SACHRP July 10-11, 2013 Presentation Materials

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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)

Subpart A Subcommittee Report (SAS)

• Subpart A Subcommittee Report by David Borasky and Daniel Nelson, SAS Co-Chairs (PDF - 5,249KB)

Electronic Informed Consent

• Electronic Informed Consent by David Forster, J.D., MA, CIP, SAS Co-Chair (PDF - 641 KB)
• Electronic Informed Consent Perspectives from a Sponsor's Experience by Justin McCarthy (PDF - 190 KB)
• Consent and Research Involving Online Health Information by Jeffrey Kahn, PhD, MPH (PDF - 245 KB)