The RC-CRC boundary is, in my experience, where more regulatory errors originate than at any other handoff point in the site's operation. Not because CRCs are careless -- they are, as a group, among the most conscientious professionals in clinical research. And not because RCs fail to communicate -- most communicate constantly. The errors originate because the boundary itself is poorly designed. Tasks are divided by custom rather than by analysis. Handoffs rely on assumptions rather than documentation. Oversight is either absent or suffocating, rarely calibrated.

Here is the core principle: the delegation framework between the RC and the CRC is something you design. It is not inherited from the previous RC. It is not dictated by "how we have always done it." It is not improvised study by study. Under ICH E6(R3) Annex 1, Section 2.3.2, the investigator must ensure that individuals to whom tasks are delegated are qualified by education, training, and experience. Under Section 2.3.3, the investigator must maintain a record of delegation documenting persons to whom trial-related activities have been delegated, proportionate to the significance of those activities. As the person who operationalizes these requirements at portfolio scale, the RC is the architect of how regulatory work flows between roles -- what gets delegated, what gets retained, what gets checked, and what documentation travels with each handoff.

The RC-CRC boundary is, in my experience, where more regulatory errors originate than at any other handoff point in the site's operation. Not because CRCs are careless -- they are, as a group, among the most conscientious professionals in clinical research. And not because RCs fail to communicate -- most communicate constantly. The errors originate because the boundary itself is poorly designed. Tasks are divided by custom rather than by analysis. Handoffs rely on assumptions rather than documentation. Oversight is either absent or suffocating, rarely calibrated.

Here is the core principle: the delegation framework between the RC and the CRC is something you design. It is not inherited from the previous RC. It is not dictated by "how we have always done it." It is not improvised study by study. Under ICH E6(R3) Annex 1, Section 2.3.2, the investigator must ensure that individuals to whom tasks are delegated are qualified by education, training, and experience. Under Section 2.3.3, the investigator must maintain a record of delegation documenting persons to whom trial-related activities have been delegated, proportionate to the significance of those activities. As the person who operationalizes these requirements at portfolio scale, the RC is the architect of how regulatory work flows between roles -- what gets delegated, what gets retained, what gets checked, and what documentation travels with each handoff.