CPAC Training for Site Personnel REV 5.00

Overview

This course discusses how to use all CPAC functionalities.

CPAC Training for Site Personnel Rev 5.00

Overview

Welcome to the CPAC Training for Site Personnel Rev 5.00 training course. This is an updated course that applies to CPAC V7.8, released in May 2016.

This course will take approximately 45 minutes to complete.

About this course...

This course will help to ensure you understand how to use all CPAC functionalities and perform tasks for which you may be responsible.

To receive course credit, you must follow the steps on the Course Completion page.

Each chapter is a demonstration of a CPAC task for which you may be responsible.

Introduction to CPAC

This chapter discusses the purpose of CPAC.

Summarizes Information

Dr. Jane Smith is a Primary Investigator (PI) working on a clinical trial. Her Clinical Research Associate (CRA) informed her that the study will use a web-based Clinical Portal and Collaboration tool, known as CPAC.

CPAC provides a summary of trial, country and site enrollment information, and planned and actual dates for important milestones, such as First Subject First Visit and Site Ready.

Access to Resources

Dr. Smith can access study documents, such as the protocol, submit and update financial disclosure information, and access the Electronic Data Capture (EDC) tool and additional study resources. She can also acknowledge and access IND Safety Reports.

In this course, Dr. Smith will learn how to use CPAC to view study related information and complete tasks needed to conduct a clinical trial.

Logging into CPAC

CPAC is a web-based tool. Dr. Smith is going to launch her internet browser and log into CPAC.

Note: CPAC is compatible with Internet Explorer, Google Chrome, Apple Safari, and Mozilla Firefox.

Use the following site to access CPAC:

US users can go to <a href="http://www.mercktrials.com/" class="bookmark">www.mercktrials.comwww.mercktrials.com</a>
International users can go to <a href="http://www.msdtrials.com/" class="bookmark">www.msdtrials.comwww.msdtrials.com</a>

To log into CPAC, Dr. Smith will use the User ID and password she created using the Password Management Application.

CPAC Home Page

CPAC opens and displays the CPAC Home page.

Note: Instructions for using the Password Management Application are covered in the CPAC Help. You would click the CPAC Help button and navigate to Unit 1, topic titled “Access and Password Information” to view and/or print these instructions.

Exploring CPAC

This chapter discusses how to access information in CPAC.

Access and Functions

In this chapter, Dr. Smith explores how to access information about her sites and how to use the CPAC functions.

The CPAC Home page is the first page you see after you log in to CPAC. It provides access to three types of information for the studies in which you are participating. We will look at each area in more detail on the following pages as Dr. Smith navigates through each CPAC section to view her information.

Click on each button to learn more about three important sections of the CPAC Home page.

Trial, Country, and Site Selector

This section allows you to select a specific trial, country, and site. Your selections control the information that displays on other CPAC pages that are accessed using the tabs across the top of the Home page.

Announcements

This section displays important CPAC announcement and new tasks and announcements for your studies.

Enrollment Status

This section provides enrollment status for the trials/countries/sites to which you are assigned.

Trial-Country-Site Selector

The Trial-Country-Site Selector controls the information that displays on other CPAC pages that are accessed using the tabs across the top of the Home page.

Using the tabs, Dr. Smith can:

Navigate back to the Home page
View financial disclosure alerts
Collaborate by viewing announcements, survey, links, and tasks
View contact information
Complete financial disclosure information
Access IND Safety Reports (US only)
View study milestones
Access study documents

Viewing Milestones

For example, Dr. Smith would like to view milestones for site 0431-063-0004 in the United States.

Using the Trial-Country-Site Selector, Dr. Smith would choose each option from the list, click the Go button, and then click the Milestones tab.

Milestones

If you had not already selected your trial, country, and site from the Home page, the Milestones page would be empty. You would use the Trial-Country-Site Selector to make your selections to view milestones for the trial, country, and site selected.

Using the selector, you can control which milestones are displayed. You may select any of the following:

Select only a trial and click the Go button to see only trial milestones for a specific trial.
Select a trial and country and click the Go button to see trial and country milestones for a specific trial.
Select a trial, country, and site and click the Go button to see trial, country and site milestones for a specific trial.

