Introduction

ClinSpark is a best in class, standards based, CDISC ODM certified eSource system and is offered exclusively via Software as a Service (SaaS) hosted on AWS and uses their MySQL compatible Relational Database System (RDS) - Aurora. It empowers nearly all clinical data management activities for early phase clinical research sites. ClinSpark leverages device and systems connectivity while employing a mobile-first design approach. ClinSpark is intended for all persons involved with the success of a clinical trial including bedside data collectors, study monitors, clinical research coordinators, and lab technicians.

Accessing ClinSpark

ClinSpark is designed and tested for use against the latest stable version of Google Chrome. However, we have seen ClinSpark successfully used on other Chromium based web browsers such as the latest version of Microsoft Edge.

Whilst ClinSpark is developed and tested using Google Chrome, we expect and experience excellent compatibility and performance will all chromium-based browsers, including Microsoft Edge.

More details about accessing ClinSpark in various contexts can be reviewed in this article: Computing Devices

Browser Extensions

Modern web browsers offer a capability for users to install programs called ‘Extensions’. These can be manually installed by users, or automatically by IT/IS organizations at customer sites in order to change the browsers default functionality. Most of the time, these extensions are useful and modify the browser as a convenience for the user. Here are some examples:

• Password managers (such as 1Password)

• Screen recording tools (such as Loom)

• Endpoint protection (such as Forcepoint)

Most browser extensions do not interfere with ClinSpark. However, we have seen certain wide-spectrum content filters (such as AdBlock, uBlock, etc) interfere with certain features.

Some extensions may be able to be safely disabled when using ClinSpark, or, rely on configurations to ‘whitelist' the ClinSpark application from being impacted by their features. Customers that have questions about this topic are encouraged to reach out to our support team for further information.

Mobile Devices

Mobile web browsers are optimized to display content most effectively on smaller screens and portable devices. Mobile interfaces also vary across device, for example, making use of gestures and touch-screen controls. While mobile browsers are becoming increasingly more sophisticated, they still do not fully match the user experience as their desktop counterparts.

ClinSpark is developed to be mobile friendly, using the latest web technologies and principles such as responsive design. The mobile ClinSpark experience may vary depending on the intended use of the application.

Session Management

Modern web applications such as ClinSpark rely on session management capabilities to manage the exchange of requests and responses between users and apps. Whenever a user visits ClinSpark via web browser (such as Google Chrome), a session is established which contributes to the overall user experience. Additionally, modern browsers allow support the use of multiple tabs or windows. What this means is if a user choses to access ClinSpark across more than one active browser session in multiple tabs/windows, the user experience may vary depending on the actions that are taken between each active session.

ClinSpark was designed with the intent of users accessing the application and performing actions in a single browser sessions (tab or window). Although, accessing ClinSpark through multiple concurrent sessions across tabs/windows can be beneficial in limited scenarios. However for most use cases, it is not necessary.

Due to this, there may be an undesirable user experience in ClinSpark if performing actions across multiple active sessions. For example, if in one window a user is accessing a subject record in Study ABC, but in another window decide to switch to Study XYZ and complete another action. When returning to the first window accessing Study ABC, actions taken will no longer be contextual to that study, since the last action taken by that user in the application was in Study XYZ.

If deciding to access ClinSpark across multiple active sessions, it’s strongly recommended to do so against the same study selection. For example, in one window accessing the details of Subject S0001 in Study ABC, and in another window accessing details of Subject S0002 also in Study ABC.

Depending on the use case, using session management can be beneficial to certain workflows. However for most users, it may not be necessary.

Environments

ClinSpark is provided to customers in an environment that contains an instance pair often referred to as “Production” (PROD) and “Test” (TEST). PROD and TEST instances are referred this way from the perspective of study design, not from the perspective of systems lifecycle.

The PROD instance contains all live production volunteer and study data. This is a customer’s main ClinSpark environment.

The TEST instance is usually running in a configuration called ‘Test Mode’, which by design prevents certain settings from being modified. The TEST instance may also contain slightly different system configurations from PROD as well. If the ‘Test Mode’ setting is enabled, then the instance will allow a study design to be imported into existing studies via Administration > Utilities component.

For example, when a Study Designer is building a study, they may want to test forms or overall study design prior to actual use. To support this, the Study Designer can build forms in PROD and export their design to TEST in order to execute a simulated execution of the study design. This export capability, as visually depicted below, also allows clinical staff to execute the study for training purposes in order to get a feel for all of the involved study activities.

URLs

A typical ClinSpark URL convention is as follows:

• Production instance: https://org.clinspark.com

• Test instance: https://orgtest.clinspark.com

Note: “org” in org.clinspark.com would typically be represented by your organization’s name or initials.

Other URL conventions may be followed for lower environments, such as Validation or Sandbox environments, which are used during onboarding and upgrade periods.

Other environments

Foundry Health may provide customers with temporary environments to support onboarding, user acceptance testing, and/or validation testing. These temporary environments would typically follow the same previously described structure of “production” and “test” instances for CRF design and study activity testing.

See also

• Onboarding Environments