is contributing to reducing the amendment processing timelines. 

​Conclusion and Next Steps 

With the expected benefit of a centralized document management and tracking system, we not only expect a reduction of manual work, but also an improved processing time for amendments along with a defined workflow that characterizes how amendments are handled across the enterprise. While PowerDOCX is still in development, our next steps include working with sponsors on testing and improving the user experience as well as partnering with more services across the organization. Until the initial go-live towards the beginning of Q3 2023, development will continue to map documentation routing, automated notifications, permission handling, etc. We will continue to engage the support of Clinical Research staff to ensure this product is in line with best practices as well as current workflows that help streamline the overall backlog of MSK’s amendments