Note: After selecting a trial it may take a few seconds for the Country drop down picklist to refresh. Then, after selecting a country it may take a few seconds for the Site drop down picklist to refresh.

Milestone Sections

Milestones for 0431-063-0004 display on this page in three different sections:

Trial Milestone
County Milestone
Site Milestone

Announcements

The Announcements section displays global news or updates, such as CPAC outages or downtime information, requests to complete surveys, and company related news items.

What’s New for You

What’s New for You displays new trial or country specific announcements and trial, country, or site specific tasks that have not been addressed.

When a new trial or country announcement is posted on CPAC, or a new task is assigned to Dr. Smith, she will also receive an e-mail alert.

Assignments

You will help Dr. Smith check to see if she has any announcements or tasks assigned to her.

You would click the arrow next to 0431-063 to see announcements or tasks assigned to Dr. Smith.

As you can see, Dr. Smith has three tasks and two announcements assigned to her. If she does not have any new announcements or tasks this section will be blank.

Clicking the arrow again will collapse the list.

Enrollment Status

The Enrollment Status section displays the enrollment status of all sponsor trials to which Dr. Smith is assigned.

Trial, country, or site enrollment data can be displayed depending on the view selected from the Enrollment Status View Selector.

Sort Column Headers

Please note: Your version of CPAC:

Has column headers on which you can sort, as indicated by the blue underlined text in this image.
Includes an additional column header — Lead Site Monitor.

The other images in this demo do not show these two features. Otherwise this demo looks the same as your version of CPAC will look.

Enrollment Status View Selector

The Enrollment Status View Selector controls what you see below under Enrollment Status. Dr. Smith can view enrollment status by three different ways:

My Trials
My Countries
My Sites

Trial Rows

The CPAC Home page initially defaults to the My Trials view and displays trial enrollment totals for all trials to which Dr. Smith is assigned.

Dr. Smith can expand a trial row to see the enrollment totals for all the countries participating in a trial.

Clicking on the dropdown button from the first trial in the list, 0431-063, will expand the row for Dr. Smith.

Access Indicators

Now Dr. Smith can see the enrollment totals for each country participating in this trial.

Notice the green and red Access indicators. The country to which Dr. Smith has access shows a green indicator. Those countries to which Dr. Smith does not have access show red indicators.

Country Rows

Dr. Smith can expand a country row to see the enrollment status for all sites in the country from which she is working.

Clicking on the dropdown button from the first country in the list, United States, will expand the row for Dr. Smith.

Now Dr. Smith can see the enrollment status for all sites in the country from which she is working.

Again, notice the green and red Access indicators. Sites to which Dr. Smith has access show green indicators. Those sites to which Dr. Smith does not have access show red indicators.

Enrollment Status Column Headers

Let us take a look at the Enrollment Status section in more detail. Click on each button to learn about the Enrollment Status column headers.

EDC Access

Clicking on the EDC (Electronic Data Capture) Access icon allows access to EDC InFormTM for that trial.

Screened

<ul> <li>Screened: Number of subjects who have been screened at the site</li> <li>Latest Estimate: Number of subjects that were planned to be screened at the site</li> <li>PTD (Planned To Date): Number of subjects that were planned to be screened by the current date at the site</li> <li>Actual: Number of subjects screened at the current date at the site</li> <li>SFR (Site Failure Rate): Screen failure rate at the site</li> </ul>

Randomized/Treated

<ul> <li>Randomized/Treated: Number of patients that have been randomized/treated at the site</li> <li>Planned: Original number of subjects planned to be randomized at the site</li> <li>Latest Estimate: Current number of subjects planned to be randomized at the site</li> <li>PTD (Planned To Date): Number of subjects planned to be randomized at the site by the current date</li> <li>Actual: Number of subjects randomized/treated at the site at the current date</li> <li>WR (Withdrawal Rate): Withdrawal rate at the site</li> </ul>

Hide and Unhide Buttons

The Hide Selected and Unhide Selected buttons are useful for users with numerous trials listed on the Enrollment Status table. Click on each button to learn more.

Hide selected

Select the checkbox to the left of a trial that is no longer active and you wish to hide and then click this button. The color of the trial row will change to gray and move to the bottom of the trial listing.

