- The sponsor should inform investigators/institutions, regulatory authorities, and IRBs/Ethics Committees of any early termination or suspension of the study. This step was included in the Investigator Responsibilities section of R2 and R3; presumably it is repeated here so it is clear that it is a sponsor responsibility.
- For all studies, sponsors should provide investigators with a summary of trial results. This requirement is also referenced in the End of Participation in a Clinical Trial section in R3.
- For all studies, sponsors should "consider" giving investigators information about their patients' treatment assignments. The word choice is interesting, because other sections of R3 (informed consent and end of participation) reference the sponsor's provision of treatment assignments to the investigator and the investigator's provision to participants. The Clinical Trial/Study Reports section states that "where...information is provided to participants," it should be provided only after unblinding and relevant analyses are completed, and language should be easily understandable and non-promotional
What's New in E6 R3? Sponsor Responsibilities, Part 10 - Clinical Trial/Study Reports
Denise Lacey
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The last Sponsor Responsibilities section in ICH GCP E6 R3 deals with Clinical Trial/Study Reports. This short section has been divided into two steps, one for prematurely terminated studies, the second applying to all studies. There is not much new here, but several sponsor requirements from the Investigator Responsibilities section of R3 have been repeated in this section.
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