Add and Configure the Study

Before a study can be interacted with, it must be added in ClinSpark and a number of study-specific configuration actions must be performed.

Add the Study

Adding a new study begins by navigating to Administration > Studies and clicking the ‘Add’ button. This is the first action that occurs for every new study, after which a number of study-specific settings must be configured.

Configure Basics

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The following actions can be performed here:

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When ‘Editing’ study basics, the following actions can be performed:

First, establish the following basic configuration fields:

• Name: ‘Nickname’ to be displayed via the Study Selector.

• Protocol Name: Used for reporting of final deliverable datasets.

• Description: Describes the type of study and related details.

• Maintain Timing Offsets with DST: Defines how timing will be affected when daylight savings time is encountered. If Yes, time points relative to dosing will be maintained. If No, time of day will be maintained instead.

• eSignature Strict: Defines whether one- or two-part authentication is required for data review signoffs during a login session. If checked, Username and Password are required for every signoff during a login session. If unchecked, Username and Password are required for the first signoff during a login session and Password-only is required for subsequent signoffs during that same login session.

• MedDRA Dictionary: Establishes the dictionary to be used for coding of medical conditions for the study.

• WHO Drug Dictionary: Establishes the dictionary to be used for coding of medications for the study.

• Sites: Establishes the site(s) at which the trial will be performed.

• Epoch Names: Establishes the ‘stages’ of the trial, typically delineated by potential stopping points at which a subject may not necessarily progress forward.