Attachment 1 PWS GCP Monitoring.docx

Performance Work Statement with Quality Assurance Surveillance Plan Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services New Mexico Veterans Affairs Health Care System (NMVAHCS)

1.0 Introduction: This requirement is for Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services.

2.0 Background:

2.1 The Department of Veterans Affairs (VA), Cooperative Studies Program (CSP), Site Monitoring, Auditing and Resource Team (SMART) requires a Requirements contract for Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) monitoring services for clinical trials conducted by or requested by CSP. Trials are conducted at VA facilities and associated non-VA facilities throughout the United States and vary over time in number, size, and design. At any given time, CSP will have approximately 25 trials ongoing involving 300 to 400 investigative sites in various stages of activities (planning, on-going, closeout) but typically between 8 to 12 trials are actively monitored each fiscal year.

2.2 SMART, co-located with the CSP Clinical Research Pharmacy Coordinating Center (CSPCRPCC) in Albuquerque, New Mexico and tenant to the New Mexico Veterans Affairs Health Care System (NMVAHCS) is responsible for ensuring VA CSP clinical trials are conducted in compliance with the scientific and ethical principles embodied in the GCP regulations and guidelines. SMART accomplishes this task by training VA personnel conducting/supporting clinical trials in GCP and identifying any compliance problems at participating research sites and resolved through a program of CRQA site visits (both on-site and virtual/remote off-site monitoring techniques are utilized).

2.3 The VA SMART program does not have the required manpower authorized or assigned to support the full workload and relies on experienced contracted monitoring service to fulfill program requirements.

3.0 Applicable References

3.1 VHA Directive 1200.01 Research and Development Committee

3.2 VHA Directive 1200.05(3) Requirements for the Protection of Human Subjects in Research

3.3 VHA Handbook 1108.04 Investigational Drugs and Supplies

3.4 VHA Directive 1058.01 Research Compliance Reporting Requirements

3.5 VHA Directive 1907.01 Health Information Management and Health Records

3.6 45 CFR 46 – Protection of Human Subjects

3.7 38 CFR 16 Protection of Human Subjects – (VA Common Rule)

3.8 ICH E6 (R2) – International Council for Harmonization (ICH) Guidelines – Good Clinical Practice

3.9 FDA Regulations (e.g. 21 CFR 312 Investigational New Drug Application; 21 CFR 812)

3.10 FDA Form 1572 requirements and guidance

3.11 CSP Investigator Guidelines

3.12 CSP Program level Global Standard Operating Procedures (SOPs)

3.13 CSP Study Protocol and Operations Manuals

3.14 SMART SOPs and Approved Methods and Procedures (AMPs)

4.0 General Scope

4.1 The Contractor shall provide services for Clinical Research Quality Associate (CRQA) services to the Site Monitoring, Auditing and Resource Team (SMART). Also, to provide as many as needed to fulfill the contract. The contractor shall inspect a clinical trial site using a clinical trial specific monitoring plan developed and provided by the Chief of Monitoring or designee. The tasks include performing on-site (in-person with travel required or a virtual equivalent with no travel required) and off-site (remote review of key critical data) visits, providing post-visit reports, and providing GCP Program Quality Support (PQS) following SMART guidelines. Monitoring schedules are based on the studies current at the time and their projected status but are subject to changes. The monitoring plan will be compliant with the standards/references (or as amended / deleted by the government) provided in section 3.0 which the contract monitor is expected to have familiarity.

4.2 When required and ordered via task order the contractor will identify specific SMART, monitor(s) to fulfill the role of CRQA for studies within 30 days of notification.

5.0 Specific Requirements: These inspections can be off-site (remote) or on-site and the location will be identified via email or phone notification from SMART.

5.1 [CLIN 0001, 1001, 2001] Task 1 – CRQA visits with pre and post work, (INCLUDES PORTAL-TO-PORTAL TRAVEL TIME)

5.1.1 The contractor shall conduct site initiation visits as defined by the CRQA Monitoring Plan and SMART Standard Operating Procedures (SOPs) with the support of the Lead CRQA. The specific monitoring plan will be referenced in the individual task order.

