Introduction. Lesson 1 Access and Basic Navigation

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1 Introduction Hello and Welcome to PRA s etmf Basics for External Users This tutorial is designed to provide you with a basic overview of PRA s etmf 3 System that you will be using to access your Trial Master File documents There is an etmf 3 System User Manual designed for the External User that will provide additional information and step by step guidance for the tasks noted in this tutorial. You can access a copy by clicking the button on the screen. When you are ready, select a lesson in the Table of content to begin Lesson 1 Access and Basic Navigation Once you receive access to PRA s etmf 3 system and have been provided with your study URL you will be able to log in using Internet Explorer version 8 or higher browser. Using the credentials provided - enter your user name and password. PRA e etmf 3 system will open with your Clinical Trial Workspace. The home page will provide you access to the etmf 3 libraries in the Quick Launch Bar Access to the Libraries is based on your assigned permissions. If you try to access a section and do not have the required permissions, you will see this error. Use your browser back button or Browser History list to return to the home page of the workspace. Typically external users will only have access to the Trial Master File libraries. Menus and Tabs in the tool bar will be available based on the screen that you are currently viewing. You can refer to the etmf 3 System User Manual for External User for more information on menus tabs and toolbars. To properly log off PRA s etmf 3 system, use the Sign-out option in the User Actions Menu Lesson 2 Locate and Open a Document Documents are filed in etmf 3 based upon the approved Trial Master File Specifications. To locate and open a document for viewing, select the applicable Library or Domain. The Group Name folders will open, click the desired folder to display a list of the documents filed within that group. Note, etmf 3 will only display 30 items in each screen. If additional items are filed in this section, you can use the next back buttons to navigate through the lists. The list can be filtered and sorted using the column headers. For example, I want to find the Trial Master File specifications for the study, using the drop down list in the Artifact Name column; I can filter for only that document. Once located, click on the Name hyperlink to open and view the document. 1

2 Note by default, documents in their native format that is Word, Excel, PowerPoint etc. will automatically open in a new window. Pdf documents will open in the same window as the etmf 3 application. To open a.pdf in a new window, right click on the pdf and select the open in a new window option. Lesson 3 TMF Specifications So what are the TMF Specifications when and how are they developed and approved, where are they filed and when, what information can you find in this document and how will you use it. In this section, we will take the opportunity to answer all of these questions. PRA 055 Trial Master File Management SOP states that the TMF Specifications is a trial-specific document that includes: TMF Index (i.e. classification system) Requirements for what documents must be original/wet-ink Structure of the supplemental paper TMF and what must be filed as paper Frequency and method of TMF delivery Other TMF agreements, including Sponsor requirements The TMF Specifications are initially drafted by the TMF Coordinator, who provides them to the Project Manager and sponsor for review, modification, and ultimately approval. Bear in mind, this is the sponsor s TMF ultimately, the deliverable should cater to their expectations. Sponsor specific requirements regarding filing, maintenance, and delivery of the TMF are documented in the TMF Specifications. Any modification to PRA s TMF Standards for your specific study will also be documented here. Optimally the TMF Specifications will be approved and filed prior to the creation or receipt of project documents that are required to be filed in the TMF. Project team members will need to reference this document in order to ensure a quality TMF, as well as to know the proper filing locations and naming conventions for the documents. In the event of the delay in the client response or approval, the project team will use PRA Standards to identify original or wet-ink requirements, as well as the filing location and appropriate metadata until the TMF Specifications are approved. Let s start with some terminology; keep in mind these terms are defined in the system manual and TMF Specifications The TMF Index This is the classification system based on the industry standard mentioned early the DIA TMF Reference Model with minor modifications to suit PRA s business practices. The basic premise of the TMF Index is that documents are classified as either trial, country or site files (in other words, domains) across eleven zones (or major classifications) and include further division within those zones (that is, sections and artifacts). The term Domain is interchangeable with library. These are the major divisions of the TMF: Trial, Country, and Site divisions; and when applicable, Unblinded Trial, Unblinded Country and Unblinded Site. 2

