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Multiple Choice

What was the date of the first approval of the original E6 Guideline?

The key point is knowing the historical moment when the Good Clinical Practice standard, E6, was first approved. The original E6 Guideline was approved on 27 April 1995. This date marks the moment when ICH established harmonized rules for how trials should be designed, conducted, and reported to protect participants and ensure reliable data across regions. Later revisions built on this foundation, but the official first-approval date is 27 April 1995, which is why it’s the correct choice. The other dates don’t align with the official record of the guideline’s inception.

The key point is knowing the historical moment when the Good Clinical Practice standard, E6, was first approved. The original E6 Guideline was approved on 27 April 1995. This date marks the moment when ICH established harmonized rules for how trials should be designed, conducted, and reported to protect participants and ensure reliable data across regions. Later revisions built on this foundation, but the official first-approval date is 27 April 1995, which is why it’s the correct choice. The other dates don’t align with the official record of the guideline’s inception.