Human Research Protection Program Training:

Post-Approval Event Reporting March 26, 2008

Lisa Voss, MPH, CIPAssistant Director, QIU

Human Research Protection Program

Lisa.Voss@ucsf.edu 514-2152

3/26/08

Outline for Today

Roles of the QIU and CHR Types of Post-Approval Events Post-Approval Event Reports Forms Tips Q&A

3/26/08

What is the Role of the QIU?

Provide Quality Assurance (QA) and Quality Improvement (QI) activities

Work with the CHR to assure rights and welfare of human research participants and reduce risk

Front Desk Support GroupAdministrative Assistant IIs

Jessica LoomisMeri Figueroa Mario VelezDenisha Otis

--------------------------TEP for Data Entry

TEP for Filing

HRPP Director Sharon Friend

HRPP Associate Director Education and Screening Unit(Pre-CHR Review Activities)

Richard WagnerAnalyst V Supervisor

HRPP Associate Director CHR Review Unit

(CHR Review Activities) Systems Coordination

John HeldensAnalyst V Supervisor

HRPP Assistant Director Quality Improvement Unit

(Post CHR Approval Activities)Lisa Voss

Analyst V Supervisor

Committee CoordinatorsLaurel Heights

Karen Chao – Analyst IVKate Nolan—Analyst II

Committee CoordinatorsMt. Zion

Michael Thomas -- IVAnnette Bugatto -- II

Committee CoordinatorsParnassus

Liz Tioupine -- IVWendy Stephens -- II

Committee CoordinatorsSFGH

Elizabeth Mendelsohn -- IVTerry Colbert -- II

QIU Group

Maria Bahn – Analyst IVBeth Shields - Analyst IV

TBN – Analyst II

Education and Assessment Group

Joanne Mickalian – Analyst IVAnita Katona – Analyst IV

TBN - Analyst IV

Fred Hendrickson – Analyst IIMegan Sullivan – Analyst II

HRPP Operations Manager TBD

Analyst II Supervisor

HRPP – Human Research Protection ProgramCHR – Committee on Human ResearchQIU – Quality Improvement Unit

3/26/08

QIU Activities

Review post-approval event reports Conduct routine site reviews of

clinical research studies Conduct directed or for cause on-

site reviews of clinical research studies

Emergency Use requests

3/26/08

Post-Approval Event Reports

Adverse Events Protocol Violations Protocol Incidents

Subject or Researcher Concerns and Complaints

Approval Lapses

3/26/08

Post-Approval Event Reports

Investigator Brochure updates Safety Information or Significant New

Finding DSMB/DMC Report Audit Reports Holds on Study Activities Subject Injury Complaints Study Close-Out Reports

Adverse Events (AE’s) and Adverse Events (AE’s) and Serious Adverse Events (SAE’s)Serious Adverse Events (SAE’s)

Determining What To Determining What To Report and What NOT To Report and What NOT To

ReportReport

3/26/08

Adverse Events (Internal)

PI determines event to be: Definitely, Probably, or Possibly Related

AND Serious or Unexpected

Report within 10-working days on Internal AE Reporting Form

3/26/08

Adverse Events (Internal)

Death – Unrelated to research as determined by the PI

Only for interventional studies

Report at time of Renewal or Major Modification via the AE Summary Log

3/26/08

Adverse Events (External)

PI determines that the event: Changes the study risks or benefits

OR Requires a modification to the CHR

Application or the Consent form

Report within 10-working days on External AE Reporting Form

3/26/08

Adverse Events (External)

AE’s that do not meet the previous criteria: Reporting not required by CHR If Sponsors requires reporting use the

AE Summary Log

Protocol ViolationsProtocol Violations

Determining What To Determining What To Report and What NOT To Report and What NOT To

ReportReport

3/26/08

Protocol Violations (Major)

Unapproved changes, deviations, or departures from study design that are: Under the PI’s control and Have not been reviewed and approved by the CHR