5.1.1.1 The visits shall be scheduled after the Investigator’s Meeting.

5.1.1.2 When conducting a site initiation visit, the CRQA shall perform an evaluation as specified in the CRQA Monitoring Plan that will include a minimum of the following, and additional items as relevant to the design of the trial:

5.1.1.2.1 Protocol procedures including inclusion/exclusion criteria

5.1.1.2.2 Subject informed consent process

5.1.1.2.3 Screening procedure

5.1.1.2.4 Randomization procedure

5.1.1.2.5 Investigational Product Accountability

5.1.1.2.6 Unanticipated Adverse Event reporting and Serious Adverse Event Reports

5.1.1.2.7 Source document review and verification

5.1.1.2.8 Current requirements and availability

5.1.1.2.9 Case Report Form (CRF) completion, correction, QA procedures

5.1.1.2.10 Institutional Review Board (IRB) policies and procedures (i.e., adverse events and protocol deviations)

5.1.1.2.11 Regulatory and other study document completion and maintenance

5.1.1.2.12 Site correspondence with sponsor, CRQA and maintenance

5.1.1.2.13 Un-blinding procedures of a blinded study

5.1.1.2.14 Other related protocol procedures

5.1.1.3 The contractor shall assure the following regulatory information is present in the site files:

5.1.1.3.1 Current IRB approval – protocol/amendments

5.1.1.3.2 Current IRB approval – consents(s)

5.1.1.3.3 Current IRB membership list or documentation of IRB compliance

5.1.1.3.4 Investigator agreements

5.1.1.3.5 Financial disclosures

5.1.1.3.6 Investigator curriculum vitae (CV)

5.1.1.3.7 Research and indemnity (if applicable) agreement

5.1.1.3.8 All training requirements – GCP, Health Insurance Portability and Accountability Act (HIPAA) and Human Subjects Protections (HSP)

5.1.1.4 The contractor shall ensure the following Study Management Documents are completed (if applicable) and appropriately filed in the Essential Document Binder (Regulatory Binder):

5.1.1.4.1 Delegation of Authority Form or CRF Authorization Log

5.1.1.4.2 IRB policy and procedures (i.e., adverse event and protocol deviation reporting)

5.1.1.4.3 IRB correspondence

5.1.1.4.4 Sponsor correspondence

5.1.1.4.5 Study contacts list

5.1.1.4.6 Subject list

5.1.1.4.7 Site Visit Log

5.1.1.4.8 CRFs (all versions)

5.1.1.4.9 CVs

5.1.2 [CLIN 0001, 1001, 2001] - Subtask 1b – Conduct Routine Monitoring Visits - one to four days (with pre and post work, (INCLUDES PORTAL-TO-PORTAL TRAVEL TIME)

5.1.2.1 The contractor shall conduct periodic routine visits per the CRQA Plan and SMART Standard Operating Procedures (SOPs) to inspect VA investigators for compliance with GCP and with VA and CSP Research policies. The Government’s expectation is the contractor will hire the appropriate number of employees to fulfill the requirement.

5.1.2.1.1 Frequency of Visits – The frequency and timing of contractor visits will be determined by SMART Leadership for each site based on the following:

5.1.2.1.1.1 Lead CRQA and Study Team recommendations

5.1.2.1.1.2 Subject accrual rate at the site

5.1.2.1.1.3 Total number of subjects to be enrolled at the site

5.1.2.1.1.4 Complexity and risk level of the study protocol

5.1.2.1.1.5 Data collection and record keeping proficiency at the site

5.1.2.1.1.6 Observations and corrective actions from previous monitoring visits

5.1.3 [CLIN 0001, 1001, 2001] Subtask 1c – Preparing for Site Visits

5.1.3.1 Scheduling –After approval of planned visit by monitoring study Lead, the contractor shall coordinate visit dates with site Study Coordinator and Site Investigator.

5.1.3.1.1 The contractor will receive contact information and mailing address via issued via email.

5.1.3.1.2 The contractor shall contact the site coordinator directly to set up a date/time for the visit and to discuss:

5.1.3.1.2.1 Tentative Agenda (developed by Contractor)

5.1.3.1.2.2 Estimated time needed on site with the Site Investigator/Coordinator

5.1.3.1.2.3 Specific documents needed for review

5.1.3.1.3 After the contractor has set up a date/time for the visit, the contractor shall submit a request to the SMART Program Manager (PM) email group for a site announcement letter using the provided email template.

