Role: Study Designer
Forms are data collection pages that capture information about a given topic at a specific time point. For instance, a demographics form would capture information about a subject’s age, gender, race, and ethnicity; and is typically scheduled as part of a screening visit. As another example, a PK form would capture the date and time of a blood draw and would be scheduled at multiple time points during the treatment stage of a trial.
Import Forms from Library
The quickest way to assemble forms is to import existing forms from another study or from an established ‘standard form library’. Imported forms can always be edited after importation to accommodate unique study design.
Device Integration Forms
Device integration forms interface with external data collection devices, such as vital signs and ECG machines and scales. These forms pull data from the connected device and save that data in ClinSpark with little-to-no user interaction.
Volunteer Integration Forms
Volunteer integration forms interface with ClinSpark’s volunteer database to save information about demographics, medical history, medications, and substance into a specific study. The goal is to maintain this information against a volunteer’s profile in support of robust database searching; and pull that data into a specific trial database as needed.
Base Forms
Common Forms
Forms can be marked as ‘Common’, indicating that the form cannot be scheduled as part of an activity plan but rather users can add a common form to a ‘Common’ study event in an ad-hoc fashion. This allows for controlled adding of forms on the fly. For example, Adverse Event forms are typically marked as common and are added to an Adverse Event study event when AEs occur. In this way, Adverse Event records are easily and reliably located.
Study-Specific Forms
Study specific forms can be constructed from scratch if an existing template or starting point doesn’t exist in another study library. Building unique forms relies on creating a form containing one-to-many item groups, with each item group containing one-to-many items.
Add New Form
A form typically contains data fields related to a given topic and intended to be collected at a certain point (or multiple points) in time. As an example, a dosing form captures information related to study product administration (such as time of administration, formulation, amount of product administered, etc) and is scheduled at each anticipated timepoint for dosing. ICF requirements, subject wristband scan requirements, and default timing deviation windows are established at the form level.
Add New Item Group
A form must contain at least one item group. Item groups allow for sub-topic organization within a form. Domains/datasets are established at the item group level, allowing for a single form to export data into multiple datasets. For example, a demographics form may contain one item group with data fields related to basic demography which report into a DM dataset; and may also contain another item group with data fields related to reproductive status/history which report into a RP dataset.
Add New Item
Think of items as data fields. Each item group must contain at least one item. Items can vary in data input type and may be marked as reportable data (CRF) or strictly source data (Protocol). Optionally, items can have sample processing paths or safety lab panels associated; and for numeric input types, upper and lower allowable ranges may be established. For example, a BMI item would accept a numeric input type and may have an upper and lower acceptable limit.