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A Day In the Life of Wingspan eTMF

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[Wingspan Technology Electronic Trial Master File, eTMF] [Complete, Consistent, Compliant] [Wingspan Technology eTMF, Monitoring and Managing a Study] We'll begin by logging into eTMF as Mary Murphy, a user and a study owner role. A study owner in Wingspan eTMF is a user who is responsible for setting up, monitoring, maintaining, and closing out a set of studies. eTMF provides Mary with the insight and tools needed for her role as soon as she logs in without having to drill down or run reports to understand tasks or uncover issues. When Mary logs in, she sees a set of general and study-specific announcements to keep her up to date on what's happening in eTMF, a set of notes that she's created for herself, a summary of the tasks in her inbox and the documents in her work area, and a list of the studies she's working on. The list of studies is controlled by Mary herself. eTMF automatically records her recently accessed studies and allows her to favorite the studies she works with constantly. She never needs to page through long lists of studies and drop-down menus or folder structures to find the study she's working on. The list of studies shows key information about each study, which can be sourced from a CTMS. It also keeps Mary up to date on the health of each of her studies. Visual indicators convey the completeness, [Completeness, Quality, Timeliness] quality, and timeliness for each study, the key critical to quality measures that matter most for eTMF. [Wingspan Technology eTMF, Analyzing Completeness Problems for a Study] If Mary is concerned about the health measures of one of her studies, she can click on an indicator and drill down to get more detail. For example, if she wants to understand why study M10-984 is starting to lag in completeness, she clicks on the icon and creates a report that helps her understand what is going wrong. For example, she can break down completeness by site to understand where collection of site-level documents is lagging. By sorting on completeness, she can understand which sites are lacking the most in supplying their documents. She can also generate an Excel version of this report and share it with her colleagues. [Wingspan Technology eTMF, Identifying Overdue Documents] Today, Mary is working to ensure that study 156-12-80901 is fully up to date. Looking at the dashboard, she sees two overdue documents. Clicking on the link takes her directly to the list of overdue documents. It turns out that both of them are for site 2233 in France. And both are needed to complete the package needed for site initiation at this site. Looking at the information provided, Mary can tell that the site contact details document was uploaded by the CRA, Francis O'Brian, but that a problem was found during QC so it was sent back to Francis for rework. The other document, a financial disclosure for one of the investigators, has not been collected at all. Mary will contact Francis to ensure that the past due documents are collected in a timely manner. [Wingspan Technology eTMF, CRA - Providing replacement for Incorrect Document] Francis O'Brian, the CRA, has already received an email informing him that he had a document returned to him for rework. The email includes information about what was wrong with the document. In this case there were missing phone numbers that should have been filled out within a form. As a result, he was able to obtain a replacement copy. The email also includes a link directly to the task in eTMF, so he can go right to the task, upload new content to replace the content that had the problems and the missing phone numbers, and he will be able to send the document off to QC immediately. If a new PDF rendition was needed, it would be generated, but in this case it's a PDF original. It can go directly into the QC process. He just adds a note saying he obtained a completed form. And the document will go off into another round of QC. [Wingspan Technology eTMF, CRA - Uploading a Document] Mary also reminded Francis to collect the missing financial disclosure document needed to complete the package of documents for site initiation. Once Francis has the document, he moves to the study to upload it into a waiting placeholder that was created when the study was planned. He's able to find the placeholder easily using the keyword financial. The placeholder has an extensive set of metadata that was also created when the study was set up, and as a result, Francis has to enter very little in the way of metadata to complete upload of the document into eTMF. He's able to drag and drop it directly into the waiting document placeholder. Because it's a Word document, it will be transformed into PDF as well as retaining the original Word content. Francis then moves to the work area to complete the final indexing by supplying values that would not be known in advance. He moves to the financial disclosure form and sees the PDF rendition. He also has access to a set of instructions that's provided to help him make sure that the document is correct and complete and its metadata is assigned accurately. Looking at the form, he sees that the document is dated the 24th of August 2014, so he assigns that as the document date. He received the document today, so he assigns today's date as the receipt date, and the document is in English. He just supplies one more piece of information, which is the expiration date of the document. So we'll assign that as about a year from now. And with that, he's able to release it into the QC process. The expiration date will be used to schedule a replacement document that will automatically come due when this document expires. [Wingspan Technology eTMF, Document QC] When Ned is ready to work with the tasks he's added to his clipboard, he moves into the clipboard in the View Details. Each task is presented as a document side by side with metadata, and once again Ned has access to the instructions provided by his organization for the correctness of content and metadata for each specific type of document. Ned reviews the content and metadata, and when he's finished he can mark the document as final and move onto the next document in his list. If Ned happens to find a problem with any type of document, he can fail it back either to the person who submitted it or to another user if that's more appropriate, and he always provides a code that indicates what's wrong with the document as well as any comments that clarify what needs to be done to correct them. In this case, we'll say that this document is complete and final, and that will complete our package of documents needed for site initiation for this site. [Wingspan Technology eTMF, Completeness Check] Mary Murphy, the study owner, logs back into eTMF a short time later to check up on the status of the study. She now sees that all of the documents have been received and finalized for 156-12-80901, and the study is now up to date. [Wingspan Technology eTMF, Website:, Twitter: @WingspanTech]

Video Details

Duration: 7 minutes and 33 seconds
Country: Japan
Language: English
License: Dotsub - Standard License
Genre: None
Views: 108
Posted by: thirosi on Mar 19, 2016

A Day In the Life of Wingspan eTMF

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