Summary
This article covers accessing the site visits form, as well as information on planning site visits and adding monitoring reports.
Table of Contents
- Access Site Visits Form
- Site Visits Table
- Choose an Action – Press Go
- Plan Visit
- Conduct Visit or Create Site Visit Report
- Default Fields
- Site Visit Report Transitions
- Populate Site Visit Reports
- Offline Site Visit Reports
The site visit reports for each site for the study are managed through the Site Visits form. It is from this screen that site visits are planned and monitoring reports are added. Prior to planning visits or adding reports, the following steps must take place:
- Clinical Plan > Monitoring Plans > Monitoring Visits > Assign report templates
- Clinical Plan > Monitoring Plans > Visit Plan > Add visit frequencies
- Study Form > Select Study Workflows > Select a site visit approval workflow
Access Site Visits Form
The Site Visits form for each site can be accessed under each site’s Study Menu.
Site Visits Table
The Site Visits table is organized by columns: 
| Name | Value | Action | Sortable | Filters |
| Visit Name | The name of the visit | (none) | Yes | Text |
| Visit Type | The type of visit completed | (none) | Yes | Choice |
| Projected Date | The projected visit date(s) when the visit is dependent on a baseline visit or study activity. If dependent values are missing, will say “Unspecified”. | (none) | Yes | Date |
| Scheduled Date | The scheduled visit date (visit not necessarily dependent upon a baseline visit or study activity) | (none) | Yes | Date |
| Visit Date | The date(s) of the site visit | (none) | Yes | Date |
| Reporters | User who created report | (none) | No | Text |
| Transition Step | The approval transition step in which the report is currently | (none) | Yes | Choice |
| Submitted | The date the report was transitioned into the status defined in the approval workflow as the date of submission | (none) | Yes | Date |
| Finalized | The date the report was transitioned into the status defined in the approval workflow as the date of finalization | (none) | Yes | Date |
| Editor Options | Read, Edit, Delete | Actions as listed for those with appropriate permissions | No | No |
| Audits | Review report transition steps and comments | Displays audit record | No | No |
Note: The Edit and Delete icon will become inactive when the monitoring report has been transitioned to a status that locks the report.
Choose an Action – Press Go
The Choose an Action – Press Go dropdown can be expanded by clicking and contains the following options:
Export by Template
Choosing this option will generate a folder containing an Excel export with the selected monitoring reports sorted into separate tabs by each monitoring report template type. This will allow you to compare responses to questions across visit reports of the same type.
Export to Excel
Choosing this option will generate a folder containing an Excel export of each selected monitoring report.
Export to PDF
Choosing this option will generate a folder containing PDF exports of each selected monitoring report. This option captures eSignature details applied in Monitoring Report Workflow transitions made to the trip report after it was created.
Plan Visit
CTMS has the ability to program a visit plan for studies to ease in the planning of site visits. With this ability, each site’s visits can be scheduled based on that programmed predictability.
Note: If a milestone that is a visit's dependent baseline is marked complete, that will trigger the planning and the planning messages on the Site Visit form. Changing or removing the completion date of the baseline milestone will not remove the planning or the planning message. Once the planning is triggered, changes to the visit planning must be made manually. The planning will then update with the next activity.
It’s possible that your study team plans a visit without utilizing the predictive tools. If that is the case, you can easily manipulate the timing manually and the system will still capture the needed historical detail.
If you reject the prompts, you can once again select Plan Visit from the Actions menu.
Complete New Site Visit Window
- Visit Type
- Name of Site Visit
- Plan
The system will analyze the data you selected and based on the Visit Plan your study team created, prompt you to the next expected visit. If an exception is made and your visit is not part of the expected plan, you can create a visit independent of the prompts.
Visits without an Expected Timeframe:
First site visits or visits without an expected timeframe will prompt for a projected date range for the visit. Complete the date ranges and the visit will be present on the site’s Site Visit table.
Visits Occurring within the Visit Plan
The plan’s expectations will be present in the window. You can select the specific dependent baseline or project a date independent of the expected baseline for this type of visit.
Selecting the expected baseline will display the plan’s details as they apply to the visit you have chosen. The Specify Window is present in the case an adjustment is necessary. Once saved, the visit will be present on the site’s Site Visit table.
Conduct Visit or Create Site Visit Report
From the Site Visit table, select the Conduct Visit button to generate the report.
When a Site Visit Report is added the Select Visit Type dialog appears. The dropdown will contain an option for each Monitoring Type defined on the Monitoring Type Managed List. A black alert will fire if the monitoring type selected does not have a template assigned to the type on the Monitoring Visits form for the study.
