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Subcommittee on Harmonization Report (SOH)
- Subcommittee on Harmonization Report by Mark Barnes and David Forster, SOH Co-Chairs, opens in a new tab (PDF - 694 KB)
- FDA Request for Comments: Clinical Trials Data Sharing by Mark Barnes, J.D., SOH Co-Chair, opens in a new tab (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, opens in a new tab (PDF - 54 KB)
Clustered Randomized Trials and Informed Consent
- Who is a Subject in Professional Cluster Studies by David Forster, J.D., opens in a new tab (PDF - 381 KB)
- Scientific Aspects of Clusters Randomized Trials by Monica Taljaard, PhD, opens in a new tab (PDF - 1,684 KB)
- Ethical Issues in Cluster Randomized Trials in Health Research by Charles Weijer, M.D., Ph.D, opens in a new tab (PDF - 388 KB)
- Challenges in Regulatory Oversight of Cluster Randomized Trials by Bernard Lo, M.D., opens in a new tab (PDF - 169kb)
- SOH Draft Recommendation Regulatory Issues in Cluster Studies, opens in a new tab (PDF - 485 KB)
Certificates of Confidentiality
- An Overview of Certificates of Confidentiality by Ann M. Hardy, Dr., Ph., opens in a new tab (PDF - 1,708 KB)
- DOJ Privacy Certificates by Cheryl Crawford Watson, J.D., opens in a new tab (PDF - 170 KB )
- SOH Draft Recommendation on Certificates of Confidentiality, opens in a new tab (PDF - 222KB)
Subpart A Subcommittee Report (SAS)
- Subpart A Subcommittee Report by David Borasky and Daniel Nelson, SAS Co-Chairs, opens in a new tab (PDF - 5,249KB)
Electronic Informed Consent
- Electronic Informed Consent by David Forster, J.D., MA, CIP, SAS Co-Chair, opens in a new tab (PDF - 641 KB)
- Electronic Informed Consent Perspectives from a Sponsor's Experience by Justin McCarthy, opens in a new tab (PDF - 190 KB)
- Consent and Research Involving Online Health Information by Jeffrey Kahn, PhD, MPH, opens in a new tab (PDF - 245 KB)