Summary

ClinSpark was designed and is implemented around a common set of terminology and industry concepts, closely aligned with the definition of CDISC terms. However, certain terms used in ClinSpark may be new to our customers that come from a variety of backgrounds. This article will outline the standards based terms and more specific ‘translations’ of certain concepts used in ClinSpark.

CDISC Glossary

CDISC maintains a glossary with purpose of clarifying and disambiguating key concepts in clinical research. It’s available online in various formats, with full details covered on the CDISC website.

As a helpful reference, we recommend ClinSpark users utilize the hosted HTML version of the glossary online. This is a useful resource while learning about ClinSpark and concepts applied in clinical research.

ClinSpark Terminology

ClinSpark may apply a slightly different representation of common clinical trial concepts, as it would relate to specific workflows or features. ClinSpark may also allow uqsers to apply their own use of those concepts through study design functions. The following is list of some of these terms and their ‘translated’ meanings.

Epochs

When establishing basic study configurations, users have the ability to define one more Epochs. Epochs are a way to help organize studies. The definition and use of Epochs for any given study will depend on the protocol, and, the needs around conducting trial activities.

Protocols can dictate sequential milestones in a trial. Examples of Epochs from traditional ‘early phase’ protocols could be: ‘Screening’, ‘Lead In’, ‘Treatment’, and ‘Follow-up’.

Studies can also be configured to use a more simple Epoch structure, which may be more common in ‘later phase’ style protocols.

Cohorts

Within a given Epoch, users have the ability to establish Cohorts. Cohorts are a way to help organize Epochs. Cohorts are groups of Subjects that will go through study Epochs together, usually having some common denominator (dose regimen, gender, age, etc.)

For larger trials, or those with several arms, multiple cohorts are established to help stay organized. Each cohort, or group, contains one or more cohort assignments.

Cohort Assignments

A Cohort Assignment is created within a study Cohort. It is a placeholder for a study Subject record that would be used to determine a subject number, activity plan, and volunteer reference throughout one or more study cohorts.

Through activations, a Cohort Assignment creates a link between a Volunteer and an Activity Plan to enable the Data Collection activities on a subject record.

Subjects & Volunteers

A volunteer is an individual who has expressed interest to participate in one or more clinical trials.

A subject is a clinical trial participant that has typically been recruited into a study and selected on the basis of the protocol’s inclusion and exclusion criteria.

In ClinSpark, subject is a study specific term applied to an identified volunteer via the actions taken through a cohort assignment.

Outside of ClinSpark, the term volunteer may sometimes be used interchangeably as a synonym for study subject. However, volunteers and subjects are different terms and concepts in ClinSpark.

Through the interactions of a study specific cohort assignment, ClinSpark will ‘join’ a volunteer and an activity plan, to establish the subject record. Once joined through cohort assignment activations, the subject record is associated with a volunteer for that study.

Subject & Volunteer Profiles

Within the context of a given study, a subject profile is created for each Subject activated through a Cohort Assignment. This study specific subject profile can be viewed in the Study > Subjects module, which gives an overview about the subject and supports a variety of PI workflows.

For a given subject, there will be an underlying volunteer record, represented with an immutable ClinSpark ID number. This volunteer record represents the profile of the individual person that may be recruited into different studies, and become associated with many subject records. The full volunteer profile can be viewed within the Volunteers > Manage module, providing an overview of that individual’s demographics, health, correspondence, and study involvement over time.

Study Library

A Study Library defines a collection of study specific metadata and forms that will contribute towards Activity Plan designs and supporting various data collection workflows throughout a study.

Forms

Forms are designed to support data collection workflows - for example: ECG Form, Vital Signs Form, Medical History Form, etc.

Forms can be created specifically for a study or imported from an existing library of forms previously created and used.

Certain forms influence workflows for Device Integration and Volunteer Integrations. Forms of a specific Base Type are used to facilitate specialized workflows.

Forms and their subsequent entities such as Item Groups, Items, and Code Lists are established in ClinSpark to align with CDISC ODM standards.

Study Events & Visits

A Study Event is known or planned protocol activity, as well as occurrences & conditions independent of planned study activity that may occur during the trial (e.g., adverse events).

Within ClinSpark, these are established as study configurations and then applied to Activity Plan designs by aligning study events to forms. Study events are also applied to certain data collection workflows, such as the creation and use of ‘unscheduled’ forms. An Event Schedule is also considered as an Activity Plan in ClinSpark.

Optionally, Study Events can be configured with Category or Visit # attributes, typically used to indicate the study phase appropriate to the type of study event or as metadata in certain reporting logic.

Open

Open

A Visit is a clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments. A visit typically is a known period of time that has a start and an end. In ClinSpark, the concept of a Visit is applied based upon the protocol and the needs around conducting trial activities.

Therefore, some studies establish Visits as Study Events. On an Activity Plan, the activities the take place at each visit are aligned through the assignment of certain forms to those study events.

Activity Plans

An Activity Plan is comprised of study forms that need to be collected on for a Subject. They are often designed around the intended use for the study Epoch & Cohort structure. For example, the Screening Epoch will have a Screening Activity Plan, the Treatment Epoch will have a Treatment Activity Plan, etc. Activity Plans are associated to Subjects with the help of Cohort Assignments. Activity Plans can have one or more Study Events associated with it.