Role: Clinical Research Coordinator
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. 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 a new ICF document, the following fields may be completed:
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.