Unhide selected

Select the checkbox to the left of a trial you wish to unhide and then click this button. The trial is returned it to its original position in the trial listing.

My Config

As was mentioned, CPAC initially defaults to the My Trials view for enrollment status. It is possible to change the default view to either My Countries or My Sites, and save this change so that future CPAC logins retain this new view.

You would use the My Config link in the upper right corner to change and save your view.

Changing Views

Dr. Smith would prefer to always view the enrollment status for her sites. However, when using the My Sites view, she cannot see enrollment totals for a trial or country, or enrollment status for other countries and sites.

To change Dr. Smith’s default view, she would first click the My Config link. From the My Config Setting dialogue box, she would click the drop down arrow and select My Sites, then click the Submit button.

The new view setting has now been saved. The next time Dr. Smith logs in to CPAC, her Home page will display the My Sites view.

Clicking on the close button will close the My Config dialogue box.

Password Tips

Users can view information about various systems access and password processes being used. Systems included on the Password Tips Information page are CPAC, External MyLearning, InForm 4.6 and InForm 6.1.

Help Button

In the upper right corner of every CPAC page is a Help button, which is your link to online help that you can access whenever you need CPAC-specific information or instructions.

Dr. Smith wants to access the CPAC online help. Clicking on the question mark in the upper right will allow access to the CPAC online help.

CPAC Help

The CPAC Help is divided into two chapters: help topics specific for external CPAC users, and help topics specific to sponsor CPAC users.

Clicking on the External Site Management View chapter allows you to see examples of help topics that are available to you.

You can quickly navigate topics of interest to you. Clicking the close button (the red X in the upper right-hand corner of the screen) closes the CPAC online help and returns you to CPAC.

Logging Out

When Dr. Smith is done using CPAC, she must log out. To log out of CPAC, Dr. Smith would click on the Welcome Dr. Jane Smith link in the upper right corner, and then click Sign Out.

Summary

In this chapter, Dr. Smith navigated through different sections of the CPAC Home page. When using CPAC to view information about her sites, Dr. Smith will use the Trials-Country-Site Selector to select a particular site and then use the tabs across the top of the Home page to view information related to that site. In the next chapter, Dr. Smith will further explore how to access site specific information.

Managing Trial Site Information

This chapter discusses how to manage trial site information.

Accessing Trial Site Information

In this chapter, Dr. Smith will access trial site information for the trials in which she is participating. She will explore announcements, links, surveys, tasks, contact information, milestones, and training statuses for site staff.

Trial-Country-Site Selector

To access trial site information, Dr. Smith would use the tabs across the top of the Home page. However, she would first make selections using the Trials-Country-Site Selector and then click on the Go button.

Note: After selecting a trial it may take a few seconds for the Country drop down picklist to refresh. Then, after selecting a country it may take a few seconds for the Site drop down picklist to refresh.

Collaboration Tab

After making her selections, the information displayed on the pages for the tabs across the top of the Home page will be specific to this trial, country and site.

Let us begin by looking at the trial site information that is available from the Collaboration tab, which contains a submenu of four options:

Announcements
Links
Surveys
Tasks

Dr. Smith will begin by looking at Announcements, which she may access from the Collaboration tab’s submenu by one of two methods.

Methods

Method 1: Dr. Smith could hover her mouse over the Collaboration tab to display the submenu, and then select the Announcements submenu option to display the Announcements page.

After clicking the Announcements submenu option, the Announcements page displays.

Method 2: Dr. Smith could click the Collaboration tab to display the submenu. The default page that displays is the first submenu option on that tab, in this case, the Announcements page.

Note: A tab’s default page is the page related to the first submenu option on that tab. In this example, Announcements is the default page as it is the first submenu option on the Collaboration tab.

The Announcements page contains global announcements, such as general CPAC announcements or sponsor-related announcements that apply to all trials.

Trial Announcements and Country Announcements

This page also displays Trial Announcements and Country Announcements. Dr. Smith will receive an e-mail when a new trial or country announcement is posted. E-mail alerts are not sent for global announcements.