5.1.3.1.4 Documents and resources – Prior to the contractor visits, the contractor shall assemble all documents and resource materials needed to conduct the visit (i.e., correspondence, previously completed monitoring documents, etc.). Visit will be conducted following the studies Integrated Monitoring Plan.

5.1.4 [CLIN 0001, 1001, 2001] Subtask 1d – Conducting Site Visits

5.1.4.1 In conducting these sites visits, the contractor shall:

5.1.4.1.1 Review subject and investigator study records for compliance with GCP, VA and CSP research policy

5.1.4.1.2 Check for study protocol compliance

5.1.4.1.3 Review Essential Documents Binder (EDB)

5.1.4.1.4 Conduct Informed Consent and HIPPA review

5.1.4.1.5 Conduct participant data review

5.1.4.1.6 Verify Case Report From (CRF) data against Source documents

5.1.4.1.7 Review source documents for Adverse Events (AE)/Serious Adverse Events (SAE)

5.1.4.1.8 Review electronic medical record for unidentified SAEs

5.1.4.1.9 Review CRFs for accuracy and legibility

5.1.4.1.10 Check for CRF submission to Data Coordinating Center

5.1.4.1.11 Know and comply with VA Privacy and Data Security Policy during site visits

4.4.4.1.12 Provide CSP Director and SMART Staff Leadership immediate (when discovered) feedback of significant or serious noncompliance discoveries made during site visits

5.1.4.1.13 Provide guidance during site visits on study conduct and use of GCP tools to improve study site practices

5.1.4.1.14 Assess effectiveness of interactions between the investigator site study team and the contractor and other representatives of CSP

5.1.4.1.15 Determine follow-up actions to be taken

5.1.4.1.16 Provide relevant GCP training and re-education as needed

5.1.4.1.17 Conduct exit interview with study team to discuss site status

5.1.4.1.18 Notify the Lead CRQA and SMART of recurrent and/or serious compliance deficiencies immediately of becoming aware of such deficiencies

5.1.4.1.19 Assist during and after the visit as necessary with development and implementation of Corrective Actions and/or Preventive Actions (CAPAs) to mitigate recurrence of compliance deficiency

5.1.5 [CLIN 0001, 1001, 2001] Subtask 1e – Prepare site visit reports and summary letters

5.1.5.1 The Government sponsor/site will provide study specific templates to the monitor upon assignment of study training and visit.

5.1.5.2 Within seven business days (or current SOP requirement) of the last day on site of site visit, the contractor shall complete a site visit report, Summary for Investigator, applicable attachments (using provided templates), and supporting documents and provide these documents to the SMART PM group by posting to SMART SharePoint site or other location as directed by SMART leadership. See Section 5.4 Deliverable Schedule.

5.1.5.3 Provide all QA visit logs and scanned documents related to site visit to SMART and Study Lead Monitor for review, follow-up, and finalization. QA activities performed include:

5.1.5.3.1 Summary of findings, conclusions, and any actions taken or planned to correct any deficiencies noted during the visit

5.1.5.3.2 All documents must be submitted in the specified electronic format using the required templates. Content must be clear, detailed and accurate.by SMART staff, site staff and CSP study personnel. Content shall be grammatically correct, and content verified for accuracy.

5.1.5.3.3 Inform the SMART study lead monitor of recurrent and/or serious compliance deficiencies

5.1.5.3.4 When required and with the guidance of the SMART Lead, assist with development and implementation of Corrective Actions and/or Preventive Actions (CAPAs) in order to mitigate recurrence of compliance deficiency

5.1.5.4 The contractor shall communicate with and provide follow up with the study lead monitor to answer all questions and issues prior to visit report approval and Summary for Investigator distribution to the intended recipients within current SOP/AMP requirement.

5.1.5.5 The contractor shall upload QA documents to the SMART portal which includes reports and follow-up summary letter.

5.1.5.6 All reports and letters will be grammatically correct and sent to the SMART for review and approval in the specified electronic format. If edits, corrections and feedback are required they will be provided by the SMART Lead and will send to CRQA prior to final distribution. The CRQA's must immediately notify SMART Leadership/Chief/Lead of any serious or significant findings of noncompliance upon discovery while still onsite. Rework will be at no cost to the Government.

