New Research Service Standard Operating Procedures

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New Research Service Standard Operating Procedures

• Kimberly Summers, PharmD
• Assistant Chief for Clinical Research
• South Texas Veterans Health Care System
• Research Development Service

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Standard Operating Procedures

• External Clinical Research Monitoring Visits
• Subject Recruitment and Advertising
• Clinical Impact Statements

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Monitoring By External Agencies

• Entities external to the facility
• Pharmaceutical companies
• Study sponsors
• Contract Research Organizations (CROs)
• VA Cooperative Studies Program Monitors
• Site visits
• Routine
• Conducted for specific cause

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External Clinical Research Monitoring Visits

• VHA Memorandum From Chief Research and
  Development Officer
• Thru Deputy Under Secretary for Health
• Subject Reporting of All Study Site-Monitoring
  Visit Results
• Charge Each research office must develop
  procedures that will ensure all serious findings
  and concerns are appropriately addressed and the
  appropriate facility officials and committees are
  notified

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Research Office Notification

• Findings and issues of concern must be forwarded
  to appropriate facility officials and committees
• This is the responsibility of the Research office
• Component of the STVHCS Human Subjects Protection
  Program (HRPP)
• If no serious findings or concerns are
  identified, the Research office must be notified
  in writing that there were no such findings

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Why is Compliance with this Memorandum Important?

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Office of Research Oversight (ORO)

• Primary VHA office in advising the Under
  Secretary for Health on all matters of compliance
  and assurance including
• Human subject protections
• Animal welfare
• Research safety and security
• Research data security
• Research misconduct
• Oversight is enforced by
• Performing periodic prospective and for-cause
  reviews
• Conducting investigations
• Assuring compliance with the laws, regulations,
  and policies applicable to VHA research.

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Local Example

• Research office unaware of serious issues
  identified by external study monitors for a
  VA-approved research protocol
• Corrective actions were not put into place
• Serious consequences for the institution and
  investigator resulted

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Upon Notice of Monitoring Visit

• Research staff scheduling or confirming the
  monitoring visit must notify the Research office
• For scheduled monitoring visits notification
  should be by email to KimberlyK.Summers_at_va.gov
• For unscheduled monitoring visits notification
  may be by phone [phone] directed to
  Kimberly Summers, Assistant Chief for Clinical
  Research
• Notification should be made as soon as study
  personnel are aware of the visit

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At The Time Of The Monitoring Visit

• Study monitor must sign in at the Research Office
  and receive a visitor badge
• Check-in at Room Q202.1
• A Research Monitor Log will be maintained by the
  Research Office
• Study monitor will be provided
• External Monitor Agreement Form
• Must be reviewed and signed at the time of check
  in
• STVHCS Report of Clinical Research Monitoring
  Visit
• Must be returned to the Research office

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External Research Monitor Log
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Visitor Badges

• Badges will be issued in exchange for a picture
  ID
• Badge must be worn at all times
• Badges must be returned to the Research office by
  430pm
• If monitors will be conducting business past
  430pm they should return to the Research office
  prior to 430 for their state issued ID and the
  responsible investigator or study staff must
  ensure the badge is returned the next business
  day
• Lost or stolen badges will be assessed a 25 fee
  to the responsible investigator
• Monitors assigned the visitor badge must be
  accompanied by a VA employee (paid or WOC)

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• Completion is required independent of the
  findings associated with the visit

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Findings That Require an Exit Interview

• Suspicions or concerns that serious
  non-compliance may exist
• All findings of serious non-compliance with study
  protocol, IRB requirements or applicable
  regulations and policies
• Monitoring visits conducted by regulatory
  agencies (FDA, OHRP)

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Compliance With External Clinical Research
Monitoring Policies and SOPs

• STVHCS Compliance Office
• Will verify results of external clinical research
  monitoring visits were reported to the RD Office
• Component of routine monitoring of investigator
  records
• Office of Research Oversight (ORO)
• May perform periodic prospective and for-cause
  reviews to assure compliance with the laws,
  regulations, and policies applicable to VHA
  research
• STVHCS Police
• Will audit appropriate security measures are in
  place for all visitors related to research
• Will audit check-in and assignment of badges

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Human Subjects Clinical Research Recruitment and
Advertising

