Which of the following identifies content that should be included in a clinical research protocol?

Theprotocolmust provide scientific rationale, including prior nonclinical findings that justify human research.

ICH E6(R2) 6.2.2:“The protocol should include… a summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial.”

Other listed options belong elsewhere:

IRB approvals (A) are separate administrative records.

SOPs for data collection (B) are sponsor-level procedural documents.

Investigator selection (C) is a sponsor’s responsibility, not protocol content.

Thus, the correct answer isD (Summary of nonclinical findings with clinical relevance).