The investigator-coordinator relationship: delegation, accountability, and ICH E6(R3) Section 2.3
Understand the regulatory framework governing task delegation from investigator to coordinator, identify the bright lines between delegable and non-delegable activities, and apply a decision framework when delegation boundaries are ambiguous.
A lab value and a question
It is a Thursday afternoon during a screening visit. The coordinator pulls up the participant's chemistry panel and sees a serum creatinine of 1.6 mg/dL. The protocol's inclusion criterion reads: "estimated glomerular filtration rate (eGFR) greater than or equal to 60 mL/min/1.73m2." The coordinator calculates the eGFR using the CKD-EPI equation and arrives at 58 mL/min/1.73m2--two points below the threshold.
The participant is sitting in the exam room. She took the morning off work to be here. She is eager to enroll. The principal investigator is in the operating room and will not be available for at least three hours.
Can the coordinator screen this participant out? Can the coordinator screen her in? Can the coordinator tell the participant anything at all about her eligibility status?
The answer to every one of these questions depends on a single document: the delegation log. And the answer is almost certainly no--not because the coordinator lacks the intelligence to interpret a lab value, but because determining whether a participant meets medical eligibility criteria is a medical decision, and medical decisions belong to the investigator. This distinction--between what a coordinator can do and what a coordinator may do under the regulatory framework--is the foundation of the investigator-coordinator relationship.
This lesson is about that foundation. It is about delegation: what it means, what governs it, where the lines are drawn, and what to do when you find yourself standing on one of those lines at 3:00 p.m. on a Thursday with a participant waiting and a principal investigator who is unreachable.
What you will learn
By the end of this lesson, you will be able to: