eTMF Reporting Tool 1.4

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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

Flexible Report + (Exporting to Excel)

Trial Dashboard Report (and Saving)

Visit Report – Summary Reports

Follow Up Letters - Summary Reports

Visit Reports – Site Detail + (E-mailing)

Follow Up Letters – Site Detail Reports

Visit Reports – Workflow Responsibility + (Printing)

Saved Reports (Using Master IMP Drug Shipment)

eTMF Reporting Overview

Basic Steps for Running Reports

Report Definitions

eTMF Reporting Overview

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What is eTMF Reporting?

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

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.

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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:

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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

Report Definitions

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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.

Running Reports

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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)

Flexible Report + Export to Excel

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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

Click the Next button start the Demonstration

In this demonstration, you will learn how to Run a Flexible Report, and

how to Export the report to Excel Format.

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The Visit Report - Summary Report

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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 -

Compare the visit reports in eTMF to the corresponding reports in CTMS

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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

Click the Next button start the 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

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

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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

Click the Next button start the Demonstration

In this demonstration, you will learn how to run a Visit Report – Site

Detail Report and e-mail the report.

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Visit Report – Detailed ReportsWorkflow Responsibility

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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

Click the Next button start the Demonstration

In this demonstration, you will learn how to Run a Workflow

Responsibility Report, then Print the report.

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Visit Report – Workflow Responsibility

Follow Up Letters – Summary Report

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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

Click the Next button start the Demonstration

In this demonstration, you will learn how to Run a Follow Up Letter -

Summary Report

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Follow Up Letters – Summary Report Demonstration

Follow Up Letters – Site Detail Report

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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

Click the Next button start the Demonstration

In this demonstration, you will learn how to Run a Follow Up Letter -

Site Detail Report

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Follow Up Letter Site Detail Report Demonstration

The Trial Dashboard Report + (Saving a Report)

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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

Click the Next button start the Demonstration

In this demonstration, you will learn how to Run a Trial Dashboard

Report, and how to Save a report.

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Running Previously Saved reports

v.1.1, 18-April-2008

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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

Click the Next button start the Demonstration

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.

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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://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

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Course Complete

Congratulations!! You have successfully completed the course

eTMF Reporting Tool

Click the Close Window button to exit the course.