After choosing a visit type that contains a template assignment, click Next and a new monitoring report will appear based on the template assigned.
Default Fields
The Site Visit Report form contains the following fields by default. The other fields found on the monitoring form are based on the template configuration as defined in the Site Visit Template Manager.
Start Date Field
The Start Date field is a date field used to identify the date the site visit started. By default, the Start Date field is a required field and a black alert will fire if the Start Date is not provided. The form cannot be saved until the start date is provided.
Stop Date Field
The Stop Date field is a date field used to identify the date the site visit ended.
Name of Monitoring Visit Field
The Name of Monitoring Visit field is a dropdown field with all Monitoring Visit Names from the Monitoring Visit Plan.
Site Visit Report Transitions
Site Visit reports are transitioned through the workflow defined for the study. For the monitoring reports to go through the defined workflow the monitoring report must be transitioned to each step. When a user has the permissions to transition a site visit report the Transition Step will include the transition icon. The Edit Study form contains the workflow window where the study team will assign the all study workflows. The workflow selected there determines the transition paths available for site visit approval transitions.
To Transition a Site Visit Report
- Select the transition icon (
) beside the current transition status of the site visit report.
- The Transition Dialog shall appear.
- Select the Transition To dropdown to select the next workflow step.
- If the Transition step requires an eSignature the Transition Dialog will display the Username and Password Field.
- The Comments field can be utilized to provide or respond to feedback
- Click Confirm.
Populate Site Visit Reports
Users are able to populate monitoring reports with activity from the EDC (if connected to Fountayn’s EDC) or study data within CTMS. To do this, click the “Populate Fields” action found in the Actions Menu on the Site VisitReport form. The populate fields action is used to populate the Connection Fields defined on the Site Visit Report.
Once the Populate Fields action is selected the Select Data dialog will appear.
- User – Select the user who performed the data cleaning actions in Fountayn’s EDC that needs to be reported on the monitoring report. The User dropdown will populate with options of users defined on the Study Personnel form, Site Personnel and Vendor Personnel for the study. The user’s account must be linked to a Fountayn account to appear in the dropdown.
- User is a required field, the Populate Data will not execute until a user is selected. If only populating the monitoring report with CTMS data and not EDC data any user can be selected from the dropdown.
- Date Range Start – Select the start date of when the data from EDC shall be populated. If populating data from CTMS only, the Date Range indicates the data as of that date.
- Date Range Stop – Select the end date of when the data from EDC shall be populated.
For example: User Sherry Smith monitored at site 101 from 05-MAY-2016 to 06-MAY-2016. The User select will be Sherry Smith, the Date Range would be 05-MAY-2016 to 06-MAY-2016.ul>
Upon selecting populate the template connection fields will populate with the associated data.
Offline Site Visit Reports
There may be instances when it is more convenient or is necessary to complete a Site Visit report while offline, and then load it to a visit record later. This functionality is available to users with the role/permission to write access to site visit reports.
Download Monitoring Report Template
Generate the report (conduct) then from the Actions button download the template.
Select the appropriate visit to prompt the desired template. Click Next.
You will then be brought to the Site Visit Monitoring Report screen. Click the Actions button and select Export Template.
Save the template with an appropriate name and complete the visit information, with answers matching the form configuration. You can either click Cancel on this site visit record or complete the Start and Stop Dates for the visit you will be reporting on and save the form.
Complete Monitoring Report Offline
Once a template has been saved, it can be completed offline. Answers entered into the Excel monitoring report template must match the answer format expected by the fields configured for the template. For example, the answer entered in the cell for a dropdown question must be a valid dropdown option. If an error is received when trying to upload the form, confirm that the answers entered follow the form configuration as well as answer format (ex. date formats).
Upload a Completed Monitoring Report
A monitoring report that has been completed and saved offline must be uploaded to a saved visit record. If a site visit record has already been created for this visit, then select the visit’s edit icon. If a new site visit is required, select Add Monitoring Report from the Actions menu and select a visit type (click Next). From the Actions button, select Load Report.
If all answers match the formatting and configuration expected by the report, then the fields will populate from the Excel template. If any answers or fields do not match the formatting and configuration of the online form, then an error will appear stating that the template does not match the active configuration. If this error occurs, simply review for the discrepancy, correct the affected fields in the Excel document save and attempt to upload again.
Need more help?
Please visit the Fountayn Contact Information page.