Summary

This article covers accessing the patients summary, the patient summary table and importing patients.

Table of Contents

• Access Patients Summary
• Patient Summary Table
  • Add Patient Form
  • Patient Forms for Linked Studies
  • Fields Connected to Dynamic Forms (Ex. Concomitant Meds, AE, Medical History, etc.)
  • Patient Report
• Importing Patients

Patient visit information can be brought into the CTMS study through this form. The fields on this form are defined on the Visit Schedule, found in the Clinical Plan. These fields can be populated 4 different ways:

1. Connected to Fountayn’s EDC with real-time population
2. Utilizing APIs to connect to a non-Fountayn EDC (import schedule arranged between study team and EDC provider)
3. Manually adding patient information using the Action menu options (non-Fountayn studies only)
4. Utilizing the Import Manager (non-Fountayn studies only)

Patients can be accessed or added (non Fountayn studies) from this screen. When a study has been linked to a Fountayn EDC study, patient records are automatically created for each patient at the site. Patient records can be manually created for studies not linked to an EDC study. Patients cannot be manually created for EDC-linked studies.

Access Patients Summary

Patient information is organized by study, then site. The Patients Summary screen can be accessed by selecting the study, the appropriate country, the site name, then Patients.

Patient Summary Table

The Patient Summary table will display one row for each patient.

The Patient column will display the Primary and Secondary Identifiers that were identified on the Visit Schedule for the study.

The Options column will display an edit icon. When the edit icon is selected the Patient Form will appear.

A delete icon will display if the patient form was manually added, when the delete icon is selected a confirmation dialog will display. Select the delete icon to delete the record or cancel to close the confirmation dialog and not delete the record.

Add Patient Form

A new patient record can be created by clicking the “Add Patient” action found in the Actions Menu on the Patient Summary form. This action will only appear for studies that are not linked to an EDC study.

When Add Patient is selected a new Add Patient form will appear. The Add Patient form will display questions as configured and activated on the Visit Schedule form. The Primary Identifier must be entered to save a new patient form.

Patient Forms for Linked Studies

The Patient form for sites that have been linked to EDC studies will auto-populate fields connected to EDC fields in the Visit Schedule for the study. Fields not linked will be open for entry.
The data populated from the EDC will display real-time data as entered in patient casebooks on the EDC. Updated data will reflect in CTMS in real-time.

Fields Connected to Dynamic Forms (Ex. Concomitant Meds, AE, Medical History, etc.)

A question on the Patient form may be connected to an EDC dynamic form (forms that could have 0-unlimited instances, such as Medical History, Concomitant Medications, Adverse Events, etc). The Patient form will display the recurring question based on the highest occurrence of that form in the entire linked study. For example: If the highest number of AE forms completed for any patient in the study was 10, then all Patient forms will have 10 fields for the AE question, even if not fully utilized.

Patient Report

The Patient Template is study-specific and based on the study Visit Schedule, which determines the patient data collection. When the template download icon for Patients is selected the Select Study dialog will appear. Studies that are linked to Fountayn EDC studies will not appear in the Select Study dialog, only unlinked studies can be imported. Once a study is selected and the download button is clicked, the template will download.

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Primary Identifiers & Required Fields

For all Import guidelines click here.

Importing Patients

The Patient Template is study-specific and based on the study Visit Schedule, which determines the patient data collection. When the template download icon for Patients is selected the Select Study dialog will appear. Studies that are linked to Fountayn EDC studies will not appear in the Select Study dialog, only studies not linked can be imported. Once a study is selected and the download button is clicked, the template will download. 

Need more help?

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