We are in the home stretch! Today, I learned that this expression is derived from horse racing and not, as I always thought, from baseball. I must have conflated "home run" and "seventh inning stretch." Funny how the brain works! At any rate, the last section in the Sponsor Responsibilities part of ICH GCP E6 R3 is 3.17.2 Clinical Trial/Study Reports. There are two significant changes from the May 2023 draft to the January 2025 final version:  

Step (b) regarding the consideration of coordinating investigators as signatories has been moved from the Investigator Responsibilities section to this section. 

Step (c), which previously stated that sponsors should "give consideration" to providing the investigator with information about treatment assignments, now more plainly states that after the trial is completed, the sponsor should "make trial results publicly available" (a new requirement here, but reiterating the principles section) and provide the investigator with treatment assignments and results. These steps should be performed "in accordance with applicable regulatory requirements."

Next, we'll look at changes to the IB and Protocol sections.