Create monitoring configuration

Monitoring Configuration ID*

Represents an ID automatically generated by the system when creating a new monitoring configuration entity. This is an uneditable value.

Monitoring Config Name*

Enter a descriptive name of the monitoring configuration that helps identify this entity when working with it in the system.

Monitoring Configuration Applicable to (Site Code)*

Select sites to which the created monitoring configuration is to be applied. You can also apply this configuration to all sites at once.

Monitoring Visit Type*

Select monitoring types to which the created monitoring configuration is to be applied. The monitoring visits define the type of monitoring that needs to be conducted at sites, outlining the trial goals. The monitoring type can be one of the following: PSSV (Pre-Study Site Visit), SIV (Site Initiation Visit), IMV (Interim Monitoring Visit), or COV (Close Out Visit).

Need Monitoring Description

Select Yes to enable the Description field for users when linking this monitoring configuration to a monitoring visit, allowing them to document study-specific risks, objectives, or key focus areas.

Otherwise, select No if the configuration proceeds without needing that additional explanation, suitable for straightforward or standard visit plans.

SAVE

Select to create the monitoring configuration entity with the Active status.

You can proceed with updating the configurations by proceeding to the following form stages. Otherwise, upon selecting SAVE, the system adds the monitoring configuration entity with the default configurations and you can always change them later by updating the monitoring configuration entity.

Components Required

Select components that need to be mandatory for every created monitoring visit, including Confirmation Letter, Issues & Action Items, Protocol Deviation, Follow-up Letter, ICF Tracking Log, SDV, and SDR.

The Trip Report component is mandatory in the configuration since it is always required in monitoring visits.

Components*

Represents the name of the component and cannot be edited. The number of such fields depends on the number of components selected previously.

Precondition*

Select the action that must be taken for the corresponding component to become available in monitoring visits:

Actions*

Represents the default non-editable value that is Appear. This means that the component becomes available in monitoring visits only after the previously specified precondition is met.

Monitoring Visit Needs to be Approved

Switch this toggle on if you want the assigned CTMS users to approve monitoring visits before implementing them. The system preserves this configuration every time a new monitoring visit is added.

Monitoring Visit Approved by*

This field is available only if the Monitoring Visit Needs to be Approved toggle is switched on in the previous field. Select either of the following options—Role Category (if you want users with a specific role to approve monitoring visits) or the Assignee (if you want specific users to approve monitoring visits).

Role Category*/Assignee*

This field is available only if the Monitoring Visit Needs to be Approved toggle is switched on. If Role Category has been selected in the previous field, then select a role or roles to authorize them for monitoring visit approval. If Assignee has been selected in the previous field, then select a user or users to authorize them for monitoring visit approval.

Expected Days

This field is available only if the Monitoring Visit Needs to be Approved toggle is switched on. Enter the expected number of days for the assignees to complete the approval task.

Type*

This field is available only if the number of expected days is entered. Select whether the working or calendar days need to be considered when calculating expected days.

Monitoring Visit Approval Due Date

This field is available only if the number of expected days is entered. Select the date condition that the system must follow to calculate the due date for monitoring visit approval, considering the number of expected days.

Monitoring Visit Type

Select the monitoring visit type: PSSV (Pre-Study Site Visit), SIV (Site Initiation Visit), IMV (Interim Monitoring Visit), or COV (Close Out Visit).

Trip Report Template Name

Select the monitor template according to which a trip report for the created visit is to be generated.

Trip Report Needs to be Approved

Switch this toggle on if you want a trip report to be approved according to the specific workflow before finalizing a monitoring visit. If the toggle is switched off, you can specify only the expected days for trip report completion.

The system preserves this configuration every time a new monitoring visit is added.

Expected Days of Trip Report Completion

Enter the expected number of days for the user in charge to complete a trip report for monitoring visits.

Type*

Based on the previously entered number of expected days, select whether the working or calendar days need to be considered when calculating expected days.

Trip Report Completion Due Date

This field is available only if you have previously entered the number of expected days. Select the date condition that the system must follow to calculate the due date for completing a monitoring visit trip report, considering the number of expected days.

Workflow Name

Select Associate Workflow to define a workflow for the trip report approval process. You can also indicate due dates for specific workflow steps if needed.

Figure 9. Associating workflow with trip report approval

The workflow can only be selected if the Trip Report Needs to be Approved toggle has been switched on. Also, ensure to configure the necessary workflow for trip report approval beforehand in CTMS.

Whole Trip Report Finalized Due Date

Set the deadline for finalizing the entire trip report, calculated as a number of days after the selected base date.

