eTMF Reporting Training Tools • The Pre-requisite to this course,eTMFReporting Awareness Presentation, provides you with an overview of what the eTMF Reporting tool has to offer, and how to gain access to it. • The follow-up to this course is theeTMF Reporting Powercards. They provide detailed step-by-step instructions, on how-to work with the Reporting Tool. • Both of these training tools are available on theSupport & Tools page of the eTMF website: http://gco.jnj.com/GCOeworld/eTMF/Pages/Support-Tools.aspx
Course Objective Welcome to the eTMF Reporting Tool self-paced course The objective of this course is to provide you with the basic skills you need to start working with the eTMF Reporting tool. Utilizing presentations and guided demonstrations, you will learn how to: • Select specific reports based on information needed • Run predefined Standard reports • Create Flexible reports • Save, print, e-mail, and schedule reports • Export reports to Excel format
Course Navigation • The next page contains a list of Reporting 1.4 Topics, listing a variety of report types with associated actions • If you are new to the eTMF Reporting Tool we recommend you progress through the entire course using the Next button • If you are an experienced eTMF Reporting Tool user you can select the topic of your choice from the list. At the end of each topic you will be given the option to return to the list, go to the end of the course, or move to the next topic with the Next button • The Home icon at the top will take you to the first page of this course if you wish to start from the beginning.
eTMF Reporting Overview Basic Steps for Running Reports Report Definitions eTMF Reporting 1.4 Topics Visit Report – Summary Reports Flexible Report + (Exporting to Excel) Visit Reports – Site Detail + (E-mailing) Trial Dashboard Report (and Saving) Visit Reports – Workflow Responsibility + (Printing) Saved Reports (Using Master IMP Drug Shipment) Follow Up Letters - Summary Reports Follow Up Letters – Site Detail Reports
What is eTMF Reporting? eTMF Reporting is an AGORA based reporting tool that uses information from both eTMF and CTMS, to create, store, and display reports. The 2 data sources are refreshed nightly. • The eTMF Reporting Tool provides: • A selection of predefined standard reports • Flexible reports for customized reporting • Ability to evaluate whether required documents are present in eTMF • Ability to determine if required timelines are being met
All eTMF Trial Users and eTMF Non-Trial Users automatically receive access to eTMF Reporting (with the exception of R&D Partners). Other individuals outside of these groups, who do not have eTMF application access, such as Functional Managers and Directors, may request access to eTMF Reporting by contacting CBS2 Helpdesk. Automatic login no password required Note: Users without eTMF access will need to request access to the eTMF Reporting by contacting CBS2 Training is highly recommended Users include:
Access to eTMF Reporting Tool Links to access the eTMF Reporting Tool are available at several locations: • Every page on the eTMF website http://gco.jnj.com/GCOeworld/eTMF/Pages/eTMFHomepage.aspx also • GCO Portal Home page http://gco.jnj.com/Pages/default.aspx
What’s In It For Me? Below is an overview of some of the areas that the eTMF reports address
eTMF Reporting : Getting Started The eTMF Reporting STARTPAGE displays descriptions for each of the report types
At the Top of every Visit Report and Follow Up Report is a Report Definitions link
Selecting the Reports Definition link opens a PDF file in a separate window. It contains detailed descriptions of each report type in that group. Select the hyperlink for the report of your choice.
Each hyperlink takes you to the page that contains the detailed description of that report. You have the option to save the Report Definition PDF or print out the pages.
Running Reports • From the STARTPAGE you select the report type that fits your need. • Each Report has a format which it uses to display the information based on the data set that you choose
Running Reports • To run a report follow this typical 6 step method: • Select a report • Select Protocol, Therapeutic Area, or Compound parameters • Generate Regions (List updates based on selection in Step 2) • Select Region(s) (Optional) • Select Optional Parameters (selections change for each report) • Run the report (Finish) • (Note: it is important to not leave all the fields blank on every screen, or the system will try to produce a report on everything. This could result in freezing the system)
The Flexible Report • Flexible Report • Flexible Reports provide the ability to create a customized report displaying the information that you choose. • They are not meant to augment or replace the existing predefined standard reports • They are not to be used for safety or regulatory decisions • They can report on information from Compound(s), Protocol(s) or any level within trials
Flexible Report Demonstration In this demonstration, you will learn how to Run a Flexible Report, and how to Export the reportto Excel Format. Click the Next button start the Demonstration
Purpose of Visit Reports Visit Reports are designed to support the harmonization effort that stream lines the process flow of SVR’s from Visit End Date through final approval.
