Configuring CTMS Activity Tracking

CTMS Activity Tracking allows you to record Clinical Activities in your CTMS Vault. Before you can begin tracking Clinical Activities in your CTMS Vault, you must configure the Activity (crm_activity__v) object.

Clinical Activity Setup

Before you can begin using CTMS Activity Tracking, you must update several page layouts to include the Clinical Activity object.

Update Page Layouts

Configure the following object page layout updates:

  • Add an Activity related object section to the Investigator, Study, Study Country, Study Site, and Study Person object page layouts.

Automated Clinical Activities (Optional)

Enabling Automated Clinical Activities enhances CTMS Activity Tracking by introducing a job that automatically creates Clinical Activities when Monitoring Event or Study Communication records are created and updated. The automation eliminates the need for study teams to manually create corresponding Clinical Activities after logging Monitoring Events and Study Communications.

To enable:

  1. Add the following fields to the Clinical Activity object type:
    • Monitoring Event
    • Study Communication
  2. Add the following fields to the Study Details section:
    • Monitoring Event
    • Study Communication
  3. For each Monitoring Event object type you wish to automate, add the following Object Type Fields:
    • Activity Update Required
    • Monitoring Visit Method
  4. Edit the Page Layout on the Monitoring Event object as follows:
    • Remove the Activity Update Required field
    • Move the Monitoring Visit Method field to the Monitoring Event Details section
  5. For each Study Communication Log object type you wish to automate, add the Activity Update Required Object Type Field.
  6. Remove the Activity Update Required field from the Study Communication Log page layout.
  7. In Admin > Operations > Job Definitions, edit the Generate Clinical Activities job to activate it.

Configuring the Clinical Operations to Medical CRM Connection

Using the Clinical Operations to Medical CRM connection, organizations with both a Clinical Operations CTMS Vault and Medical CRM can exchange data related to Clinical and Medical activities. To use the Clinical Operations to Medical CRM Connection, you must configure the Activity object, configure the remaining relevant components, and configure and activate the connection.

Medical Activity Setup

To correctly view the Medical Activities from Medical CRM, you must complete the following configuration steps:

  • Update Investigator Page Layout
  • Activate Medical Activity Object Type

Update Investigator Page Layout

Add an Activity related object section to the Investigator object page layout.

Activate Medical Activity Object Type

To activate the Medical Activity Object Type, navigate to Admin > Configuration > Objects > Activity > Object Types and select the Medical Activity Object Type. Edit the Medical Activity object type and change its Status to Active.

Connection

The Clinical Operations to Medical CRM Connection is available in your Clinical Operations CTMS Vault in Admin > Connections. You must establish the connection before you can use it. Once you have configured one connection, you can easily copy it to create a new connection. You can create up to 10 different instances of the Clinical Operations to Medical CRM connection so that your Clinical Operations CTMS Vault can be connected to your different Medical CRM organizations.

Connection Setup: Configuration

Before you begin using the Clinical Operations to Medical CRM connection, you must configure the connection from your Clinical Operations CTMS Vault.

Configure the Enter Connected App Details action

You must configure the Enter Connected App Details action before using the Clinical Operations to Medical CRM connection.

  1. Navigate to Admin > Configuration > Objects > Connection Authorization.
  2. Click the Object Types tab.
  3. Click Actions.
  4. Click the Actions Menu and then select Edit Object Type Actions.
  5. For the Enter Connected App Details action, select the Basic Auth (basic_auth__sys) object type.
  6. Click Save.

Connection Setup: Enablement

You must enable the Clinical Operations to Medical CRM connection in your Clinical Operations CTMS Vault before it is ready to use. This includes:

  • Enable and authorize the connection
  • Activate CRM/Clinical Operations Transfer job
  • Enable Multiple Connections (optional)
  • Update User Exception Page Layout
  • Create User Exception Report
  • Schedule User Exception Report

Before You Begin

Vault uses the Connection Authorization to store login credentials and other information it needs to retrieve data from Medical CRM. Before you begin, you must find or create a connected app and gather the following information from Medical CRM:

  • The Consumer Key and Consumer Secret from Setup > App Setup > Create > Apps > Remote API Access
  • The Medical CRM Username and Password for your dedicated integration user

Enable and Authorize the Clinical Operations to Medical CRM Connection

The Connection Authorization and Authorized Connection User options are recommended when configuring an external connection that retrieves data from Vault.

The Connection Authorization is intended to store the user name and password of the external system and can be passed in the message header for authentication on the external system. There must be processing on the external system to handle the user name and password and authenticate on the external system.

The Authorized Connection User can be used to generate a SessionID that can be passed to the external system and used for subsequent API callbacks to retrieve data from Vault.

  1. Navigate to Admin > Configuration > Connections.
  2. Click the Clinical CRM Connection.
  3. Click Edit.
  4. Update the Name field with the name of the CRM organization to which you are connecting.
  5. Enter a URL for this external connection. This URL must be in a valid HTTPS format including https://. Only the standard HTTPS port is allowed, for example, https://veeva.com:8443 is not allowed.
  6. Optional: Select an Authorization record for this external connection. If the external connection needs to access data in this Vault, they will do so through this Connection Authorization record. If none exist, you can create one.
  7. Optional: Enter a Description for this connection.
  8. Click Save. The connection record is created in an Active state and is available for use immediately.

Next, authorize the connection.