3 The term Zone refers to the major classification within the Domains where similar activities are grouped together and can exist across all domains. For example, the IP and Trial Supplies zone will exist at the trial, country and site domains. These zones are defined in the TMF Specifications 1 - Trial Management 2 - Central Trial Documents 3 - Regulatory 4 - IRB / IEC and other Approvals 5 - Site Management 6 - IP and Trial Supplies 7 - Safety Reporting 8 - Centralized Testing 9 - Third Parties 10 -Data Management 11 - Statistics Group Name These are the classifications (or groupings) of documents within a zone. The group name is a combination of the DIA TMF Reference Model's Zone and Section. For example, the zone 01-Trial Management and one its sections Oversight make up the group name: Trial Management - Oversight The Artifact is the final and lowest-level classification of documents. Defined in the Reference Model are document types, referred to as artifacts. These are the document types (or artifacts) which one would expect to find in a TMF. Artifacts within the zones may exist at multiple levels. For example, an artifact, such as Safety Management Plan exists at only one of the levels the trial level. In contrast, the artifact Informed Consent can exist at all levels Trial, Country, and Site. Artifact numbers are a combination of the zone, section and artifact. Most zones contain a section for 'general' artifacts, such as: Relevant Communications, Tracking Information, Meeting Material and Filenotes. Details on how to use these sections can be found in the TMF Specifications and are reviewed in another module Perhaps a visual representation might help to clarify this concept. There are 3 Domains Trial, Country, and Site Within each of these domains there are 11 classifications these are the zones. So you may have documents of the 01 Trial Management classification (for instance, an audit certificate) which would be appropriate for filing at the Trial level, Country level, and/or Site level The grayed out areas indicate zones which will never be applicable for that domain. So, here you can see a representation of the structure. To file a document or artifact, it would be placed in its appropriate zone, within its appropriate domain. As you can see, the zones repeat across each domain. 3

4 There could additionally be three more domains if the study has an unblinding component, there would also be corresponding unblinded Trial, Country, and Site domains. We will discuss the specific zones and their contents in another module. Each artifact, as listed, includes all approvals, versions, amendments, change summaries, translations and certificates, unless specifically listed as a separate artifact. These items will be uniquely identified with metadata. If applicable to the trial design, documents which contain information that can potentially and/or unintentionally unblind a member of the Project Team are filed in a restricted, limitedaccess area of the TMF and etmf. In addition to having trial, country and site domains, these projects will also have corresponding unblinded trial, unblinded country and unblinded site domains in order to store the unblinded monitoring visit documentation, Investigational Product temperature excursions and accountability, safety reports and randomizations. On the Specification tab of the TMF Specs, you can find the key PRA TMF Standards specific to your project, PRA builds expectation to ICH GCP, the EMA Reflections Paper on the Trial Master File and other local regulatory requirements (such as the MHRA Good Clinical Practices Guide).. These are described in the document PRA 055 R 01 PRA TMF Standards and in another module Here you will find the specific information regarding the Filing Structure of your project, the documents required for your project, which of those documents require original Signatures or Approvals, as well as, the Delivery requirements for your project. It is critical for all document owners to understand the PRA TMF standards The standards are modified as needed to suit the written preferences of our Sponsor as this is their TMF. The agreements between PRA and the sponsor are documented in the TMF Specifications so every etmf user should be familiar with how to locate and interpret this document for their project The Specifications tab highlights the key decisions that have been agreed upon with the sponsor. When you look at the tab, you can quickly determine if the study is following PRA Standards or if there are project specific requirements for your study. If there s nothing in the far right column, the sponsor has accepted our standards. If there is a source document listed in the far right column, the project team should familiarize themselves with the sponsor-specific modifications as they may be required to execute some or all of these non-standard requirements. Now that we have a better understanding of the definitions, the zones and the standards, let s take a closer look at the TMF Index tab as it relates to key PRA standards concepts. As noted in PRA 055 SOPs and Work instructions, the TMF Index is a key input to the TMF Specifications, and describes: Type of required TMF documents By what trial milestone the required documents must be in the TMF Who (that is PRA, Sponsor or 3rd party) is responsible for collecting or creating TMF documents and where they reside 4

