eTMF Reporting Tool 1.4 v. 1.0, 31-Mar-2008

eTMF Reporting Training Tools   The Pre-requisite to this course, eTMF Reporting 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 the eTMF 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 the Support & Tools page of the eTMF website: http://gco.jnj.com/GCOeworld/eTMF/Pages/Support-Tools.aspx

Welcome to the eTMF Reporting Tool self-paced course 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 1.4 Topics eTMF Reporting Overview Basic Steps for Running Reports Report Definitions 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) Trial Dashboard Report (and Saving) Follow Up Letters – Summary Reports Follow Up Letters – Site Detail Reports

eTMF Reporting Overview

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

Users include: 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

Who uses which reports?

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

eTMF Reporting 1.3 StartPage

What’s In It For Me? Below is an overview of some of the areas that the eTMF reports address v. 1.0, 31-Mar-2008

Report Definitions

Report Descriptions

eTMF Reporting : Getting Started The eTMF Reporting STARTPAGE displays descriptions for each of the report types Review descriptions of each report type. Flexible Report: just as it reads – Read red text. Visit Reports: Determine the presence of visit reports. Summary report gives totals and you can drill into details at site level. Also shows cross reference to CTMS visit reports Master IMP: locate documents related to drug shipment. Provides a list of typical drug shipment docs to look for, and ability to customize list for regional needs. Summary reports give you totals at protocol and region levels and allow you to drill into the details. Read Red text References Report: Reports on documents that are stored in CAF, LAF or IF, and referenced to another filing area. Dashboard Reports: Reports on missing and existing documents in a filing area or across multiple filing areas. Mention: Report data is not real time, even though it is updated daily, it is based on data posted the night before. reports must not be used for any GxP purposes or used to make any GXP decisions

At the Top of every Visit Report and Follow Up Report is a Report Definitions link v. 1.0, 31-Mar-2008

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. v. 1.0, 31-Mar-2008

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. v. 1.0, 31-Mar-2008

Running Reports

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)

Flexible Report + Export to Excel

The Flexible Report Flexible Report Flexible Report– Informed Consent Use Choose a different Protocol Search Method Compound: 26866138 Generate the Protocols and Regions for the selections made above Protocol: 26866138MMY3021 Regions: pick one (USA?) Sites: All Filing Area: CAF, LAF, IF Document Types: select all ICF docs ICF Master Review and Approval Form ICF International Genetic Testing ICF Trial Master International ICF Country Specific ICF Country Specific Genetic Testing ICF Site Specific ICF Site Specific Genetic Testing Section/subsection: 02. Trial Documents/, 02.05 Informed Consent Form Attributes Site Document Type Document Name Document Status Version Created By Creation Date Actual Filing Area   Finish 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 v. 1.0, 31-Mar-2008

Flexible Report Demonstration In this demonstration, you will learn how to Run a Flexible Report, and how to Export the report to Excel Format. Click the Next button start the Demonstration

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The Visit Report - Summary Report

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 v. 1.0, 31-Mar-2008

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

Summary of all visit reports in Belgium & France Drill down to Detail on one Belgium site Refine your detail: Filter on Monitoring visit Report show in PDF, return to HTML Select Belgium from Summary, filter on MVR Visit Report Visit Report Summary Keyword: riv Protocol: RIVAROXACS3001 Regions: France, Belgium Click Next Generate Site list: No Document Types: All Attributes: All Click Finish Click on Belgium site with most monitoring visit reports Refine report by apply narrower filter Document Types - Monitoring Visit Report   Hide selected parameters  show in PDF, return to HTML v. 1.0, 31-Mar-2008

Visit Report - Site Detail Report + e-Mailing the Report

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 v. 1.0, 31-Mar-2008

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

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Visit Report – Detailed Reports Workflow Responsibility

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 v. 1.0, 31-Mar-2008

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

Visit Report – Workflow Responsibility v. 1.0, 31-Mar-2008

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) v. 1.0, 31-Mar-2008

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 – Summary Report Demonstration v. 1.0, 31-Mar-2008

Follow Up Letters – Site Detail Report

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 v. 1.0, 31-Mar-2008

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

Follow Up Letter Site Detail Report Demonstration v. 1.0, 31-Mar-2008

The Trial Dashboard Report + (Saving a Report)

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   Dashboard Report – Missing & Existing ICF docs Search for CNT Select protocol : CNTO1275PSA3001 Generate Regions - don’t select any explain that means all Next  Filing Areas – CAF & LAF Document types: All Click 2nd generate bar (explain narrowing filter) Filing areas: 02 Trial Documents  Select No to Signature names and dates (Mention Back button) Click Finish Hide Parameters (more real estate) Note what no documents found means (may or may not be meaningful) Page down to a regions with docs – Canada – Great Britain Shows if source or reference – Great Britain Note diff between report date and print date Page numbers not in HTML You are GTM - Decide to report only on CAF Choose no regions (under USA on list) – Refine Report Switch to PDF view Note: Disclaimer on bottom, Mention printing from PDF Send report to yourself via Email – Keep this version – Email Report, include link and attach report v. 1.0, 31-Mar-2008

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

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Running Previously Saved reports v.1.1, 18-April-2008 v. 1.0, 31-Mar-2008

Running Previously Saved reports Previously saved reports are stored in the eTMF Shared Reports Folder and the My Folders tab Click the Home icon on the StartPage to switch to the eTMF Reports Folder area v. 1.0, 31-Mar-2008

