New Research Service Standard New Research Service Standard Operating ProceduresOperating Procedures

Kimberly Summers, PharmDKimberly Summers, PharmDAssistant Chief for Clinical ResearchAssistant Chief for Clinical Research

South Texas Veterans Health Care SystemSouth Texas Veterans Health Care SystemResearch & Development ServiceResearch & Development Service

Standard Operating ProceduresStandard Operating Procedures

• External Clinical Research Monitoring External Clinical Research Monitoring

VisitsVisits

• Subject Recruitment and AdvertisingSubject Recruitment and Advertising

• Clinical Impact StatementsClinical Impact Statements

Monitoring By External AgenciesMonitoring By External Agencies

• Entities external to the facilityEntities external to the facility– Pharmaceutical companiesPharmaceutical companies– Study sponsorsStudy sponsors– Contract Research Organizations (CROs)Contract Research Organizations (CROs)– VA Cooperative Studies Program MonitorsVA Cooperative Studies Program Monitors

• Site visitsSite visits– RoutineRoutine– Conducted for specific causeConducted for specific cause

External Clinical Research External Clinical Research Monitoring VisitsMonitoring Visits

• VHA Memorandum From Chief Research VHA Memorandum From Chief Research and Development Officerand Development Officer– Thru Deputy Under Secretary for HealthThru Deputy Under Secretary for Health– Subject: Reporting of All Study Site-Subject: Reporting of All Study Site-

Monitoring Visit ResultsMonitoring Visit Results– Charge: Each research office must develop Charge: Each research office must develop

procedures that will ensure all serious findings procedures that will ensure all serious findings and concerns are appropriately addressed and concerns are appropriately addressed and the appropriate facility officials and and the appropriate facility officials and committees are notified committees are notified

Research Office Notification Research Office Notification

• Findings and issues of concern must be Findings and issues of concern must be forwarded to appropriate facility officials and forwarded to appropriate facility officials and committeescommittees– This is the responsibility of the Research officeThis is the responsibility of the Research office– Component of the STVHCS Human Subjects Component of the STVHCS Human Subjects

Protection Program (HRPP)Protection Program (HRPP)

• If no serious findings or concerns are identified, If no serious findings or concerns are identified, the Research office must be notified in writing the Research office must be notified in writing that there were no such findings that there were no such findings

Why is Compliance with this Memorandum Important?

Office of Research Oversight (ORO)

• Primary VHA office in advising the Under Secretary for Primary VHA office in advising the Under Secretary for Health on all matters of compliance and assurance Health on all matters of compliance and assurance including:including:– Human subject protectionsHuman subject protections– Animal welfareAnimal welfare– Research safety and securityResearch safety and security– Research data securityResearch data security– Research misconductResearch misconduct

• Oversight is enforced by:Oversight is enforced by:– Performing periodic prospective and for-cause reviewsPerforming periodic prospective and for-cause reviews– Conducting investigationsConducting investigations– Assuring compliance with the laws, regulations, and policies Assuring compliance with the laws, regulations, and policies

applicable to VHA research. applicable to VHA research.

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

Upon Notice of Monitoring VisitUpon Notice of Monitoring Visit• Research staff scheduling or confirming the Research staff scheduling or confirming the

monitoring visit must notify the Research officemonitoring visit must notify the Research office– For scheduled monitoring visits notification should be For scheduled monitoring visits notification should be

by email to by email to KimberlyK.Summers@va.gov– For unscheduled monitoring visits notification may be For unscheduled monitoring visits notification may be

by phone (210) 617-5123 directed to Kimberly by phone (210) 617-5123 directed to Kimberly Summers, Assistant Chief for Clinical ResearchSummers, Assistant Chief for Clinical Research

• Notification should be made as soon as study Notification should be made as soon as study personnel are aware of the visitpersonnel are aware of the visit

At The Time Of The Monitoring VisitAt The Time Of The Monitoring Visit

• Study monitor must sign in at the Research Study monitor must sign in at the Research Office and receive a visitor badgeOffice and receive a visitor badge– Check-in at Room Q202.1Check-in at Room Q202.1– A Research Monitor Log will be maintained by the A Research Monitor Log will be maintained by the

Research OfficeResearch Office

• Study monitor will be provided Study monitor will be provided – External Monitor Agreement FormExternal Monitor Agreement Form

• Must be reviewed and signed at the time of check inMust be reviewed and signed at the time of check in

– STVHCS Report of Clinical Research Monitoring VisitSTVHCS Report of Clinical Research Monitoring Visit• Must be returned to the Research officeMust be returned to the Research office

External Research Monitor Log

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

4:30pm – If monitors will be conducting business past 4:30pm they should

return to the Research office prior to 4:30 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)

