Guidance for Industry: Computerized Systems Used in Clinical Trials (May 10, 2007)

ICH E6: Good Clinical Practice: Consolidated Guideline 
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.

Federal Register: 62 FR 25691 (May 9,1997)

ICH E5: Ethnic Factors in the Acceptability of Foreign Clinical Data
This International Conference on Harmonization (ICH) document makes recommendations for strategies to permit clinical data collected in one region to be used to support drug and biologic registrations in another region while allowing for the influence of ethnic factors.

Federal Register: 63 FR 31790 (June 10, 1998)

Information Sheet Guidances: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

Comprehensive List of CDER Guidances