Purpose of Visit Reports Improved Reconciliation – • Summary counts across All Trials, Therapeutic Areas, Protocol, Region and Site levels • Identify missing documents more easily Better Quality & Audit Readiness - • Track Compliance to the required 15 business day timeline for creating and approving Site Visit Reports • View detailed and cross study metrics, identify trends and take corrective action Collaborate - • Compare the visit reports in eTMF to the corresponding reports in CTMS
Visit Report - Summary Report • The Visit Report - Summary Report: • Provides summary counts at Protocol Region and Site levels • Displays dial graphs and metrics across all studies • Provides 4 levels of drill down Summary Reports • Therapeutic Area (TA), Protocol, Region and Site • Can display summary counts for each document type
Visit Report – Summary Report Demonstration In this demonstration, you will learn how to run a Visit Report - Summary Report and drill down to Therapeutic Area, Protocol, Region and Site Summary Reports Click the Next button start the Demonstration
Visit Report - Site Detail Report • The Visit Report – Site Detail Report: • Site details for one or more Therapeutic Areas, Protocols, or Regions • Displays dial graphs and detailed metrics for each document within the selected site(s) • Can be used to identify missing documents and monitor the status of existing documents
Visit Report – Site Detail Demonstration In this demonstration, you will learn how to run a Visit Report – Site Detail Report and e-mail the report. Click the Next button start the Demonstration
Visit Report – Workflow Responsibility • The Visit Report – Workflow Responsibility Report: • Displays detailed metrics for individuals involved in the process flow of the Site Visit Report in eTMF. This includes individuals who: • Initially imported the document • Initially submitted the document for approval • Approved the document • Are produced for one individual at a time • Will display all the trials where the individual has a role in an SVR approval process, based on your filter criteria • Will be used by GTMs and Functional Managers to monitor the status and compliancy of their staff
Visit Report – Workflow Responsibility Demonstration In this demonstration, you will learn how to Run a Workflow Responsibility Report, then Print the report. Click the Next button start the Demonstration
Follow Up Letters – Summary Report • Follow Up Letters – Summary Report: • Can be used to identify required Follow Up Letters are filed in eTMF and monitor the status of the existing ones • Provides cross study metrics and dial graphs for the selected Therapeutic Area(s). Protocols, and Regions • Provides Total # of eTMF visit reports requiring Follow Up Letters, along with total number of Follow Up Letters • Follow Up Letters are required for all: • Site Initiation Reports (SIRs) • Monitoring Visit Reports (MVRs) • Remote Monitoring Visit Reports (RMVRs • Site Closure Reports (SCRs)
Follow Up Letters – Summary Report Demonstration In this demonstration, you will learn how to Run a Follow Up Letter - Summary Report Click the Next button start the Demonstration
Follow Up Letters – Site Detail Report • Can be used to identify required Follow Up Letters are filed in eTMF and monitor the status of the existing ones • Displays each Site Visit Report for the selected site and identifies whether or not a Follow Up Letter has been created for that document. • LTMs and SMs as will use this report to identify missing documents • Follow Up Letters are required for all: • Site Initiation Reports (SIRs) • Monitoring Visit Reports (MVRs) • Remote Monitoring Visit Reports (RMVRs • Site Closure Reports (SCRs) • The Site Detail Report can be accessed from the StartPage or by drill through on a Region Summary Report
Follow Up Letter Site Detail Report Demonstration In this demonstration, you will learn how to Run a Follow Up Letter - Site Detail Report Click the Next button start the Demonstration
The Trial Dashboard Report Displays whether documents are Missing or Existing in eTMF Create a Dashboard Report for any desired combination of Trial Filing Areas: CAF, LAF and IF Select the option: Missing and Existing or Missing Only Select one Protocol at a time The Trial Dashboard Report
Trial Dashboard Report Demonstration In this demonstration, you will learn how to Run a Trial Dashboard Report, and how to Save a report. Click the Next button start the Demonstration