This field is only available if the Trip Report Needs to be Approved toggle is switched on.

Query Expected Days

Enter the time (in days) allowed to resolve any queries related to the trip report.

Cancellation Letter Template

Select a predefined email template that is to be used when sending a cancellation letter during monitoring visits.

The visit owner should be the email recipient as the default

Select Yes if you want the creator of monitoring visits to be the recipient of the cancellation letter by default.

Signature Required When Sending Letters*

Send to

Select the category of the email recipients, such as a staff member or a role.

Role Category/Staff Name

Based on your selection in the previous field, select the particular role or users to whom you want to set as the email recipients.

Cc

Select the category of the carbon copy (CC) email recipients, such as a staff member or a role.

Role Category/Staff Name

Based on your selection in the previous field, select the particular role or users to whom you want to set as the CC email recipients.

Is it sent as an email attachment?*

Does the content of the email need to be consistent with the content of this attachment?

This field is available only if Yes is selected in the Is it sent as an email attachment? field.

Repeat Send

Indicate if you want the users to be able to resend the confirmation letter (Yes) or not (No).

Confirmation Letter Template*

Select a predefined email template that is to be used when writing a confirmation letter for any of the created monitoring visits.

Expected Days

Enter the time allowed (in days) to send the letter before the due date.

Type*

Based on the previously entered the number of expected days, select whether the working or calendar days need to be considered when calculating expected days.

Confirmation Letter Due Date

Based on the selected type, set the due date by calculating it relative to a reference date (such as, Planned Start Date).

The visit owner should be the email recipient as the default

Select Yes if you want the creator of monitoring visits to be the recipient of the confirmation letter by default.

Signature Required When Sending Letters*

Send to

Select the category of the email recipients, such as a staff member or a role.

Role Category/Staff Name

Based on your selection in the previous field, select the particular role or users whom you want to set as the email recipients.

Cc

Select the category of the carbon copy (CC) email recipients, such as a staff member or a role.

Role Category/Staff Name

Based on your selection in the previous field, select the particular role or users whom you want to set as the CC email recipients.

Is it sent as an email attachment?*

Does the content of the email need to be consistent with the content of this attachment?

This field is available only if Yes is selected in the Is it sent as an email attachment? field.

Repeat Send

Indicate if you want the users to be able to resend the follow-up letter (Yes) or not (No).

Follow-up Letter Template*

Select a predefined email template that is to be used when writing a follow-up letter for any of the created monitoring visits.

Expected Days

Enter the time (in days) allowed to send the letter before the due date.

Type*

Based on the previously entered number of expected days, select whether the working or calendar days need to be considered when calculating expected days.

Follow-up Letter Due Date

Based on the selected type, set the due date by calculating it relative to a reference date (such as, Planned Start Date).

The visit owner should be the email recipient as the default

Select Yes if you want the creator of monitoring visits to be the recipient of the follow-up letter by default.

Signature Required When Sending Letters*

Send to

Select the category of the email recipients, such as a staff member or a role.

Role Category/Staff Name

Based on your selection in the previous field, select the particular role or users whom you want to set as the email recipients.

Cc

Select the category of the carbon copy (CC) email recipients, such as a staff member or a role.

Role Category/Staff Name

Based on your selection in the previous field, select the particular role or users whom you want to set as the CC email recipients.

Monitoring Visit Naming Elements

Construct a naming convention for future created monitoring visits using the following elements: dash, creation date "ddMMMyyyy," site code, monitoring type, monitoring method, responsible name, ascending number of the monitoring visit, or a custom label.

Monitoring Visit Name is Editable

Select Yes if you want to enable the editing of names of manually created monitoring visits.

If No is selected, the names of monitoring visits created from this monitoring configuration are generated according to the predefined naming convention in the previous field and are read-only.

Auto Finalize Monitoring Visit

Enable or disable the system’s ability to automatically finalize a monitoring visit when all selected criteria are fulfilled.

Criteria*

Select actions that must be completed or the letters that must be sent for auto-finalization to occur.

Appendix(es) Required

Select Yes if the PDF file is required to be exported for the trip report.

Monitoring Visit Type*

Select the specific monitoring type for which the trip report is required to be exported.

Select Appendix Item(s)*

Select the specific appendix items, such as protocol deviation records, action items, issues, or ICF tracking logs that must be required for the selected monitoring type.

Add Content

Select to add another monitoring type to the list of required appendices.

Remove

Select to remove the monitoring type from the list of required appendices.