Managing Studies

The next step in Clinical Basics: eTMF administration is creating and managing studies. After you create a Study, you will use the main study window to enter additional information about the study:

  • Personnel
  • Product
  • Country
  • Site
  1. To create a study, navigate to Create > Study.
  2. Enter the number of your study and any additional information. Highlighted fields are required.
  3. Click Save. The system now displays the main window for your new study.

Adding Products to Studies

  1. Navigate to Study Products > Create to display the Study Product section. Active products automatically display in the Product dropdown list displays:
    • If it is included in the list, select the desired product.
    • If it is not included in the list, click Create Product and enter the appropriate information in the pop-up window. Click Save. The system populates the Product name as well as the list of active Study product roles.

Adding Sites to Studies

  1. Use the breadcrumbs to navigate back to the main study window.
  2. Click Create under the Study Countries section to access a list of countries.
  3. Select the appropriate country from the list, and click Save.
  4. Click Create under the Study Sites section. The system displays a Details page.
  5. Enter the Study Site Number.
  6. (Optional) While in this section, you can also enter information for the Organization and the Primary Location. In both cases, you can select from a drop-down list or create a new entry. For any item you create, you must complete the highlighted fields before saving.
  7. Click Save. Your site is now complete and ready to be assigned to personnel.

Adding Personnel to Sites

Upon completing the site set-up, the system prompts you to add a principal investigator and a sub investigator to your study site.

  1. Navigate to Study Site Personnel and click Create.
  2. Ensure that the Person Type selected is investigator by filtering the Global Directory list:
    • Click the binoculars on the Person field to display the advanced search, which includes all of the personnel records in the Global Directory.
    • Filter by Person Type to show the list of Investigators only.
  3. (Optional) If the correct person is not in the Investigators list, click Create to enter a new investigator in the Global Directory.
    • Select Investigator as the person type and click Continue.
    • Type the last name and email to create a contact information record.

  4. Click Save, and the investigator along with their contact information will be added to the global directories and associated with the study site.

  5. Select Principal Investigator as the Study Team Role.
  6. (Optional) Add start and end dates to indicate when the person began working on the study when they left or finished working on the study.
  7. Select the new person in the Primary Contact Information to include their information on the study site.
  8. Click Save. Refresh the screen to display the newly added Principal Investigator.
  9. Repeat steps 1 - 8 to add subinvestigators and other site staff.

Setting Milestones and Metrics

In CTMS, after the study is built, you have the option of setting up a planned timeline and metrics to begin setting up for site visits.

  1. Click Milestones. The system displays a prepopulated list of expected activities.
  2. Based on your plans, enter expected finish dates for each activity.
  3. Click Metrics. The system displays a prepopulated list of expected metrics.
  4. Based on your plans, enter expected values for each metric. The actual values for all items in the study timeline will automatically populate as you execute your study.

Setting Visit Definitions

In addition to milestones and metrics, you can set visit definitions for CTMS studies. These definitions determine what types of visits you anticipate for each study, such as an initial visit or a 30-day follow-up.

  1. Click Visit Definitions.
  2. Click Create. The system prompts you to type in a Name, Description and Sequence for the proposed Visit Definition.
  3. Click Save to add it to the list of visits in your Monitoring Plan.