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

Findings That Require an Exit InterviewFindings That Require an Exit Interview

• Suspicions or concerns that serious non-Suspicions or concerns that serious non-compliance may existcompliance may exist

• All findings of serious non-compliance with All findings of serious non-compliance with study protocol, IRB requirements or study protocol, IRB requirements or applicable regulations and policiesapplicable regulations and policies

• Monitoring visits conducted by regulatory Monitoring visits conducted by regulatory agencies (FDA, OHRP)agencies (FDA, OHRP)

Compliance With External Clinical Compliance With External Clinical

Research Monitoring Policies and SOPsResearch Monitoring Policies and SOPs

• STVHCS Compliance Office STVHCS Compliance Office – Will verify results of external clinical research monitoring visits Will verify results of external clinical research monitoring visits

were reported to the R&D Officewere reported to the R&D Office– Component of routine monitoring of investigator recordsComponent of routine monitoring of investigator records

• Office of Research Oversight (ORO)Office of Research Oversight (ORO)– May perform periodic prospective and for-cause reviews to May perform periodic prospective and for-cause reviews to

assure compliance with the laws, regulations, and policies assure compliance with the laws, regulations, and policies applicable to VHA researchapplicable to VHA research

• STVHCS PoliceSTVHCS Police– Will audit appropriate security measures are in place for all Will audit appropriate security measures are in place for all

visitors related to researchvisitors related to research– Will audit check-in and assignment of badgesWill audit check-in and assignment of badges

Human Subjects Clinical Human Subjects Clinical Research Recruitment and Research Recruitment and

AdvertisingAdvertising

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

Researcher Contacts with Veterans

• 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 R&D 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

7/10/06 Principal Deputy Under Secretary for Health Memorandum

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

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

Recruitment Advertisements Recruitment Advertisements Posted at the STVHCSPosted at the STVHCS

• Steps requiredSteps required

– Approved and stamped by UTHSCSA IRBApproved and stamped by UTHSCSA IRB

– Verification of active protocol and stamped by VA Verification of active protocol and stamped by VA

Research Office Research Office

– Posting approval by VA Public Affairs OfficePosting approval by VA Public Affairs Office

• Recruitment of VA patients into non-VA studies Recruitment of VA patients into non-VA studies through posted advertisements in NOT allowedthrough posted advertisements in NOT allowed

Expedited PostingExpedited Posting

• Following IRB approval Investigator or study Following IRB approval Investigator or study staff may hand deliver advertisement staff may hand deliver advertisement – R&D officeR&D office

• RM Q202RM Q202• Will verify study approval and stampWill verify study approval and stamp

– Public Affairs officePublic Affairs office• RM 118RM 118• Will approve and stamp for postingWill approve and stamp for posting

– May be posted same dayMay be posted same day

“Preparatory to Research”

• Review of individually-identifiable information by a VA investigator to prepare a research protocol does not require IRB or R&D 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 R&D 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 R&D Committee review and approval required

Statement of Clinical Impact Statement of Clinical Impact FormsForms

R&D Committee Review of Research

• The R&D 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

Statement of Clinical ImpactStatement of Clinical Impact

• Radiology Service

• Nuclear Medicine Service

• Nursing Service

• Pharmacy Service

• Pathology and Laboratory Service

• Other Hospital Service

• Electronic form Electronic form available on available on Research websiteResearch website

• Items 1-7Items 1-7. All . All fields are required. fields are required. Information Information entered on page 1 entered on page 1 will be auto filled will be auto filled on pages 2 through on pages 2 through 6. 6.

• Item 8Item 8. Complete . Complete the applicable table the applicable table for each VA for each VA Service that will be Service that will be utilized as part of utilized as part of your project.your project.

Routing Statement of Clinical Routing Statement of Clinical Impact FormsImpact Forms

  

• Submit completed forms via email to Submit completed forms via email to stxresearch@va.gov

• If you have any questions completing the formIf you have any questions completing the form– Contact Angela Casas in the Research office at (210)617-5300 x Contact Angela Casas in the Research office at (210)617-5300 x

1552315523

• The Research office will forward completed forms to the The Research office will forward completed forms to the appropriate VA Services for signatures appropriate VA Services for signatures

• An electronic signed copy will be provided for your An electronic signed copy will be provided for your recordsrecords

• If project requirements change for any VA Service, a If project requirements change for any VA Service, a revised form must be submitted to the Research office revised form must be submitted to the Research office

Questions?Questions?

Kimberly Summers, PharmDKimberly Summers, PharmD

Office: (210) 617-5300 ext 15969Office: (210) 617-5300 ext 15969

Email: kimberlyk.Summers@va.govEmail: kimberlyk.Summers@va.gov