5.2 [CLIN 0001, 1001, 2001] Task 2 – CRQA Visits without pre and post work (INCLUDES PORTAL-TO-PORTAL TRAVEL TIME)

5.2.1 Subtask 2a – Support of another CRQA conducting CRQA visits - one to four days on site (or Virtual Equivalent)

5.2.1.1 The CRQA may support another CRQA in conducting site Monitoring visits at the request of the Lead CRQA or SMART Leadership. For example, this may include providing support to the lead monitor during a site visit, most often during a monitoring visit, or training as a new monitor on conducting site visits.

5.2.1.2 The supporting monitor is not responsible for the pre work such as scheduling visits, pre visit log reviews, developing special tools for the visit, or any of the post work such as visit summary, visit report, summary attachments or post monitoring communication between site and lead. In summary – support of another monitor - requires no pre or post work but does include travel and actions conducted at the site.

5.2.2 Subtask 2b – Support of study kickoff, annual, program meetings or training - one to four days on site (or Virtual Equivalent)

5.2.2.1 The contractor may be required to attend or present at study kickoff meetings, annual meetings or other meetings at the direction of the Lead study monitor or SMART Leadership

5.2.2.2 The contractor may be required to attend in-house (or Virtual Equivalent) training or perform Program Quality Support (PQS) tasks at the direction of the SMART Leadership.

5.3 [CLIN 0002, 1002, 2002] Task 3 – GCP PQS to the VA Cooperative Studies Program Hourly; no travel required

5.3.1 Subtask 3a – Create Study Specific site visit tools

5.3.2 Subtask 3b – Develop GCP tools for use by participating sites

5.3.3 Subtask 3c – Design data from casebooks for organizing patient files at investigative sites

5.3.4 Subtask 3d – Develop requirements, procedures and guidance for source documentation of key study data within each trial

5.3.5 Subtask 3e – Off-Site records review of key critical data in support of risk-based integrated monitoring. Does not include off-site record review related to the preparation for “CLIN 1 & 2 On-site (or virtual equivalent) Visits with Pre and Post Activities”. This subtask includes but is not limited to:

5.3.5.1 Conduct Informed Consent and HIPPA review

5.3.5.2 Review of the Electronic Health Record (HER) for eligibility and protocol/regulatory compliance

5.3.5.3 Review of the electronic date capture system (EDC), CRF completion, correction, QA procedures

5.3.5.4 Review for study endpoints or primary outcomes data

5.3.5.5 Review for safety (unanticipated adverse event reporting and serious adverse event reporting)

5.3.5.6 Determine follow-up actions to be taken

5.3.6 Subtask 3f – Study Orientation

0.

5.3.7 Subtask 3g – Completion of training required by the Department of Veterans Affairs, VA CSP and SMART 0.

5.3.8 Subtask 3h – Serves as the Sponsor’s Designated Representative (SDR)

5.3.8.1 The SDR shall finalize and approve reports prior to distribution.

5.3.8.2 The SDR shall complete the site visit portion of the SDR form.

5.3.8.3 The SDR shall submit a request to the SMART Program Manager (PM) email group for a site visit follow up letter using the provided email template.

5.3.8.4 The SDR shall review site visit response, verify actions, communicate with site staff and site monitor prior to approving response and submitting response and SDR form to close out study visit. Lead contractor will submit a request to the SMART Program Manager (PM) email group and provide documentation of completion using current business process and forms.

5.3.8.5 Once the investigator correction action response has been received from the site the Sponsor’s Designated Representative (SDR) evaluates the corrective action response for acceptability and completeness. If rework is required, the CRQA will make the appropriate revisions (at no cost to the Government) and resubmit to SMART until accurate. The SDR ensure the Site Investigator response is acceptable and complete by:

5.3.8.5.1 Reviewing and evaluating the Site Investigator’s written response

5.3.8.5.2 Discussing the findings and specified actions with site personnel and Study Leadership as needed

5.3.8.5.3 Maintaining the secure CSP Monitor file of documents and correspondence.

5.3.8.5.4 Consulting, as needed, with the appropriate CSP Coordinating Center Project Manager, QA Nurse Specialist or designee to assist site personnel in resolving issues raised in the

5.3.8.5.5 The CRQA may be asked by the SDR to follow up with the site to verify that the action items have been completed appropriately by the site. In addition, the SDR may require the CRQA follow up with the site when necessary.

