Page Comparison

An unsigned version (‘template’) of one-to-many informed consent documents for a trial may be loaded in PDF format on a per-study basis. Upon loading an ICF ‘template’, ClinSpark will barcode the template to ensure that only active and approved ICFs are allowed to be distributed for subject signing and documented as part of subject records.

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.Upon uploading

Image Added

Add an ICF

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

Image Added

When adding a new ICF documenttemplate, the following fields may actions can be completedtaken:

Image Added

• 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:

Image Added

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

Image Added