Summary

Each Item in an Item Group needs to have a “Data Type” specified. This will define how this Item will appear to users during data collection.

Text

Text can be used with or without a Code List. With a Code List, it can have a list of answers presented to the user. Without a Code List, it will present as a simple text box, where users can type in their text. Allows entry of various characters, numbers, symbols, etc. Requires to have a maximum allowed length defined.

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Integer

Integer Data Type allows users to enter whole numbers (1, 2, 3, …). This Data Type must have a maximum allowed length defined.

For example, user must enter how many pills the Subject took and the maximum number of pills is 5, define the Item as Integer type and define maximum length as 1 (prevents the user to enter 15 by mistake).

Another example, user must enter the age of the Subject and the probable age entry will consist of 2 digits (unlikely to have Subjects younger than 10 and older than 99), the maximum length can be defined at 2.

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Float

Float allows users to enter decimal numbers (1.1, 1.76, etc.). This Data Type must have a maximum length and Significant Digits field defined.

For example, user needs to record the version of the ICF and the version is likely to be 1.0, 1.1, 2.0, etc. Maximum length can be defined as “1” (number of digits before the decimal place), Significant Digits can be defined as “1” as well (number of digits after the decimal place).

Another example, user needs to record the height of the Subject, and it is likely to be something like 1.76 m. or 2.03 m. , Maximum length 1, Significant Digits 2. etc.

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Date 

Date allows users to enter a date using day, month and year dropdowns or click get the system to record current date and time by clicking the “Current time” option. For example, Date of ICF.

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Time

Time allows users to enter a time using hours, minutes and seconds dropdowns or get the system to record current time by clicking the “Current time” option. e

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Datetime

Datetime allows users to enter a date and a time using the dropdowns or click the “Current time” option to get the system to record current date and time.

Good examples are the date and time the Dose was administered or when Blood Sample was drawn.

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String

String is practically identical to “Text” type. Can be used with or without a Code List. With a Code List, it can have a list of answers presented to the user. Without a Code List, it will present as a simple text box, where users can type in their text.

This field will allow entry of various characters, numbers, symbols, etc. It must have have a maximum allowed length defined, when used without a Code List.

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Boolean

Boolean allows the user to select a checkbox, if the answer applies.

This allows to create some “checklist” or “to-do” Items for the Activity Plan, for example, where the only possible answer is “Yes, it was done”, for example, “Luggage Check Complete upon Arrival” could be an example of a use case for Boolean Item Type.

A list of Boolean Items is also a great mechanism for recording multiple responses to a given topic/question.  When setting up a 'multiple response' scenario like this, it's best practice to create a dedicated item group to hold these responses.  The name of the item group could be the question (i.e. "Please indicate all forms of contraception being used").  And then you could create a boolean item per response (i.e. a boolean item for "Barrier method"; another boolean item for "Surgically sterile"; etc).

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File Upload 

File Uploadprovides the user with a “Select file” button that allows to browse files on the computer and upload them into the form.

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Partial Date/Time/Datetime and Incomplete Date/Time/Datetime

Partial Date/Time/Datetime and Incomplete Date/Time/Datetime – both partial and incomplete date fields allow an incomplete date/time/datetime to be entered. The user will not see a difference in these during data collection. ClinSpark supports Partial and Incomplete date fields because CDISC defines each of these. 

Currently though, only partial data types report according to ISO 8601 datetime formatting.  Incomplete do not.

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Duration Datetime / Interval Datetime

Duration datetime/Interval datetime allows manual entry of duration of something or interval. These are rarely (read 'never') used.  In fact, CDISC guidance also admits that the use cases for interval datetimes are rare. The intended reporting format for these variables is to concatenate a start and end time into the same data field (i.e. 2003-12-15T10:00/2003-12-15T10:30).  But practically, both data collectors and data managers would benefit from these datetimes being collected as separate data fields. 

If we imagine an infusion dosing scenario, the start of infusion should be scheduled at a 0hr timepoint and the end should be scheduled X amount of time later.  Scheduling these collections separately allows you to display timing information to your data collectors for each activity and will also include appropriate timepoints in data management exports (i.e. if an infusion begins at a 0hr timepoint, it likely should not also end at a 0hr timepoint). 

Furthermore, the interval and duration datatypes implemented in ClinSpark will currently accept any string of characters and will not enforce that the input is in a date format.

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