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

2. 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:

3. 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, , and schedule reports
Export reports to Excel format

4. 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.

5. 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
+ ( ing)
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

6. eTMF Reporting Overview

7. 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

8. 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

9. Who uses which reports?

10. Access to eTMF Reporting Tool
Links to access the eTMF Reporting Tool are available at several locations:
Every page on the eTMF website
also
GCO Portal Home page

11. eTMF Reporting 1.3 StartPage

12. What’s In It For Me?
Below is an overview of some of the areas that the eTMF reports address
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13. Report Definitions

14. Report Descriptions

15. 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

16. At the Top of every Visit Report and Follow Up Report is a Report Definitions link
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17. 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.
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18. 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.
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19. Running Reports

20. 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

21. 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)

22. Flexible Report + Export to Excel

23. The Flexible Report Flexible Report
Flexible Report– Informed Consent
Use Choose a different Protocol Search Method
Compound:
Generate the Protocols and Regions for the selections made above
Protocol: MMY3021
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/, 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
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24. 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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26. The Visit Report - Summary Report

27. 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.

28. 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

29. 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
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30. 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

31. 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
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32. Visit Report - Site Detail Report + e-Mailing the Report

33. 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
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34. Visit Report – Site Detail Demonstration
In this demonstration, you will learn how to run a Visit Report – Site Detail Report and the report.
Click the Next button start the Demonstration

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36. Visit Report – Detailed Reports Workflow Responsibility

37. 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
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38. 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

39. Visit Report – Workflow Responsibility
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40. Follow Up Letters – Summary Report

41. 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)
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42. 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

43. Follow Up Letters – Summary Report Demonstration
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44. Follow Up Letters – Site Detail Report

45. 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
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46. 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

47. Follow Up Letter Site Detail Report Demonstration
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48. The Trial Dashboard Report + (Saving a Report)

49. 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 – Keep this version – Report, include link and attach report
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50. 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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52. Running Previously Saved reports
v.1.1, 18-April-2008
v. 1.0, 31-Mar-2008

53. 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
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54. 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
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55. 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:
Protocol Status: In Progress
Click Generate Protocols & Regions
Protocol: MMY3021
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
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56. Shared Reports
Run this Drug Shipment Report Previously saved.
CREATE THIS REPORT IN ADVANCE
Master IMP Drug Shipment Report
Compound:
Protocol Status: In Progress
Click Generate Protocols & Regions
Protocol: MMY3021
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
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57. 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:
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58. 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
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59. 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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61. 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, , and schedule reports
Export reports to Excel format
Access Saved and Shared reports
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62. 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
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63. 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, , Bookmark, and Schedule Reports
Request a shared Report and more…
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64. AGORA / COGNOS Information
To learn more about AGORA and COGNOS systems, use the tools provided below:
CBS2-AGORA-COGNOS Navigation course on e-university
CBS2-AGORA Quick Start course on e-university
CBS2-AGORA-GCO-Consistency Checks course on e-university
AGORA Reference Card (AGORA Training aide)
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65. 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.
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