5.3.8.5.6 Documents resolution and closeout of site visit

5.4 Deliverable Schedule: The contractor shall deliver the following as stated in the table below:

Site Initiation – final report, investigator summary and supporting documents

SMART PM

10 calendar days from last day of visit unless otherwise required by CSP Director SMART Monitoring Lead SMART PM email group ABQCSPSMART-PM@va.gov

SMART PM email group ABQCSPSMART-PM@va.gov

SMART SharePoint site, URL https://www.csp.va.gov/smart/SitePages/Home.aspx

Subtask 1d

Subtask 1e

SMART Monitoring Lead

SMART PM

SMART SharePoint site, URL https://www.csp.va.gov/smart/SitePages/Home.aspx

SMART PM

Subtask 2a

SMART PM

SMART PM

SMART PM

SMART PM

SMART PM

Subtask 3d

SMART PM

SMART PM

Subtask 3f

ABQCSPSMART-PM@va.gov

ABQCSPSMART-PM@va.gov

Subtask 3h

Properly completed and submitted SDR review activities of visit reports and documents – Post Visit Properly completed and submitted SDR review activities of visit reports and documents – Post Site Response Due 30 days from last date of visit or current SOP requirement.

Due as determined by Director of SMART SMART Monitoring Lead

SMART PM

ABQCSPSMART-PM@va.gov

Task 4

COR

Invoices should be submitted in VIS Within 30 days of visit.

And after all QA services are complete and all associated QA documents are submitted.

Within 30 days of visit and after SMART PM approves the invoice, the contractor will submit the final invoice as directed in the contract ABQCSPSMART-PM@va.gov

Note -All communications regarding invoicing from a subcontractor shall be directed through the primary contract holder.

5.4.1 If for any reason a deliverable cannot be delivered as scheduled, the contractor shall notify the COR three business days prior to the due date. This notice must include the reason(s) for the delay, and the impact on the overall project.

6.0 Travel: The contractor will be required to conduct off-site remote / virtual visits and to travel to conduct on-site visits.

6.1 Coordinating travel arrangements shall be the responsibility of the contractor for on-site visits.

6.2 Travel expenses will be reimbursed in accordance with Federal Travel Regulations (Chapter 300 through 304) utilizing Government rates.

6.2.1 Contractors will be reimbursed for actual travel expenses, but the contractor will use the most economical method of travel available, including non-refundable airfares, mid-range hotels and economical car rentals matching government per diem rates (found on GSA website) whenever possible. Any rates that are outside of the Government per diem rate or a level above the most economical option (for example, but not exclusive to, car rentals that are above those considered economy) will not be accepted or paid.

6.2.1.1 Reimbursable costs include airfare, car rental, hotel, taxis, and meals and incidentals (M&IE). M&IE expenses are included only at the Federal Per Diem Rate (found on GSA website).

6.2.1.2 Travel time is not reimbursable via CLIN 0003, 1003 and 2003. For on-site visits requiring travel, portal-to-portal travel time shall be included in the order as 1 block (1 EA) of the quantity for the visit.

6.2.2 To receive reimbursement, the Contractor shall submit his/her DRAFT invoices along with travel expense worksheet (which is supplied at the time of award), receipts and all other supporting documents to the SMART focal point for review/approval prior to final invoice submission. This is to ensure final invoice is correct, so time is not spent redoing the final invoice.

6.2.2.1 Documentation to support lowest cost available is required for reimbursement and shall be uploaded with the invoice for auditing purposes.

6.2.2.2 Contractor (PRIME if there are Subcontractors) will submit all required documents noted above.

6.2.3If travel dates or location are changed at the request of the program, the change fee for new date and/or location will be reimbursed however no expenses will be reimbursed for changes made for the convenience of the CRQA.

6.2.3.1 Changes for convenience (personal reasons) are the responsibility of the contractor.

6.2.3.2 Documentation supporting change in location or dates must come from CSP program officials and /or site staff and must be submitted when invoicing.