  1. Click the Authorization field and select Create Connection Authorization.
  2. Enter the name of the Medical CRM user you are authorizing in the Name field.
  3. Enter the username of the Medical CRM user you are authorizing in the Username field.
  4. Click Save.
  5. From the Actions Menu, select Set Password.
  6. Enter the Medical CRM password for the user you are authorizing the Password field. Confirm the password in the Confirm Password field.
  7. Click Save.
  8. From the Actions Menu, select Enter Connected App Details.
  9. In the Connected App Consumer Key field, enter the key from Medical CRM.
  10. In the Connected App Consumer Secret field, enter the secret from Medical CRM.
  11. Click Save.

You can get the Consumer Key and Consumer Secret from Medical CRM in Setup > App Setup > Create > Apps > Remote API Access.

Clinical Operations to Medical CRM Connection Settings

Update the Clinical Operations to Medical CRM Connection settings.

  1. Navigate to Admin > Settings > Application Settings.
  2. Click Edit.
  3. Select the Enable Global CRM Connection Identifier Mapping checkbox.
  4. Enter the unique identifiers for both your CTMS Vault and Medical CRM in the appropriate fields. For example, in the Clinical Person Identifier field, enter the field API name from the Person object. In the CRM Account Identifier field, enter the field API name from the Account object.

For the Clinical Operations to Medical CRM connection to work properly, you must establish a link between the Clinical Person and the CRM Account Identifier. The Clinical Person and CRM Account Identifier fields are case sensitive. They must also be unique.

If you are setting up multiple Clinical Operations to Medical CRM connections, you can specify the CRM Account Identifier using the corresponding CRM Connection Identifier Mapping record to map to different identifiers in different Medical CRM instances.

When running the connection, Vault first checks for a mapping on the CRM Connection Identifier Mapping record. If one isn’t specified here, it will use the global CRM Account Identifier from Settings. If this is also not specified, the connection fails with a user exception error.

Activate the Clinical Operations to Medical CRM Transfer job

The CRM/Clinical Operations Transfer job runs the Clinical Operations to Medical CRM connection. This job runs once per hour once you have activated it.

  1. Navigate to Admin > Configuration > Operations > Job Definitions.
  2. Click the CRM/Clinical Operations Transfer job.
  3. Click Edit.
  4. Change the Status to Active.
  5. Click Save.

Enable Multiple Connections

If desired, you can establish up to 10 separate Clinical Operations to Medical CRM connections to use with different CRM organizations. Once you have successfully configured the first Clinical Operations to Medical CRM connection, you can easily connect another by copying the existing connection.

  1. Navigate to Admin > Configuration > Connections.
  2. Click the Actions Menu of your existing connection.
  3. Select Copy to New.
  4. Update the following connection fields with the appropriate information:
    • Name: the name of the CRM organization to which you are connecting
    • URL: the URL of the CRM organization, including https:// and .com
    • Description (optional): a description with details about the CRM organization to which you are connection
    • Authorization: update the authorization following the instructions here
  5. Click Save.

Standard Field Rules

The Clinical Operations to Medical CRM Connection contains standard Field Rules for Inbound and Outbound Integration Rules. If you make a copy of the Clinical Operations to Medical CRM Connection using the Make a Copy action, Vault also copies the Field Rules. You can prevent the transfer of a non-required field by inactivating the Field Rule.

Restrict Data from Transfer

To prevent the transfer of a specific field, you can inactivate that Field Rule. For example, if you want to prevent the transfer of the From field on the Inbound Integration Rule (Medical CRM to Clinical Operations), you can inactivate the From Field Rule. If you inactivate a Field Rule for a field that is required, however, it results in an error and the transfer fails.

In order to prevent fields from transferring to the opposing system, complete the following steps:

From Transfer from Medical CRM to Vault Clinical:

  1. Navigate to Connections > Integration Rules and select the Field Rule you wish to inactivate.
  2. Inactivate the Field Rule.

From Transfer from Vault CTMS to Medical CRM:

  1. Navigate to Connections > Integration Rules and select the Field Rule you wish to inactivate.
  2. Inactivate the Field Rule.

Update the User Exception Page Layout

Make the following changes to the User Exception object Page Layout:

  1. Navigate to Admin > Configuration > Objects > User Exception Message.
  2. Update the User Exception page layout to include a related object section for User Exception Item. Select the radio button for Prevent record creation.
  3. Ensure that the columns in the User Exception Items section are in the following order:
    • Exception Item Name
    • Error Type
    • Error Message
    • Item
    • Item Data

Create User Exception Report

We suggest creating a flash report to track and resolve any issues that occur with the connection. First, create a new Report Type:

  1. Navigate to Admin > Configuration > Report Types and click Create.
  2. Populate required fields.
  3. Select User Exception Messages as the Primary Reporting Object.
  4. Click Add Related Object, select User Exception Items (Child) as the Related Object.
  5. Click Save.

Next, create the report:

  1. Navigate to the Reports tab and click Create.
  2. Select the User Exception Message with User Exception Item Report Type and click Continue.
  3. Add the following User Exception Message filters:
    • Status equals Active
    • Created Date is in the last 1 day
    • In the CTMS Vault: Integration in CRM Call Inbound Integration and CRM Call Outbound Integration
  4. Click Edit Columns and add the Error Type, Error Message, Item, and Item Date columns.
  5. Save the report.
  6. Schedule the report to run daily and select the Only send when at least one record is returned option from the Email and Vault notification preferences drop-down.
  7. Update the Sharing Settings for the report to ensure it is sent to the necessary users. We recommend sharing with one or more users on your IT team.

To perform the tasks described in this article, you must have a security profile that includes the following permissions:

Permission Type Permission Effect
Security Profile Admin: Application: Manage Connections Ability to access the Connections tab in Admin and activate the Connections
Security Profile Object: User Exception Item, User Exception Message: Read Ability to see User Exception Item and User Exception Message records if a connection failure occurs