eTMF Reporting Tool 1.4
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
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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
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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.
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eTMF Reporting 1.4 Topics
eTMF Reporting
Overview
Basic Steps for
Running Reports
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
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Report
Definitions
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
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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
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Who uses which reports?
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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
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eTMF Reporting 1.3 StartPage
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What’s In It For Me?
Below is an overview of some of the areas that the eTMF
reports address
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Report Definitions
Report Descriptions
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eTMF Reporting : Getting Started
The eTMF Reporting STARTPAGE displays descriptions for
each of the report types
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At the Top of every Visit Report and Follow Up Report is a
Report Definitions link
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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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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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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
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Running Reports
To run a report follow this typical 6 step method:
1. Select a report
2. Select Protocol, Therapeutic Area, or Compound parameters
3. Generate Regions (List updates based on selection in Step 2)
4. Select Region(s) (Optional)
5. Select Optional Parameters (selections change for each report)
6. 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)
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Flexible Report +
Export to Excel
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
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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.
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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 -

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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
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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
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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
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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
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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
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Visit Report – Workflow Responsibility
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Follow Up Letters – Summary Report
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)
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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
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Follow Up Letters – Summary Report
Demonstration
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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
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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
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Follow Up Letter Site Detail Report
Demonstration
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The Trial Dashboard Report
+ (Saving a Report)
The Trial Dashboard 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
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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
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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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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My Folders
 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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Shared Reports
 eTMF – Shared Reports are stored in a folder link on the
Public Folders tab
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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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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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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
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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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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…
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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://jnjprod.sumtotalsystems.com/sumtotal/app/management/LMS_ActDetails.aspx?UserMode=0&Caller
URL=/sumtotal/app/management/LMS_LearnerHome.aspx%3FUserMode%3D0&ActivityId=10216
1
- CBS2-AGORA Quick Start course on e-university
-
https://jnjprod.sumtotalsystems.com/sumtotal/app/management/LMS_ActDetails.aspx?UserMode=0&Caller
URL=/sumtotal/app/management/LMS_Training.aspx%3FUserMode%3D0%26Mode%3D4%26VS
C%3Dact-stdate%26VSO%3DD%26CurrentPage%3D1%26TrainingList%3D&CallerSStr=&Activity
- CBS2-AGORA-GCO-Consistency Checks course on e-university
-
https://jnjprod.sumtotalsystems.com/sumtotal/app/management/LMS_ActDetails.aspx?UserMode=0&Caller
URL=/sumtotal/app/management/LMS_Training.aspx%3FUserMode%3D0%26Mode%3D2%26VS
C%3Dact-stdate%26VSO%3DA%26CurrentPage%3D1%26TrainingList%3D&CallerSStr=&Activity
- AGORA Reference Card (AGORA Training aide)
-
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http://ctms.jjweb.jnj.com/Training/TrainingMaterialUser.asp
Course Complete
Congratulations!!
You have successfully completed the course
eTMF Reporting Tool
Click the Close Window button
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to exit the course.