7.0 Contractor Qualifications:

7.1 The contractor, contractor’s employees, sub-contractor and individuals who will perform work under this contract must meet all the qualifications listed below and submit copies of documents requested below prior to contract/task order start to meet contractor qualifications. Any additional contractors added later, during contract performance, shall be subject to the same procedures.

7.2 SMART reserves the right to review the qualifications of and reject proposed additional staff who do not meet the qualifications.

7.3 Qualifications required:

7.3.1 Current Curriculum Vitae (CV) or detailed resume.

7.3.2 Documentation of a Bachelor’s degree (BA/BS) in a scientific or health-related field or licensure as health care provider, (e.g., RPh, RN, MD, DO, PA CNP, etc.), or advanced degree in health-related or clinical research-related field (e.g. Pharm.D., Masters, Ph.D.) OR Certified as a Clinical Research Associate (CCRA) by the Association of Clinical Research Professionals (ACRP) or by an equivalent certifying body. Acceptable documentation: copies of degree certificate, transcripts showing awarding of degree, copy of licenses, certification certificate.

7.3.3 Documentation of completed Good Clinical Practice training provided by nationally recognized training providers (e.g., Barnett International, ACRP, CITI, CFPA). Acceptable documentation: training certification certificate.

7.3.4 Documentation of Specific training or certification in monitoring of clinical research trials and documentation in human subjects protection (HSP), provided by a nationally recognized training providers, e.g., Barnett International, ACRP, CITI, CFPA, University of North Carolina, etc., OR certification as a Clinical Research Associate, (CCRA) by the Association of Clinical Research Professionals (ACRP) or by an equivalent certifying body. Clinical trial auditing training or experience is given added consideration. Acceptable documentation: training certification or certification documents OR if clinical trial monitoring training is all on-the-job (OJT) the contractor shall provide a listing of the specifics for each individual clinical trial, duration of the work on the clinical trial and frequency of monitoring visits, disease state monitored.

7.3.5 Documentation of a minimum of ten (10) years providing Good Clinical Practice (GCP) clinical trial monitoring specifically of clinical research sites. Additional consideration given to monitoring of multi-site clinical trials as well as auditing of clinical trials. Acceptable documentation: Experience should be documented in the current Curriculum Vitae or detailed resume of each names monitor in the submission.

7.3.6 Documentation of a minimum of five (5) years’ experience providing GCP monitoring (or auditing) services for federally funded research with additional consideration to delivery of these servicers to VA funded/sponsored clinical research trials. Monitoring at a VA clinical trial site for a commercial study-sponsor does not qualify as monitoring or auditing of federally funded research.

7.3.6.1 Acceptable documentation: Provide, for each of the proposed monitors, a listing of the trial sponsors (e.g. a university trial sponsor with funding by NIA, a NIH trial, a VA funded trial, etc.), number of clinical sites monitored for the trial and frequency of monitoring visits, duration of monitoring work for each clinical trial. If the monitoring experience was through a CRO (contract research organization) contracted by a university or NIH to manage the trial, please so indicate.

7.3.6.2 Provide at least three (3) references for listed experience of delivering GCP monitoring or auditing services for federally funded research. (solicitation only)

7.3.7 Experience in medical record and clinical chart review. Resume or CV must demonstrate experience, specifying the type of medical record systems (paper, electronic). For electronic health records specify commercial system experienced with and the tools used to access the electronic health record. Indicate experience with VA electron health record and tools used to access it.

7.3.8 Computer knowledge – Skilled in Microsoft Office Programs (e.g., Outlook Email, Word, PowerPoint, Excel and SharePoint), and Adobe Acrobat. Resume or CV must demonstrate experience by describing examples such as giving presentations with PowerPoint slides, documents written with Word, schedule planning with Excel, or combine files in Adobe Acrobat.

8.0 Other requirements

8.1 Identification, Parking, Smoking, and VA Regulations:

8.1.1 Contract monitors shall be issued VA identification and shall wear it in accordance with VA provided guidance while on the premises of any VA facility.

8.1.2 It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section at the specific VA facility. VA will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

8.1.3 Smoking is prohibited inside any buildings at VA facility and prohibited area may extend as far the facility perimeter.

8.1.4 Possession of weapons on VA property is prohibited.

8.1.5 Enclosed containers, including tool kits, shall be subject to search while on VA property.

8.1.6 Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

8.2 Information Security: In accordance with Appendix A, Handbook 6500.6 Checklist blocks 7, the C&A requirements do not apply to this requirement, and Security Accreditation Package is not required.

