1. Response to FDA Audit 483 MX-4501N 20100317 114032 3-10: Nine Category 483 Citations Meetings Minutes: Votes for, against, abstention and reason not recorded; controverted [sic: controversial] discussions not summarized Diversity: Meeting convened without a non-scientific member Teleconferencing Participation: Lack of documentation of materials supplied to teleconferencing member Interim Convened Meetings: Lack of documentation of provision for and recording of materials provided at Interim convened meetings Suspension Reporting: A study’s accrual suspension was not reported to the FDA Membership Membership rosters: Lack of documentation of scientific vs. non-scientific designation, affiliate vs. non-affiliate and voting status FDA Audit Citations – March 2010

2. Response to FDA Audit 483 MX-4501N 20100317 114032 3-10: Nine Category 483 Citations (continued) Investigator Responsibilities Investigator Compliance: Compliance by Principal Investigator is not prospectively surveyed Documentation Electronic Recording and Processing: Electronic method not CFR “part 11” compliant; March-April 2008 files missing Serious Adverse Events: Lack of documentation of scientific evaluation when expedited Initial Application and Continuing Review Process: Lack of documentation of application & continuing review processes, particularly of humanitarian devices; and of risk determination FDA Reporting: Suspended, terminated study not reported Informed Consent Forms: Discomforts for venipunctures and mammograms were not included FDA Audit Citations – March 2010

3. FDA Audit Response Actions Completed, June 1 2010 Response to FDA Audit 483 MX-4501N 20100317 114032 3-10: Nine Category 483 Citations Meetings Minutes: Votes for, against, abstention and reason not recorded; controverted [sic: controversial] discussions not summarized Diversity: Meeting convened without a non-scientific member Teleconferencing Participation: Lack of documentation of materials supplied to teleconferencing member Interim Convened Meetings: Lack of documentation of provision for and recording of materials provided at Interim convened meetings Suspension Reporting: A study’s accrual suspension was not reported to the FDA Membership Membership rosters: Lack of documentation of scientific vs. non-scientific designation and of affiliate vs. non-affiliate and voting status

4. Response to FDA Audit 483 MX-4501N 20100317 114032 3-10: Nine Category 483 Citations (continued) Investigator Responsibilities Investigator Compliance: Compliance by Principal Investigator is not prospectively surveyed Documentation Electronic Recording and Processing: Electronic method not CFR “part 11” compliant; March-April 2008 files missing Serious Adverse Events: Lack of documentation of scientific evaluation when expedited Initial Application and Continuing Review Process: Lack of documentation of application & continuing review processes, particularly of humanitarian devices; and of risk determination FDA Reporting: Suspended, terminated study not reported Informed Consent Forms: Discomforts for venipunctures and mammograms were not included FDA Audit Response Actions Completed, June 1 2010

5. MULTI-DISCIPLINARY QUALITY ASSURANCE SUMMARY – August 2010 INDICATOR April 2009 – March 2010 OVERALL STATUS FDA Audit of SCHS IRB March 8-17, 2010 including weekend days 9 “483” citations SCHS IRB-monitored clinical trials open for new subject entry in Central Oregon 42 Different diseases or medical conditions available for clinical trials covered by SCHS IRB 39 Number of patients from Central Oregon accrued to and on clinical trials currently being monitored by the SCHS IRB 921 total; 4/09-3/10: 180 new Number of new clinical trials approved 21 of 23 submitted Number of active clinical trials monitored by SCHS IRB 67 Investigator–initiated clinical trials supported 4 Number of healthcare organizations serviced 11 Number of Principal Investigators and Clinical Research Associates (CRAs) supported 35 MDs &MD/PhDs 14 CRAs Number of inactive clinical trials monitored by SCHS IRB 62

6. QUALITY GOALS GOAL # DESCRIPTION 1 To recruit and retain Central Oregon’s best expertise from both scientific and community professionals to serve on the SCHS IRB and in the IRB office 2 Evaluate and monitor the safety and scientific quality of clinical trials performed within SCHS and Central Oregon for subject safety, maximum individual & societal benefit, effectiveness, timeliness, and equipoise 3 Assure compliance with federal, state, and local regulations of all clinical research involving patients, volunteers, staff and their tissues at SCHS and other sites of responsibility 4 Nurture and support clinicians, clinical research associates, and their supporting staffs in their interest in, and development, conduct, and reporting of, clinical trials 5 Promote clinical and translational research in Central Oregon and enable our community to access the most advanced healthcare opportunities available 6To conduct Goals 1-5 in a fiscally responsible manner (ala the Triple Aim) MULTI-DISCIPLINARY QUALITY ASSURANCE SUMMARY

7. GOAL #3: Comply with federal and state human research regulations Federal Compliance with Code of Federal Regulations related to human research and research protections (45CFR46, 21CFR50, 21CFR56) Successful conduct and completion of FDA, DHHS Office of Human Research Protections (OHRP) requirements, and of sponsor audits State SB 1025: Genetic Testing Opt-Out SB316: Clinical Trial Coverage by Health Insurance Companies

8. GOAL #3: Comply with federal and state human research regulations Process Submission, distribution, review, approval and modification of 1) clinical research applications 2) informed consent, assent and HIPAA forms and revisions 3) protocol amendments and revisions 4) annual continuing renewal applications 5) human device exemptions 6) serious adverse effects (all local and selected study-wide adverse events) 7) protocol deviations and violations 8) accrual suspensions 9) advertising materials 10) investigator brochures 11) sponsor memoranda 12) subject and data confidentiality 13) product information 14) study closures, final reports and publications 15) other changes, communications and directives regarding clinical research Support surveillance and reporting of clinical research activity not being monitored by the IRB