Running Previously Saved reports Access to the folder area from the STARTPAGE you Click the Home icon on the StartPage to switch to the eTMF Reports Folder area Home Icon v. 1.0, 31-Mar-2008

My Folders Reports that you save, are stored in My Folders Run this Drug Shipment Report Previously saved. CREATE THIS REPORT IN ADVANCE Master IMP Drug Shipment Report Compound: 26866138 Protocol Status: In Progress Click Generate Protocols & Regions Protocol: 26866138MMY3021 Regions: Argentina Click Next Sites: Select All Site Status: Only In Progress Document Types: Investigator financial Disclosure form, curricula vitae Additional doc types: No additional Document Type Required Document Statuses: Leave as Approved and In use Attributes: Deselect Signature Names and Dates Click Finish R Click Argentina site and select Detailed Report Hide Selected parameters View as PDF Save this report Reports that you save, are stored in My Folders A Saved report is a static snapshot from the date it was saved v. 1.0, 31-Mar-2008

Shared Reports Run this Drug Shipment Report Previously saved. CREATE THIS REPORT IN ADVANCE Master IMP Drug Shipment Report Compound: 26866138 Protocol Status: In Progress Click Generate Protocols & Regions Protocol: 26866138MMY3021 Regions: Argentina Click Next Sites: Select All Site Status: Only In Progress Document Types: Investigator financial Disclosure form, curricula vitae Additional doc types: No additional Document Type Required Document Statuses: Leave as Approved and In use Attributes: Deselect Signature Names and Dates Click Finish R Click Argentina site and select Detailed Report Hide Selected parameters View as PDF Save this report eTMF – Shared Reports are stored in a folder link on the Public Folders tab v. 1.0, 31-Mar-2008

Shared Reports Only CBS2 can make entries to the Shared Reports folder CBS2 will name the reports at the time of placement Shared Reports follow this naming convention: v. 1.0, 31-Mar-2008

Shared Reports For more information on Shared Reports go to the Support and Tools page on the eTMF website. the eTMF Support and Tools webpage contains the links: eTMF Reporting Powercards: (Navigate to Additional Reporting Options) Shared Report Name & Folder Structures Shared Report Request Form Shared Report Request Selection Sheet v. 1.0, 31-Mar-2008

eTMF Report Folder Area In this demonstration, you will learn how to work with reports saved in My Folders, as well as reports stored in Shared Reports Folder. You will also learn how to Schedule a report. Click the Next button start the Demonstration

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Summary Summary - You have now had the opportunity to learn how to: Navigate the eTMF Reporting Tool Run predefined Standard reports Create Flexible reports Save, print, e-mail, and schedule reports Export reports to Excel format Access Saved and Shared reports v. 1.0, 31-Mar-2008

Summary WIIFM – What’s In It For Me Improved Reconciliation - View contents across filing areas, trials, and therapeutic areas. Reconcile eTMF Documents with CTMS counterparts Better Quality & Audit Readiness - Determine easily that documents are present or missing. Oversee accuracy and consistency of document placement Track Compliance Performance – Use summary and detailed metrics to identify trends in compliance performance to SVR regulations and timelines Best Practice – Reuse, Save and schedule reports that you find useful Collaborate - Work together as a team and recommend commonly used reports to add to the Shared Reports folder v. 1.0, 31-Mar-2008

Next Steps The follow-up to this course is a series of eTMF Reporting Powercards. They provide step-by-step instructions on how to create and run Standard and Flexible reports. Flexible Report Visit Reports: Summaries, Site Detail and Workflow Responsibility Follow Up Letter Reports: Summary and Site Detail Master IMP Drug Shipment Report: Summary & Site Detail Reference Report Dashboard Report: Missing and Missing and Existing Additional Reporting Options Print, Save, E-mail, Bookmark, and Schedule Reports Request a shared Report and more… v. 1.0, 31-Mar-2008

AGORA / COGNOS Information To learn more about AGORA and COGNOS systems, use the tools provided below: CBS2-AGORA-COGNOS Navigation course on e-university https://jnj-prod.sumtotalsystems.com/sumtotal/app/management/LMS_ActDetails.aspx?UserMode=0&CallerURL=/sumtotal/app/management/LMS_LearnerHome.aspx%3FUserMode%3D0&ActivityId=102161 CBS2-AGORA Quick Start course on e-university https://jnj-prod.sumtotalsystems.com/sumtotal/app/management/LMS_ActDetails.aspx?UserMode=0&CallerURL=/sumtotal/app/management/LMS_Training.aspx%3FUserMode%3D0%26Mode%3D4%26VSC%3Dact-stdate%26VSO%3DD%26CurrentPage%3D1%26TrainingList%3D&CallerSStr=&Activity CBS2-AGORA-GCO-Consistency Checks course on e-university https://jnj-prod.sumtotalsystems.com/sumtotal/app/management/LMS_ActDetails.aspx?UserMode=0&CallerURL=/sumtotal/app/management/LMS_Training.aspx%3FUserMode%3D0%26Mode%3D2%26VSC%3Dact-stdate%26VSO%3DA%26CurrentPage%3D1%26TrainingList%3D&CallerSStr=&Activity AGORA Reference Card (AGORA Training aide) http://ctms.jjweb.jnj.com/Training/TrainingMaterialUser.asp v. 1.0, 31-Mar-2008

You have successfully completed the course Course Complete Congratulations!! You have successfully completed the course eTMF Reporting Tool Click the Close Window button to exit the course. v. 1.0, 31-Mar-2008