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Subcommittee on Harmonization Report (SOH)
- Subcommittee on Harmonization Report by Mark Barnes and David Forster, SOH Co-Chairs (PDF - 694 KB)
- FDA Request for Comments: Clinical Trials Data Sharing by Mark Barnes, J.D., SOH Co-Chair (PDF - 273 KB)
- SOH Comment regarding the June 4, 2013 FDA Request for Comment relating to the availability of masked and de-intentified non-summary safety and efficacy data (PDF - 54 KB)
Clustered Randomized Trials and Informed Consent
- Who is a Subject in Professional Cluster Studies by David Forster, J.D. (PDF - 381 KB)
- Scientific Aspects of Clusters Randomized Trials by Monica Taljaard, PhD (PDF - 1,684 KB)
- Ethical Issues in Cluster Randomized Trials in Health Research by Charles Weijer, M.D., Ph.D (PDF - 388 KB)
- Challenges in Regulatory Oversight of Cluster Randomized Trials by Bernard Lo, M.D. (PDF - 169kb)
- SOH Draft Recommendation Regulatory Issues in Cluster Studies (PDF - 485 KB)
Certificates of Confidentiality
- An Overview of Certificates of Confidentiality by Ann M. Hardy, Dr., Ph. (PDF - 1,708 KB)
- DOJ Privacy Certificates by Cheryl Crawford Watson, J.D. (PDF - 170 KB )
- SOH Draft Recommendation on Certificates of Confidentiality (PDF - 222KB)
