Comment from CDISC Protocol Deviation Sub-Team
AnonymousSupportAdvocacy
Summary: The CDISC Protocol Deviation Sub-Team recommends updating the examples of "related plans and procedures" in the draft guidance to include documents like laboratory and pharmacy manuals. They argue that monitoring plans and statistical analysis plans describe sponsor actions rather than site-level activities, and thus should not be categorized as protocol components in this context.
An additional comment is provided by the CDISC Protocol Deviation Sub-Team in addition to the comments sent in m7o-nnsp-xeg5.
In footnote 2 “In this guidance, the term protocol encompasses both written protocols and their related plans and procedures (e.g., monitoring plan, statistical analysis plan).” please consider updating the “related plans and procedures” examples that are provided in the brackets from “(e.g. monitoring plan, statistical analysis plan)” to other examples like “(e.g. laboratory manual, pharmacy manual, eCOA/IRT guidance documents)”.
The CDISC Protocol Deviation sub-team’s recommendation is that Monitoring Plans and the SAP do not further describe activities for the site to perform to support the protocol but describe actions that the sponsor performs e.g. the SAP describes the analysis of trial data.
The pharmacy manual can include information on the management of IMP temperature excursions by the site which can be included as Important (or Non-Important) protocol deviations. A deviation from the monitoring plan e.g. the CRA did not perform 100% Source Data Verification as required would not lead to a protocol deviation but a separate quality issue possibly managed by a sponsor/CRO CAPA.