Volunteer Interface Parameters

Summary

Volunteer interface parameter settings establish the connectivity requirements between volunteer data and applicable study forms. Some of the settings also influence collection workflows for health data on volunteer records.

Open

Most of the parameter settings are passed through as sensible default configurations for study Items and Forms. Validation logic on forms will check to ensure there are consistencies between the system configurations and study configurations. If there is an inconsistency, the system will prevent use of the form.

Open

Many of the connectivity parameters are also established with “the end in mind” in order to ensure the data can be reported / aligned with CDASH guidelines and SAS formatting rules. This applies also to volunteer health data definitions. As needed over time, code changes and new releases of ClinSpark will continue to align the default configurations with updated guidelines and newer formats.

Modifying interface parameters

Connectivity parameters are a global configuration that apply across all volunteers and studies in an environment. Most parameters can be modified per request, however it must be done by an IQVIA ‘superadmin’ user. We typically work with customers during onboarding phases to ensure that the parameter configurations meet data collection & reporting expectations before their adoption into study designs and volunteer datasets. Although over time, minor changes to the parameter configurations may be needed. Adopting these changes may improve the overall user experience in the volunteer profile and may allow new/updated study forms to utilize the updates, depending on the changes made.

Certain configurations parameters - for example, the code lists for dose units - will impact what selections are visible in the volunteer area. Those configurations also pass through to volunteer record data entry user experience, and subsequently, the code lists created on applicable study forms/items references.

There is not however a direct relationship between all parameters and the user experience of data entry in the Volunteers component. This is sometimes a point of confusion for users.

We are continuing to review this limitation and consider enhancements that would improve controls over these configurations. If customers have feedback on this topic they would like to share, they are encouraged to reach out via service desk ticket to discuss.

Applying updates to configurations in PROD

If changes to interface parameters are needed, customers must open up a service desk ticket and engage with IQVIA. These parameters can only be modified with the help of ‘superadmin’ users.

Once a change is applied to the PROD MAIN instance, importing a study design into the TEST instance will import the updated parameters into that environment.

With any changes applied to these parameters, the following must be understood and considered:

1. As a global configuration change, it will impact every volunteer and study form that reference the code list items

2. Already collected data will be unaffected

3. For any new data collection, a new form that includes an updated code list that matches these global configurations will need to be used

4. If a form was created prior to this update, that form should no longer be used for any new/updated data collection

5. Existing forms will no longer pass certain validation logic if the associated item metadata and code list values are no longer in alignment with the system settings. This includes any changes to item data types, code list item decoded values, or, when previously used code list values have been removed. Changes to all study form Items and code lists will need to be considered if needing to update form metadata.