5 etmf 3 users will use this index to find the filing location of a document within their TMF or to identify the appropriate metadata to add to a document when filing it in the system To determine where to file a document, there are two columns to assist. The Artifact Name is actual name of the documents as presents in etmf and will be used in the naming convention of the document. The Equivalents column provides types of documents that may be filed as that artifact; this includes common industry references and similar terminology that is considered an equivalent to the PRA artifact name. You can use the filter to quickly search for a specific document or group of documents. For example, I have a CV I need to file. Using the filter in the artifact column, I can easily find all of the documents that contain my search criteria. Now I only see the records for the CV artifacts and know that my PI CV will be filed in Zone 5 - Site File Domain - Site Management - Set-up Group with an Artifact Name of CV - PI This will be reflected in the TMF section of my trial workspace. The domain column then signals whether the artifact can be filed at any level trial, country or site or whether the filing is limited to certain domains. There are also artifact descriptions which further describe the intent of the artifact. Be sure to reference the comment field, as this may direct a user to a more appropriate filing location; for example, the Medical Monitoring Plan redirects the user to file in Safety and Medical Management Plan artifact # , unless not contracted for Safety. Once you have identified where to file a document, the following fields assist you in applying the necessary additional metadata in the etmf Smart document feature. Reference Date the date that should be used as the document date in etmf and becomes part of the system generated document name. The Required Document Description is generally optional; however certain documents require additional details that cannot be mandated by the system. Use this column to determine what additional detail should be entered in the free text Document Description field. The Required document field determines whether the document is automatically configured in the etmf checklists and is tailored to the sponsor requirements. The Milestone, if required determines when the document is expected to be filed in the TMF and to which etmf checklist the document aligns. Filed in PRA, Sponsor or 3rd Party TMF? is used to facilitate a complete PRA TMF and to conduct audits/inspections. Remember, using the information in the TMF index will help ensure you have an Inspection Ready TMF 5

6 Lesson 4 Using the TMF Specifications The Trial Master File Specifications contains the TMF Index. This is a list of all required documents for the study and includes the filing location along with other requirements. Filters are built into the document to allow users to quickly locate information pertaining to specific document. This will guide users to the filing locations for each of the Trial Master File documents. For example, a user wants to find the Project Management Plan. In the Artifact filter type Plan in the search field. All of the documents containing the word Plan in the Artifact name will display Here you can easily see that the PMP will be filed in the Trial Section Library or Domain, The Trial Management Trial Oversight folder or group name and will have the Artifact name of Project Management Plan. Lesson 5 Document Menus and Options Using the information from the TMF Specification users can quickly Locate the PMP Selecting a document will open the tools in the documents ribbon Here you can view the past versions of a document a link to the document Or set up an alert for the document Alerts will send the user notifications every time an action is performed on the document matching the selected criteria For example, users can be notified anytime the document has been changed. Set the alert and when a change is made, you will be notified via at the time points set in the alert. Other document menus are available in the document drop-down menu. This is where you can access the audit log for the document identify who has reviewed and if applicable approved the document. In the Library ribbon Users can change their view of the document list to a spreadsheet view and export to excel Lesson 6 Using Views Views are available to allow users to view documents based on identified criteria. Here for example, you are viewing the Site Section Library and see a list of all of the Sites. By selecting a specific investigator users can see the group folder for the documents. Changing the view from Group Names to All documents now displays all of the documents for the Investigator without having to navigate to a specific folder. Users can filter and sort using the column headers or export the list into Excel as a report. 6

7 Lesson 7 Exporting Documents and Folders etmf 3 users can export individual documents or document folders to their computers without opening each individual document and saving it. From the Library Tab, click on the Open with Explorer option in the Connect and Export tool To export folders and all of the corresponding documents, drag the containing folder to your desktop. To export individual documents, navigate to the desired document - drag the desired document(s) to your computer. Remember these exported documents are not linked to etmf 3. Updating the document on your computer will not update the version in etmf 3 nor will your local document be updated if the version in etmf 3 is updated. Lesson 8 Review Let s review etmf 3 is accessed using an Internet Explorer browser version 8 or higher Access is based on your permissions you will receive an error if you do not have permission to view a specific area. Use the Trial Master File Specifications to easily identify where a specific document is filed To open and view a document, click on the Name hyperlink or right click and select open in a new window. Ribbons and Document Menu options will allow you to view prior version of a document, set alerts, links to documents, or view the audit log for a document. Thank you for your time and attention in viewing this tutorial. Remember that you can always revisit any module in this tutorial to review a specific topic and also access the etmf 3 System User Manual External User guide for step by step guidance to perform the tasks noted in this training. 7

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