Notice the shading of announcements rows:

A white row indicates the announcement has not been read.
A gray row indicates the announcement has been read. There is a checkmark under the Mark As Read column, which also indicates the announcement has been read.

Reading Announcements

If Dr. Smith wants to read the first announcement, she would begin by clicking on the announcement title to open the announcement and read the details.

After reading the details, Dr. Smith would click the Close button to return to the Announcements page.

Mark As Read

The first announcement row is now shaded gray and the Mark As Read checkbox is checked.

If Dr. Smith would like to see announcements for another trial in which she is participating, she would make her selections from the Trials-Country-Site Selector and click the Go button to select the other trial and see any announcements for that trial.

Links

Next, Dr. Smith will view the Links page. Clicking on the Links title from the submenu will open the Links page.

The Links page displays links to resources for your:

Trial, such as trial-related vendor web sites and other sponsor sites you may need to access.
Country, such as country-specific vendor sites.

Clicking a link opens the resource in a new window. Notice that some links are followed by Sponsor Users Only, which indicates these links cannot be accessed by non-Sponsor users.

Notice that the page automatically displayed links for the trials and country Dr. Smith had previously selected to view her announcements. Using the Trial-Country-Site Selector, she can select a different trial and country and click the Go button at any time.

Surveys

Now Dr. Smith will view the Surveys page. Clicking on the Surveys title from the submenu will open the Surveys page.

The Surveys page displays links to surveys which you are expected to complete. Dr. Smith would now like to complete the CPAC Usability Survey, the second survey in the list. To start Dr. Smith would click the title of the survey.

Responding To Surveys

To open the survey, you would click the Respond to this Survey button.

To complete a survey, you would:

Answer each question.
Add any comments.
Click the Finish button.

Tasks

Finally, you will help Dr. Smith complete a task. To start, Dr. Smith would click Tasks from the submenu.

Tasks may be specific to a trial, to everyone working in the same country for a trial, or to a site.

Edit Item

Dr. Smith received an e-mail that she has a new task to address. This task is a site task sent by Dr. Smith’s CRA requesting Dr. Smith to upload her CV.

Let us assume Dr. Smith has uploaded her CV. Dr. Smith will now mark this task as completed. To do this Dr. Smith would click the title of the task.

In the new window that opens, Dr. Smith would then click the Edit Item button.

Mark Task as Completed

Dr. Smith now needs to mark this task as completed. To do this she would click the drop down arrow of the Status field and select Completed.

In Progress

If needed, Dr. Smith could attach a file. Refer to the CPAC training manual for instructions on how to attach a file.

If Dr. Smith wanted to notify the CRA that she is working on this task, Dr. Smith would select In Progress from the drop down picklist and then enter a number percentage in the % Complete field.

When Dr. Smith is finished making adjustments, she would click the Save button.

Completed Tasks

After a task is marked as Completed, the originator of the task receives an e-mail stating the task has been completed.

Contacts

Let us take a look at the Contacts tab.

Dr. Smith is primarily interesting in contacts for her site. She can also see sponsor contact information, as well as trial and country contacts. Contact phone numbers, fax numbers, and e-mail addresses will be available in the actual CPAC application. These e-mail links can be used to send non-secure e-mails.

Milestones Page

The next tab Dr. Smith will explore is the Milestone tab.

The Milestones page displays trials, country, and site milestones and respective planned and actual dates for these milestones for Dr. Smith’s trial.

Click on each button to learn about the Event Type, Latest Estimate, and Actual columns.

Event Type

Event Type is the name of the milestone.

Latest Estimate

Latest Estimate is the date the milestone is/was expected to occur.

Actual

Actual Date is the date the event occurred.

Note: If Actual Date is blank this indicates the milestone has not yet been achieved.

Site Milestones

Dr. Smith is primarily interested in the event dates for her site. She can review the latest estimate dates for her site and ensure that the milestones she is responsible for are met on time.

Other Tabs

The Financial Disclosure, IND Safety Reports, and Study Documents tabs will be explored in other chapters in this course.

Summary

In this chapter, Dr. Smith reviewed how to access and act on information about her trials, including viewing announcements, resource links, contacts, milestones, and training statuses, and completing surveys and tasks.

