Today in changes from draft to final ICH GCP E6 R3, we consider sponsor responsibilities for IMP. This section really spotlights the proliferation of the parenthetical plural. It contains dozens of references to "investigational product(s)," "active control(s)," "Investigator(s)," "Institution(s)," and "authority(ies)." We get it - there could be one or more than one - but that's true of almost any noun in the guideline. The Chicago Manual of Style doesn't like it, and neither do we. On to the updates, including some substantive additions:
In section 3.15.2, Manufacturing, Packaging, Labelling, and Coding Investigational Product(s), step (d), regarding sponsor responsibilities for blinded trials, now states that sponsors should implement a process to blind "individuals, including sponsor staff, trial participants, investigator and/or investigator site staff" to IP identity and treatment assignments. This wording is more inclusive than the draft "sponsor staff, trial participant and/or investigator," recognizing that other individuals are also blinded/masked.
In section 3.15.3, Supplying and Handling Investigational Product(s), step (a) concerning direct supply of IP to study participants now adds the following details: "Various approaches for shipping and dispensing may be undertaken, for example, by taking into consideration the characteristics of the investigational products, the route and complexity of administration and the level of existing knowledge about the investigational product’s safety profile. Investigational product management should be arranged and conducted in accordance with applicable regulatory requirements, and safeguards should be in place to ensure product integrity, product use per protocol and participant safety.”
In the same section, step (c)(vi) regarding sample retention has been changed from "The samples do not need to be kept by the sponsor in trials where an authorized medical product is used as an investigational product unmodified from its authorized state" to "The samples may not need to be kept by the sponsor in trials where an authorized medical product is used as an investigational product unmodified from its authorized state in accordance with local regulatory requirements. In this situation, samples are typically kept by the manufacturer."