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Recruitment

• Researcher Contact with Veterans
• VHA Memorandum 7/10/06
• IRB-approved mechanisms
• Physician referral
• Posting of IRB-approved advertisements
• Preparatory to Research by HIPAA Privacy Rule
• VA guidelines are more restrictive

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Researcher Contacts with Veterans
7/10/06 Principal Deputy Under Secretary for
Health Memorandum

• All non-essential contact of veterans must stop
• Clinically essential contact that cannot be
  deferred is allowed
• Contact shall not solicit sensitive information
• Contact by researchers and study staff must be
  limited to procedures and data elements outlined
  in IRB and RD approved protocols
• During recruitment
• Initial contact must be in person and/or by
  letter
• A telephone number must be provided for the
  veteran to verify the validity of the study
• http//www.clinicaltrials.gov/ website may be
  provided
• Following recruitment and during follow-up
• All telephone calls should begin by referring to
  previous contacts and information provided in the
  informed consent document

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Physician Referral

• Veteran patients may be formally referred from VA
  staff for a VA-approved research protocol
• Veteran patients may NOT be formally referred
  from VA staff to off-site locations for non-VA
  approved research protocols
• Veteran patients have a right to seek care from
  and enroll in research studies outside the VA
• Informing veteran patients of the availability of
  an outside research study is not considered a
  referral, if the referring physician will not
  have ongoing participation in the care of the
  patient

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Informing Veterans About Off-site Non-VA
Research Studies

• Veterans must be informed that VA will not be
  responsible for any costs related to their care
  as part of the off-site research
• Enrollment should occur through the veterans own
  initiative in contacting the study personnel at
  the off-site institution
• Provision of information to a veteran regarding
  off-site research and their associated
  responsibility for cost should be documented by
  the VA physician in a progress note in CPRS
• VA records may not be accessed to obtain
  information for research purposes of a non-VA
  off-site study

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Recruitment Advertisements Posted at the STVHCS

• Steps required
• Approved and stamped by UTHSCSA IRB
• Verification of active protocol and stamped by VA
  Research Office
• Posting approval by VA Public Affairs Office
• Recruitment of VA patients into non-VA studies
  through posted advertisements in NOT allowed

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Expedited Posting

• Following IRB approval Investigator or study
  staff may hand deliver advertisement
• RD office
• RM Q202
• Will verify study approval and stamp
• Public Affairs office
• RM 118
• Will approve and stamp for posting
• May be posted same day

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Preparatory to Research

• Review of individually-identifiable information
  by a VA investigator to prepare a research
  protocol does not require IRB or RD approval
• Examples to generate a hypothesis, determine
  feasibility to conduct a study, determine the
  number of eligible patients
• In the VA, using individually-identifiable
  information to contact potential research
  subjects as part of recruitment into a research
  protocol is NOT considered preparatory to
  research
• VA regulations differ from those described in the
  HIPAA Privacy Rule
• IRB and RD Committee review and approval
  required
• IRB approved waiver of authorization and waiver
  of informed consent required
• Pilot studies are NOT considered part of the
  activities preparatory to research
• IRB and RD Committee review and approval
  required

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Statement of Clinical Impact Forms

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RD Committee Review of Research

• The RD Committee must evaluate the availability
  of adequate resources to conduct and complete the
  research
• Clinical hospital services must be notified if
  their services are required in order to conduct a
  research project
• Each affected service must verify resources
  within their respective service are adequate to
  conduct and complete the research project

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Statement of Clinical Impact

• Radiology Service
• Nuclear Medicine Service
• Nursing Service
• Pharmacy Service
• Pathology and Laboratory Service
• Other Hospital Service

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• Electronic form available on Research website
• Items 1-7. All fields are required. Information
  entered on page 1 will be auto filled on pages 2
  through 6.
• Item 8. Complete the applicable table for each
  VA Service that will be utilized as part of your
  project.

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Routing Statement of Clinical Impact Forms

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• Submit completed forms via email to
  stxresearch_at_va.gov
• If you have any questions completing the form
• Contact Angela Casas in the Research office at
  [phone] x 15523
• The Research office will forward completed forms
  to the appropriate VA Services for signatures
• An electronic signed copy will be provided for
  your records
• If project requirements change for any VA
  Service, a revised form must be submitted to the
  Research office

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Questions?

• Kimberly Summers, PharmD
• Office [phone] ext 15969
• Email kimberlyk.Summers_at_va.gov