Working With the CPAC Document Library

This chapter discusses accessing and working in the document library.

Study Documents

In this chapter, Dr. Smith will access trial, country, and site specific documents from the CPAC Library using the Study Documents tab from the CPAC Home page.

To access the document library from the Home page, you would make your trial, country, and site selections and click the Go button, then click the Study Documents tab.

Trial-Country-Site Selector

If you had not already selected your site, you would use the Trial-Country-Site Selector and select the site you need to work with before accessing documents in the library.

Using the selector, you can control which documents are displayed in the library. You may select any of the following:

Select only a trial and click the Go button to see trial level documents for a specific trial.
Select a trial and country and click the Go button to see trial and country level documents for a specific trial.
Select a trial, country, and site and click the Go button to see trial, country, and site level documents for a specific trial.

Library Page

The Library page contains Study Documents section.

The Study Documents section displays approved essential and non-essential documents for the trial, trial country, and/or trial site selected. The Study Documents section displays documents surfacing from the sponsor’s electronic Trial Master File, including Protocol, Protocol Amendments, and Investigator Brochure.

Study Documents

Let us take a look at the Study Documents section in more detail. After making your selections from the Trial-Country-Site Selector, Study Documents displays ALL documents relative to your selections.

The listing of study documents may be filtered by Document Subtype or Document Classification. Documents may be sorted by any column. An arrow indicates on which column the contents were sorted. In this example, contents were sorted by date, as indicated by the arrow in the Document Status Data column.

Study Documents section only displays 20 documents per page. Use the Previous and Next arrows to page through the document. Also, in the text book next to the magnify glass, Dr. Smith can search for specific documents by typing in keywords, or a letter or number that may be part of a document title or file name, and hitting Enter on the keyboard.

Column Headers

Click on each button to learn about each column header area.

Name

This column displays the title of the document.

Document Status Date

This column shows the date when the latest status of the document changed (Approved Date).

Comments

Any comments entered for the document when it was placed in our electronic Trial Master File can be found in this column.

Issue Date

This column shows the date the document was issued.

Document Status

A document status displays as “Approved”. Only Approved Documents are displayed.

Summary

In this chapter, Dr. Smith viewed the contents of the CPAC Library.

Submitting Financial Disclosure Information

This chapter discusses how to submit financial disclosure information.

Financial Disclosures

In this chapter, Dr. Smith will address a Financial Disclosure alert and fill out the Financial Disclosure information.

Note: The Primary Investigator and Sub-Investigators completing Financial Disclosure information via CPAC will be asked to electronically-sign (e-sign) the information being submitted. Before e-signing the Financial Disclosure information, the Clinical Investigator will be presented information on the sponsor e-signature policy. The Clinical Investigator will need to review and accept his/her understanding of this policy before e-signing the financial disclosure related data.

Alerts

The Clinical Investigator will see any financial disclosure alerts for his or her studies by clicking the Alerts tab at the top of the page.

Financial Disclosure alerts are important notices that require attention. Financial Disclosure alerts appear whenever there is action required regarding the status of a Clinical Investigator’s Financial Disclosure information. CPAC displays all active alerts as a default. If you are working on multiple studies, you can use the Trials-Country-Site Selector to view alerts for a specific study. You must select a value for each item for the filter to process correctly.

Alert Icons

A red exclamation point appears when there is a new alert to be addressed.

A blue information icon would appear in the second column when there is updated information about the alert.

Alert Types

The Alert Type column indicates the type of alert. There are three different types of Financial Disclosure alerts that a Clinical Investigator may receive.

Click on each button to learn more.

Initial

An Initial alert is received when there is a new request for an investigator to complete and submit Financial Disclosure information.

Update

An Update alert indicates a request for ‘End of Study’ or ‘End of Study + 1Yr’ financial information.

Overdue

An Overdue alert is received when 45 days have passed since an Initial alert was received and no Financial Disclosure information has been submitted.

Dismissing Alerts

This is an Overdue alert for Dr. Smith. Dr. Smith should complete Financial Disclosure information before dismissing this alert.

After completing the Financial Disclosure information, Dr. Smith will return to this page and click Dismiss to manually dismiss the alert. Once an alert is dismissed, it is no longer displayed in the default view. A dismissed alert can be viewed by selecting Dismissed or All from the status drop down menu.

