Upload Informed Consent Template

Overview

Management of ICF templates for a study occurs within the Study > Configure > Informed Consent module. Subject-agnostic ICFs templates which are added here can be used to facilitate subject informed consent data collection within the Study > Subjects module. If paper ICFs are being signed, the unique barcode number associated with each ICF loaded here becomes integral to the informed consent data collection workflow.

Only active/approved ICFs may be documented as signed; and downstream activities (including data collection) may be optionally blocked until successful documentation of a signed active/approved ICF has occurred.

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Add an ICF

Click the Add button to configure a new ICF template for the study:

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When adding a new ICF template, the following actions can be taken:

• Version: Version of the ICF. Must be uniquely named per study.

• Type: Either ‘Primary’ or ‘Genomic’, depending on the type of ICF.

• Inclusion Cohorts: Optionally specify to which cohorts the ICF applies. Only subjects who have been activated within the specified inclusion cohorts are eligible to sign the ICF.

• Exclusion Cohorts: Optionally specify to which cohorts the ICF does not apply. Subjects who have been activated within the specified exclusion cohorts are not eligible to sign the ICF.

• Description: Optionally provide further details about the ICF and its use.

After an ICF template has been added, then the following actions can be taken:

When editing an existing ICF template, the following actions can be taken: