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;

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


(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

FDA Audit Response Actions Completed, June 1 2010


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


(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

MULTI-DISCIPLINARY QUALITY ASSURANCE SUMMARY – August 2010

INDICATOR April 2009 – March 2010

OVERALL STATUS

FDA Audit of SCHS IRBMarch 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 onclinical 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/PhDs14 CRAs

Number of inactive clinical trials monitored by SCHS IRB 62

QUALITY GOALSGOAL

# DESCRIPTION

1To 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

2Evaluate 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

3Assure 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

4Nurture and support clinicians, clinical research associates, and their supporting staffs in their interest in, and development, conduct, and reporting of, clinical trials

5Promote clinical and translational research in Central Oregon and enable our community to access the most advanced healthcare opportunities available

6 To conduct Goals 1-5 in a fiscally responsible manner (ala the Triple Aim)

MULTI-DISCIPLINARY QUALITY ASSURANCE SUMMARY

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

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 materials10) investigator brochures11) sponsor memoranda12) subject and data confidentiality13) product information14) study closures, final reports and publications15) other changes, communications and directives regarding clinical research

• Support surveillance and reporting of clinical research activity not being monitored by the IRB

Documents

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;