Good Clinical Practice (GCP)
Full course · ICH E6(R3) Principles
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Learn the specific regulatory requirements governing investigator communications with the IRB/IEC, including initial submissions, ongoing updates, and prompt reporting of changes that affect trial conduct or participant risk.
The IRB/IEC granted approval. The regulatory binder contains the favorable opinion letter. The site is authorized to begin enrollment.
And now what?
There is a temptation, understandable but dangerous, to treat IRB/IEC approval as a one-time gate to pass through. Obtain the approval, file it, and move on to the real work of enrolling participants and collecting data. This mindset misunderstands the nature of the relationship between investigator and ethics committee.
IRB/IEC oversight is not a gate. It is a partnership. The committee's initial approval was based on information available at that moment. As the trial progresses, new information emerges. The Investigator's Brochure is updated with new safety findings. The consent form requires modification. The protocol is amended. Enrollment patterns differ from projections. Safety signals appear. Personnel change. Equipment fails and is replaced.
Each of these developments may affect the committee's assessment of whether the trial remains ethically acceptable. The committee cannot exercise its oversight function if it does not know what is happening. And the investigator cannot wait for the committee to ask. Section 2.4 of ICH E6(R3) Annex 1 establishes the investigator's affirmative obligations to communicate with the IRB/IEC throughout the trial's duration.
This is, in my experience, where good sites distinguish themselves from adequate ones. Adequate sites file what they must, when they must. Good sites maintain an ongoing dialogue with their ethics committee, anticipating information needs rather than merely reacting to requirements.
What you will learn6 objectives
By the end of this lesson, you will be able to:
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