Summary

This article covers how to configure the visit schedule.

Table of Contents

EDC patient visit information can be brought into the CTMS environment to create a Patient Visit Schedule Report as well as capture patient details and progress which can be utilized to trigger payments and track enrollment. The Visit Schedule screen is where a user can define what EDC patient visit data should be brought into the CTMS study environment.

Once a study team has configured Visit Schedule, the information is brought in at the Study Site level, on the Patient Screen. The information on the Study Site, Patient screen can be populated through one of 4 ways:

  1. Connected to Fountayn’s EDC with real-time population of the Study Site Patient Screen
  2. Utilizing APIs to connect to a non-Fountayn EDC, populating data into the Study Site Patient Screen (schedule arranged between study team and EDC provider)
  3. Manually adding patient information on the Study Site Patient Screen (non-Fountayn studies only)
  4. Utilizing the Import Manager to import patient information into the Study Site Patient Screen (non-Fountayn studies only)

Taking time to properly populate the Visit Schedule screen is crucial as the patient visit data brought into the Study Site Patient screen is utilized in the following areas:

  • Clinical Plan > Project Planning: To define the Patient Status (Screened, Randomized, etc.) to collect and report on patient enrollment at the study level.
  • Study Site > Patient Form: Gather data that is helpful in the analysis of study progress and success.
  • Study Site > Site Enrollment: To identify the site’s enrollment and current patient statuses (Screened, Randomized, etc.), which also assists in the generation of the Enrollment Report.
  • Study Site > Site Budget: The Visit Data populated on the Visit Schedule will also appear for the Site Budget form to define monetary values for the data collected based on the site budget for the study.
  • Standard Reports > Patient Visit Schedule Report: The expected date ranges can be defined to populate the Patient Visit Schedule Report.

 

Access Visit Schedule Form

The Visit Schedule form for existing studies can be access by selecting Visit Schedule under the Clinical Plans sub-menu for the study.

 

By default the Visit Schedule form is blank for a new study.


Access Add Visit Data

The Add Visit Data form can be accessed by clicking Add Visit Data found in the Actions Menu on the Visit Schedule form.


Add Visit Data

With this process, users will identify each piece of patient visit data they would like to capture in the CTMS study. CTMS walks users through some of the expected initial data points by automatically programming the first few entries as:

  • Primary Identifier (required to create the patient record)
  • Secondary Identifier (required to avoid the duplication of records)

Following these 2 identifier fields, the system will automatically select Date as the next Visit Data’s Data Type. This is to assist in the process of building the expected patient visit schedule as designed in the study’s EDC. Users can choose whether to first build the expected patient visit schedule (Data Type: Date) or to change the Data Type to “Question” and identify EDC data to bring into the CTMS study that is NOT a part of the Visit Schedule Report.

The Add Visit Data form contains the following fields by default:

 

Question Text Field

The Question Text is a text field used to identify the question name as it appears on the form. By default, the Question Text field is a required field and a black alert will fire if the question text is not provided. The form cannot be saved until the question text data is entered.

Question Header Field

The Question Header is a text field used to identify the text label for the question in ad-hoc reports. By default, the Question Header field is a required field and a black alert will fire if the question header is not provided. The form cannot be saved until the question header data is entered.

Data Type Field

The Data Type field is a dropdown field used to identify the type of question. By default options are:

  • Primary Identifier: Used as the primary identifier for the patient on the Patient screen and patient reports.
  • Secondary Identifier: Used as the secondary identifier for the patient on the Patient screen and patient reports.
  • Date: Should only be selected for dates that comprise the Visit Schedule report. When this type is selected, the data is included in the Visit Schedule Report.
  • Question: Users should utilize this type when bringing in any EDC patient visit data that is NOT a date that is part of the patient visit schedule (site number, DOB, AE questions, form completion questions, etc.).
  • Patient Status Label Field: The study team can choose specific EDC fields to represent the achievement of a patient status. To trigger a status, CTMS does not consider the EDC question’s answer value, but the presence of data in the question’s answer field. The Patient Status Label is a text field used to identify the question as an indicator that the patient has met a status (Screened, Randomized, etc.). For example, if desired, the presence of data in the casebook’s Visit One Date field could represent the Screened patient status.
    • Patient status is utilized in the following areas:
      • Identify recruitment numbers on reports.
      • Project Plan form
      • Site Enrollment form.


Note: If a Patient Status label is provided for a dynamic EDC Connection field the first dynamic occurrence will count towards the status.



