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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.
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