AND May affect participants rights, safety or well-being

or impact study data

Report within 10-working days on Violation/Incident Reporting Form

3/26/08

Protocol Violations (Minor)

Also known as Protocol Deviations Unapproved changes, deviations, or

departures from study design that are: Under the PIs control and Have not been reviewed and approved by the

CHRBUT

Do not impact participants rights, safety or well-being or impact study data

Reporting NOT Required – document in study file

Protocol IncidentsProtocol Incidents

Determining What To Determining What To Report and What NOT To Report and What NOT To

ReportReport

3/26/08

Protocol Incidents (Major)

Any problematic or unanticipated event related to: Conduct of the study or subject participation and

involves significant potential harm to the participants.

Subject Complaints

Report within 10-working days on Violation/Incident Reporting Form

3/26/08

Protocol Incidents (Minor)

Any problematic or unanticipated event related to: Conduct of the study or subject participation

and does not involve significant potential harm to the participants.

Subject Complaints

Reporting NOT Required

Other Events and Safety Other Events and Safety InformationInformation

Other ReportsOther Reports

3/26/08

Other Events and Safety Reports

Investigator Drug Brochure Safety Information or Updates DSMB/DMC Reports Audit Reports Hold on Study Activities

Report within 10-working days on Reporting Form

3/26/08

Study Close-Out Reports

Updates CHR on conduct of study since last renewal

Required for: Studies that received full-committee

review at any time Expedited Review studies that

involved participant contact

3/26/08

When NOT to Submit

Do not close-out a study if: local enrollment to the study is ongoing local research-related interventions are

ongoing local participant follow-up is ongoing data analysis or manuscript preparation that

involves use or access to individually identifiable information is ongoing

An IRB approved Tissue Bank is approved under the study

CHR and QIU Role in Post-CHR and QIU Role in Post-Approval Event Reports Approval Event Reports

3/26/08

CHR Review Process

Note report and keep in CHR file Request:

Additional information Require a modification

Flag study for future educational efforts, website guidance, and/or monitoring visits

Temporarily or permanently suspend and terminate enrollment in study

3/26/08

CHR Review Outcome

Determine if the report is an: Unanticipated Problem or Serious or Continuing Non-

Compliance

3/26/08

Unanticipated Problem

An Unanticipated Problem involving risk to participants and or others, is defined on the basis of whether the event is:

Unanticipated or unexpected. Involves risks to participants or others. Related to the research

3/26/08

Serious Noncompliance

Failure to follow state or federal regulations for protection of the rights and welfare of study participants, University policies or the requirements or determinations of the CHR and that, in the judgment of the CHR Chair, Vice Chair, convened CHR Panel or AVC-R, results in, or indicates a potential for:

3/26/08

Serious Noncompliance

a) a significant risk to enrolled or potential participants or others, or

b) compromises the integrity of the study.

3/26/08

Continuing Noncompliance

Pattern of noncompliance that, in the judgment of the CHR Chair, Vice-Chair, convened CHR Panel or the AVC-R, suggests:

the likelihood that instances of noncompliance will continue without intervention.

3/26/08

CHR Regulatory Reporting Requirements

Federal Departments Office for Human Research Protection (OHRP) FDA

SF Veterans Affairs (if VA study) Associate Vice Chancellor for Research UCSF Legal Affairs (in certain cases) Study Sponsor Other offices or groups as required by the

nature of the study

Top Tips and Top Tips and Additional Discussion Points Additional Discussion Points

3/26/08

Tips

Submit reports only once: either by fax or campus mail

Consult with the QIU Identify CHR Approval (H number)

and PI when calling PI must sign all post-approval

event reports

3/26/08

Ask Questions

Ask your PI or Mentor Call the QIU: 415-476-1814 Email QIU: qiu@ucsf.edu http://www.research.ucsf.edu/

chr/