Informed Consent Forms

Summary

This demonstration provides an overview of informed consent functionality end-to-end in ClinSpark.

Primary vs. Genomic ICF

ICF workflows are slightly different for Primary and Genomic types.

Genomic ICFs are implemented as such, closely aligned to workflows and intended use for documenting subject consent to perform genomic testing. These are not considered the same as ‘supplementary’ or ‘secondary’ consent documentation, which may be considered optional to primary consent types.

Primary ICFs are collected via Study > Subjects. They are presented once the base form with the ‘Informed Consent’ base type is available for the study, and, ICFs are loaded via Study > Configure.

Genomic ICFs however must be scheduled as part of an activity plan in order to be collected against. However, scheduling as part of an activity plan does indeed force a Genomic ICF to present in the Study > Subjects module as well. This may lead to confusion about where to document each ICF signing, so it’s important to test this workflow ahead of any activities where each ICF type is expected to be used.

In a future release, ClinSpark will further explore capabilities to support ‘supplementary’ or ‘secondary’ (meaning the non-primary) ICF workflows. Customers are encouraged to reach out to Foundry Health via service desk ticket if there are questions on this topic.

Study Metadata & Informed Consent Forms

An Informed Consent Base Form is one of the required study base forms, and must be appropriately configured as part of study metadata in order to change a study into active status.  Additionally, the presence of the base form enables the use of specialized workflows within the Subject component. The data collected against ICF forms is also surfaced and referenced in the Subject component to give study teams an oversight on ICF status and progress.

Open

Open

The ICF base form configurations can be reviewed by ClinSpark users with the proper role action to modify study metadata and study library forms.

While the base form must be present in the study library, sites opt-in to using the form and features as needed per study.

ClinSpark comes with a Base Form Library that contains a standard ICF form design, offering sensible defaults for sites to use as a starting point. Sites can further modify their own Subject Informed Consent forms as needed, so long as the Form references Items that are appropriately configured with the required ICF Base Types.

Locking validation will check to ensure that all of these these requirements for use are met. As part of the default form design, these Items each with a ‘ICF’ base type associated that serve a function in the interface.

• ICF - Date

• ICF - Version

• ICF - Notes

Genomic ICF Base Type

As part the base Form definition, sites can decide to also add and use Genomic ICF forms. These have their own base type, which can be applied to Genomic ICF form designs.

Multiple ICF Forms

Sites can use multiple ICF forms in their study design as needed. Most commonly, we see this in studies that require both a standard ICF and Genomic ICF type.

In any use case where multiple ICF forms are needed, the same locking validation applies for use. Whenever a form has an ‘ICF’ base type requirement, it must pass the locking validation and ensure contained Items all appropriately configured with the three required ICF Base Types (Date, Version, Notes).