CTMS. Quick Reference Card. Using the CTMS Dashboard. Accessing the CTMS Dashboard. Viewing All Metrics

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Gary Reeves
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Overview The Dashboard reports key metrics about DCRI protocols. This Quick Reference Card (QRC) summarizes Dashboard operations for Project Leaders.

Accessing the Dashboard After you complete the prerequisite steps detailed in the : Preparing to Use the Dashboard QRC, you can access the online tool.

The Welcome to the Dashboard page appears.

Metric Worst Metrics Best Metrics Fastest Fallers Fastest Risers Project metrics that are furthest from targets Project metrics that are at or above targets Largest negative change in the difference

1 Overview The Dashboard reports key metrics about DCRI protocols. This Quick Reference Card (QRC) summarizes Dashboard operations for Project Leaders. All protocol names and data in this QRC are fictitious. Accessing the Dashboard After you complete the prerequisite steps detailed in the : Preparing to Use the Dashboard QRC, you can access the online tool. 1 In Internet Explorer, go to the URL provided to you from DCRI Business Support. The Dashboard Login screen appears. 2 Enter your DCRI network User ID and Password. 3 Either click OK or press Enter. The Welcome to the Dashboard page appears. Reading Project Metrics Across All Sites The All Metrics page contains the following metrics, either in block format (on the Summary tab) or in a list format (on the Metrics tab). Metric Worst Metrics Best Metrics Fastest Fallers Fastest Risers Project metrics that are furthest from targets Project metrics that are at or above targets Largest negative change in the difference between actual and target numbers from last month to this month Largest positive change in the difference between actual and target numbers from last month to this month Several icons appear on this page and throughout the website. Viewing All Metrics The All Metrics page offers an at-a-glance view of all protocols, regions, and countries so you can quickly determine those that are exceeding expectations or are in jeopardy of not meeting them. Accessing the All Metrics Page On the welcome page, click the Click here to access Protocol Metrics link. The All Metrics page appears. Icon Metric is equal to or better than the target Metric is within 10 percent of the target Metric is more than 10 percent off target Metric is experiencing an upward trend Metric is experiencing a downward trend Trend remained stable from last month to this month Comment Watchlist (adds a metric to the Home page for quicker observation) Viewing Metric History For an at-a-glance chart of a metric s history, hover your mouse over a metric link. To view a page with detailed history about an item, click its hyperlinked name. For details on how to read the information on this page, see the Viewing a Metric s History in Detail section. Printing the Information To print the information on the page, click the printer icon ( ) at the top right corner of the page. A printer-friendly version of the page appears in a new browser window. Page 1 of 5

Changing the Time Period By default, you view data for the most recent month available. To change the time period, do the following using the time selection icons near the top right area of the page.

The Time Period Selector page appears. 2 Use fields as needed to specify a different time period, and then click OK. The information in the scorecard changes accordingly.

Returning to the Welcome Page In the thin strip across the top of the screen, click the Home icon ( ).

2 Changing the Time Period By default, you view data for the most recent month available. To change the time period, do the following using the time selection icons near the top right area of the page. To change by one month at a time, click the or icon. The information in the scorecard changes accordingly. For a quick way to jump to a different time period: 1 Click the calendar icon ( ). The Time Period Selector page appears. 2 Use fields as needed to specify a different time period, and then click OK. The information in the scorecard changes accordingly. 3 To return to the most current month available, click the drop-down arrow in the time selection icons, and then select View Most Recent Values. Returning to the Welcome Page In the thin strip across the top of the screen, click the Home icon ( ). Viewing a Scorecard For a Particular Protocol, Region, or Country From the All Metrics page, you can view detailed status information (a scorecard) about a particular protocol, region, or country. Viewing a Scorecard For a Particular Protocol In the Scorecards column on the far left, click the name of a protocol. Project metrics about this protocol appear (see Reading a Scorecard ). For a Particular Region or Country In the Scorecards column on the far left, click the plus sign to the left of a protocol (do not click text) to view its associated regions and countries. Then, select a particular region or country [USA, Canada, or Rest of World (ROW)]. Project metrics about this item appear. Reading a Scorecard While in the Metrics tab, you view the following metrics in separate rows. Row Regulatory Complete Contract Executed Activated for Sites Enrolling Subject Total Regulatory Complete date Contract Executed date n Activated for date First Patient Enrolled date Sum (cumulative for each time period) of patients enrolled in the relative sites [only appears on participating sites] While in the Metrics tab, you view the following metrics in separate columns. Column Actual Target Variance Variance % Time Period Indicates the count of the specific metric Provides the projected number of the specific metric (this area is empty if you did not supply target numbers for this particular item) Shows the difference between the Actual and Target numbers Calculates the percentage of variance between the Actual and Target numbers Identifies the month where the data was pulled Note: The Target, Variance, and Variance % columns will be empty if you did not supply target numbers for the metric. Page 2 of 5

Viewing a Metric s History in Detail While you look at a scorecard (see the Viewing a Scorecard For a Particular Protocol, Region, or Country section), there are two ways to view the history of a

The chart and other information appears in a History tab.

