Hyperlinked PDF (Report)

The hyperlinked PDF report is essentially a hyperlinked case report form that also contains relevant information about programmed data fields and scheduling of data collection for a given trial or stage of a trial.

The hyperlinked PDF is also known as the annotated CRF (aCRF or blankCRF), referred to by FDA in their Study Data Technical Conformance Guide. This document will become part of the electronic submission file together with the SDTM datasets.

The hyperlinked PDF report also contains the normal values used for lab/technical procedures/tests present in the protocol, essential information from an ICH-GCP perspective (Essential Documents - section 8.2.12 and 8.3.7).

The hyperlinked PDF report also answers the definition of the Sample CRF and is therefore often stored in section 8.2.2 and 8.3.2 of the Essential Documents section within ICH-GCP.