  • EDC Connection(Fountayn EDC-connected studies only): A CTMS study that is linked to a Fountayn EDC study can connect a newly created Data Visit field with the related EDC casebook field. Once the Visit Schedule is activated and the related EDC field is completed within a patient casebook, the answer value from the Fountayn EDC will be populated real-time in the appropriate Study Site Patient screen.
    • The EDC Connection field is a Choose Question field. When selected, the Select Desired Question dialog will appear. The Select Desired Question dialog will display the form/question structure for the connected study. To connect the EDC and CTMS questions, click the question text. The trial must have a loaded XML (Data Architect) version loaded to Production (or Approve if in the approve environment) in Trial Manager to get the Select Desired Question dialog to appear. Recommendation is to build out the Visit Schedule for a study during the start-up, activate it to reference the Status in CTMS and then come back and link to EDC once the trial is designed and loaded to Production in Trial Manager.
    • The connected question cannot be on a reference data type question.
    • The connected question can be on a dynamic form (forms that could have 0-unlimited instances, such as Medical History, Concomitant Medications, Adverse Events, etc). The Patient form shall display the recurring question based on the highest occurrence of that form in the entire linked study. For example: If the Adverse Event (AE) field on the Adverse Event form (dynamic) is linked to a Visit Data field and Patient A had 10 AE forms, all patient screens will display 10 AE fields, with unnecessary ones remaining empty.
    • The Choose Question is based on the Forms Template design, so if a form is inserted with a script and the script does not define the alias, only the type, the value will not display correctly in the Patient form.
    • When changing an EDC Connection for an existing Visit Data field, if you are changing the path to a different form, it is best practice to delete that Visit Data and create a new one. If you do not do this the data on the Patient Form could display incorrect.


Additional Date Fields

The Date Data Type is utilized only for dates required to build the Patient Visit Schedule Report. When Date is selected from the Data Type field the following fields will appear:

Note: These fields do not appear at initial entry for the first Date, but will if the user clicks the Edit option. They will appear automatically for the second Date field added.


  • Unscheduled Visit Field: The Unscheduled Visit field is a dropdown field used to identify whether a visit is unscheduled visit. The options are Yes and No, with No set as the default.
  • Dependent Baseline Field (Date Data Types only): The Dependent Baseline field is a dropdown field used to identify which visit is the dependent baseline for this date. If the visit date being added is dependent on an existing visit date, the dependent visit should be selected. The options are all existing date fields.
  • Projected Date Window Field (Date Data Types only): The Projected Date Window field is an integer field used to identify the number of units from the baseline visit the visit shall occur.
  • Baseline Window Unit Field(Date Data Types only): The Baseline Window Unit field is a dropdown field used to identify the units used for the integers entered in the Projected Date Window, -Window and + Window fields. By default options are:
    • Days
    • Weeks
    • Months
    • Years
  • - Window Field (Date Data Types only): The – Window field is an integer field used to identify the low end of the date range from the Projected Date Window the visit can occur.
  • + Window Field (Date Data Types only): The + Window field is an integer field used to identify the high end of the date range from the Projected Date Window the visit can occur.

Visit Schedule Table

The Visit Schedule table will display all visit data added. The Question column will display the name of the question and the Patient Status column will display the patient status defined for each visit data.


Edit Icons: The Edit Visit Data screen will appear with the visit data information for the question record.

Delete Icon: A confirmation screen will appear. Selecting Delete will delete the Visit Data record; selecting Cancel will stop the delete action.

Move Question Order: On configurable forms you can control the order in which the questions appear. With the proper permissions, users can click and drag a question up or down to change the location of the question on the screen.


Activate Visit Data

Once visit data has been added to the Visit Schedule form and the configuration is finalized, the visit data needs to be activated. This is necessary to make the visit data accessible on the Project Planning form, Site Enrollment and Patient data.

If visit data is updated after the initial activate the visit data needs to be activated again to make the changes accessible on the Project Planning form, Site Enrollment and Patient data.

Access Activate Visit Data

The Activate Visit Data can be accessed by clicking the “Activate Visit Data” action found in the Actions Menu on the Visit Schedule form.


A dialog will appear for the user to review the active version and activation date. Select Activate  to continue activating the visit data. Click Cancel to close the dialog and abandon the visit data activation.


A confirmation dialog will appear to confirm the activation of the current configuration of the Visit Schedule for the study. Select Confirm to activate the visit data and Cancel to close the dialog and not active the visit data.

The activation process runs in the background and could possibly take several minutes, dependent upon the size of the project. To view the progress or the time to complete, repeat the action to activate. You will either see a progress bar (refresh to update progress bar) or a table sharing the current version. Click the “View Previous Results” link in the top left to view the start and stop times for the prior activation.


Version History

When the Visit Schedule configuration is activated a new version is stored for the study. Versions can be compared to view the changes made with each activation. The Version History of the Visit Schedule can be accessed by clicking the Version History action found in the Actions Menu on the Visit Schedule form.


The Visit Data Version Manager will appear listing all versions that have been activated. The Visit Data Version Manager will contain columns with the Version Number, the Activated Time Stamp and who activated the version.


When 2 or more versions are listed in the manager, the Choose an Action – Press Go! dropdown will contain a compare option. Select the two versions to compare and select Go.


The Differences Between screen will appear with a row for each different setting between the two selected versions.




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