3 Viewing a Metric s History in Detail While you look at a scorecard (see the Viewing a Scorecard For a Particular Protocol, Region, or Country section), there are two ways to view the history of a metric. For an at-a-glance chart of a metric s history, hover your mouse over a metric link. For more detailed historical information, click a metric link. The chart and other information appears in a History tab. Site-Level Detail s Regulatory Complete Includes only sites that have recorded a Regulatory Pack Sent, but have not recorded a Regulatory Complete Using the History Tab To change the time frame of the chart, click the left or right arrows located underneath the chart. To view the history in text form, click the List icon above and to the left of the chart. To provide more information for others to read, click the comment icon. To return to a previous page, click a page link in the breadcrumb at the top left of the page. Viewing Site-Level and Metric History s While you look at a scorecard (see the Viewing a Scorecard For a Particular Protocol, Region, or Country section), you can access two reports. Accessing Detailed s 1 On the Metrics tab, click a metric link. The page changes to the History tab. 2 Click the s tab. Note: If you click the s tab while you are in the Metrics tab, the s tab will be empty. You must select a specific metric first. A site-level report appears, with detailed information on sites that have not yet reached the metric you selected and do not have a Stopped or Closed status. Contract Executed Activated for Enrolling Sites Total Includes only sites that have recorded a Contract Sent but have not recorded a Contract Executed Includes only sites that have recorded a Contract Executed, but have not recorded an Activated for Includes only sites that have recorded an Activated for, but have not recorded a First Subject Enrolled For the date range selected, includes total enrollment history (status, actual, target, difference, and tolerance) per month 3 To access a report on a metric s history: a Scroll down to the Available s banner, and then click the double-arrow icon ( ) on the right end. This section expands to show available reports. The report you are currently viewing is highlighted. b Click Metric History. You view two calendars. c Click a beginning date on the left calendar and an end date on the right calendar. You can click a month without having to specify a particular day. d Click Finish. A two-page history report appears. Page 3 of 5

Capturing Information in a PDF or Excel File Although can you cannot print the information on the s tab, you can capture this data into an Adobe PDF or Microsoft Excel file.

3 Save the file to a location of your choice.

4 Capturing Information in a PDF or Excel File Although can you cannot print the information on the s tab, you can capture this data into an Adobe PDF or Microsoft Excel file. 1 Immediately above a report, click the View icon ( ). A menu appears. 2 Select either View in PDF Format or View in Excel Format. The information appears in the format you selected. 3 Save the file to a location of your choice. Adding a Metric Link to the Welcome Page To more easily keep an eye on a metric over time, you can add a metric from the s tab to the Welcome to the Dashboard page. 1 Click the appropriate metric. 2 Click the Add to Watch List icon ( ) in the upper right corner. A link to this metric now appears on the welcome page. Viewing s that Help with Estimating Two reports on the Welcome to the Dashboard page offer long-term historical information (taken from the last ten years) to help you estimate targets/ projections for future projects having similar parameters. Similar Protocols Country This information helps you project baseline and enrollment targets for new protocols. It can give you an idea of how long it might take to reach a certain. This information helps you project baseline enrollment targets by Country for new protocols. It can give you an idea of how long it may take to enroll subjects in a similar protocol. Of course, this is raw data that only summarizes past metrics. It is recommended that you work with the appropriate therapeutic area AD to discuss which past protocols would be best to use to prepare target data for a new protocol, or if you have specific questions regarding trial histories. You generate both reports in a similar way. Changing the Target Data Spreadsheet If you determine that data should be modified (examples include a Change Order with the Sponsor adding new sites or the Sponsor and DCRI agreeing to revise enrollment projections), then: 1 On the Welcome to the Dashboard page, in the Other s section, click Current Target Data Spreadsheet. A filter window appears. 2 Select the Protocol you need, and then click Finish. The spreadsheet opens in Excel. 3 Save the file in your trial folder on your computer. 4 Modify data as needed from the point the decision was made forward (not from the beginning of the trial). 5 a copy of the updated spreadsheet to DCRI Business Support dcri-ctms-business-support@dm.duke.edu. 1 On the welcome page, click the report you want. A selection criteria page appears. 2 Select criteria in the various filters. Tip: The criteria page uses smart filtering. That is, you can set one or more filters and then click the Reprompt button. The page refreshes to show only options that meet the criteria you selected so far. You can repeat this process as necessary to narrow down the list of options appearing in the large box at the bottom of the page. 3 Consider the options listed in the large box across the bottom of the page, and then do one of the following. If all protocols are valid, proceed to Step 4. If there are one or more protocols you do not want, specify the ones you do want by selecting the appropriate checkboxes. Page 4 of 5

4 Click Finish. The opens in Excel. Important! Month 1 on these reports is always the first month after the protocol s first Regulatory Packet Sent date.

2 Click Log Off. A message appears saying that you are now logged off. 3 Close the browser window or tab.

5 4 Click Finish. The opens in Excel. Important! Month 1 on these reports is always the first month after the protocol s first Regulatory Packet Sent date. Logging Off the System When it is time for you to end your session: 1 On the thin strip across the top of the screen, click the drop-down arrow to the right of Log On. A flyout menu appears. 2 Click Log Off. A message appears saying that you are now logged off. 3 Close the browser window or tab. Getting Help If you have questions or comments about the functionality of the Dashboard, DCRI Business Support at dcri-ctms-business-support@dm.duke.edu. If you experience a technical problem that you are unable to resolve, the DCRI Service Desk at dcriservicedesk@ dm.duke.edu. For time-sensitive issues, call them Monday Friday, 6 a.m. to midnight (Eastern time), at Page 5 of 5

Maryland State Department of Education and The Johns Hopkins University Center for Technology in Education

Maryland State Department of Education and The Johns Hopkins University Center for Technology in Education MD IDEA Scorecard Quick Reference Guide October 2008 GETTING STARTED: Overview The MD IDEA Scorecard