Financial Disclosures

To complete Financial Disclosure information, Dr. Smith would click the Financial Disclosure tab.

Financial Disclosure Scenarios

There are three different scenarios for submitting Financial Disclosure information. Click on each button to learn more.

CURRENT Reports

This section displays CPAC trials with an Initial request for Financial Disclosure information. The Status column may have a status of Missing, Pending, or Approved.

The Action column displays either a: <ul> <li>Create link for reports with a Missing status. To submit Financial Disclosure information, click the Create link and follow the instructions.</li> <li>View link for reports with an Approved or Pending status.</li> </ul>

OVERDUE Reports

This section displays CPAC trials for which the Financial Disclosure information was requested more than 45 days ago. The Status column will have a status of Missing.

The Action column displays a Create link. To submit Financial Disclosure information, click the Create link and follow the instructions.

UPDATE Reports

This section displays CPAC trials for which updates may be needed to the Financial Disclosure information. Clinical Investigators are asked to update their information at least once during the study. This information can be updated as often as is needed. The Status column will have a status of Approved or Pending to show previously submitted information has been received or is in the process of being reviewed.

The Action column displays an Update link. To submit Financial Disclosure information, click the Update link and follow the instructions.

Submitting Overdue Information

Next, Dr. Smith will submit overdue Financial Disclosure information. From the Overdue Reports section, under the Action column, Dr. Smith will click the Create link and follow the instructions to submit Financial Disclosure information.

Financial Disclosure Page

This Financial Disclosure page contains three sections of information. Click on each button to learn more.

Financial Disclosure Information

This section displays disclosure instructions and personal profile information. This section also displays instructions for updating profile information, the session timeout policy, and places to enter or update telephone and fax numbers. Notice that the telephone field has an asterisk after it. An asterisk indicates a required field. To satisfy Financial Disclosure information requirements, Dr. Smith must supply her telephone number.

Questionnaire

This section displays five financial disclosure questions that the Clinical Investigator needs to answer.

Financial Disclosure Submission

This section displays e-signature policy information, a place to enter user’s credentials to e-sign the Financial Disclosure information being submitted, and a link to submit the data.

Updating Financial Disclosure Information

To begin updating her Financial Disclosure information, Dr. Smith must first verify information displayed in the Financial Disclosure information section. For this example, let us assume Dr. Smith added her telephone number, and verified or corrected all other information, as needed. Dr. Smith may now go to the Questionnaire section.

Questionnaire

Now Dr. Smith will need to answer these five questions. For some questions, selecting Yes reveals instructions asking you to supply additional information.

For example, let’s say Dr. Smith selects Yes for Question 1. Notice that additional information displays. Dr. Smith would enter any needed information and comments related to this question.

Questionnaire

For this example, let us assume that no information needs to be changed. Questions 1 through 5 answers may remain as “No.”

Once “No” is selected for all questions, Dr. Smith may now go to the Financial Disclosure Submission section.

Financial Disclosure Submission

Dr. Smith would first review the e-signature policy information and then select the ACCEPT checkbox to acknowledge she has reviewed and understands the information provided. For this example, let us assume Dr. Smith reviewed the policy. She would then select the ACCEPT checkbox.

Next, Dr. Smith would select the Reason checkbox and e-sign the information using her CPAC User ID and Password. Then Dr. Smith would click the Submit link to submit this information.

Report Details

If needed, Dr. Smith may print this page, or print this page as a PDF and store on a local computer. Remember, after submitting Financial Disclosure information, it is important to return to the Alerts page and “dismiss” the Financial Disclosure alert.

Dismiss Disclosure

Clicking on the Alerts tab will navigate back to the Alerts page and allow you to “dismiss” the Financial Disclosure alert.

Clicking Dismiss will manually dismiss the Financial Disclosure alert for Dr. Smith.

Summary

In this chapter, Dr. Smith addressed a Financial Disclosure alert and filled out and submitted the Financial Disclosure information.

Completion

This chapter completes this course.

Completion

Congratulations, you have completed this course. Click on the button below to receive credit for this course.

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