8.3 PHI/PII Protected Health Information/Personally Identifiable Information:

PHI/PII is any information about an individual maintained by an agency, including (1) any information that can be used to distinguish or trace an individual’s identity, such as name, social security number that is linked or linkable to an individual, such as medical, educational, financial, and employment information. The CRQA will have access to PHI/PII data during performance of the tasks stated in the Statement of Work. CRQA must know and comply with VA Privacy and Date Security Policy during site visits and properly protect this information.

8.4 Contracting Officer’s Representative

Will be provided at time of award

8.5 Period of Performance:

Contract total Period of Performance consists of three (3) years

8.6 Security Requirements:

All Contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Law Enforcement Training Center/SIC. The level of background security investigation will be in accordance with VA Directive 0710 dated June 4, 2010 and is available at: http://vaww.va.gov/vapubs (VA Handbook 0710, Appendix A, Tables 1 and 2). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award and are to be completed and returned to the VA Law Enforcement Training Center/SIC within 30 days for processing. Contractors will be notified by VA Law Enforcement Training Center/SIC when the BI has been completed and adjudicated. These requirements are applicable to all Contractor personnel requiring the VA computer access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed. However, the investigation must be completed / approved before any site visits are conducted. The Contractor shall be responsible for the actions of those individuals they provide to perform work for the VA. If damage arises from work performed by Contractor personnel, under the auspices of the contract, the Contractor shall be responsible for resources necessary to remedy the incident.

The investigative history for Contractor personnel working under this contract shall be maintained in the databases of either the Office of Personnel Management (OPM) or the Defense Industrial Security Clearance Organization (DISCO). Should the Contractor use a vendor other than OPM or Defense Security Service (DSS) to conduct investigations, the investigative company must be certified by OPM/DSS to conduct Contractor investigations.

The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

Each risk analysis shall address all relevant information concerning the data breach, including the following:

· Nature of the event (loss, theft, unauthorized access); Description of the event, including date of occurrence and data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code.

· Number of individuals affected or potentially affected; Names of individuals or groups affected or potentially affected.

· Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text.

· Amount of time the data has been out of VA control.

· The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons).

· Known misuses of data containing sensitive personal information, if any.

· Assessment of the potential harm to the affected individuals.

· Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

Notification, one year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports, data breach analysis, fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution, one year of identity theft insurance with $20,000.00 coverage at $0 deductible; and necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

The contractor is required to report any Information Security or privacy breach, loss of data, inappropriate access immediately to contracting officer representative for this contract (COR), relevant facility Information Security Officer relevant facility Privacy Officer - noting details of breach circumstances, necessary remediation/corrective action as required under HIPAA regulations.

Position Sensitivity: The position sensitivity impact for this effort has been designated as LOW RISK.

8.7 Background Investigation: The level of background investigation commensurate with the required level of access is NATIONAL AGENCY CHECK WITH WRITTEN INQUIRIES (NACI) (cost is approximately $230).

8.8 Government-Furnished Equipment (GFE) AND/OR Government-Furnished Information (GFI)

8.8.1 Government furnished: Laptop computer with VA approved software (such as MS Office 365) pre-installed and PIV card shall be provided by the Government for use in providing the contracted services (use of this government-furnished laptop for all work for SMART contract services is mandatory).

8.8.1.1 Maximum number of laptops to be furnished: 3

8.8.1.2 Laptop acquisition cost is estimated to be (per laptop): $1,953.85

8.8.1.3 Property is to be furnished as-is.

8.8.1.4 The contractor is responsible for all costs related to making the property available for use, such as payment of all transportation, installation or rehabilitation costs.

8.8.1.5 Rental of the GFP IAW FAR 45.3 is not authorized under this contract.

8.8.2 Contractor furnished: The contractor shall provide all equipment and supplies necessary to perform the contract requirements as set forth in the Request Quote. The contractor’s reporting requirements will necessitate literacy in Microsoft Office Programs, e.g., Word, Excel, PowerPoint, SharePoint, as well as Internet capability to send and receive faxes, electronically transmit documents, access email and correspondence, ability to communicate during travel and securely access, store and destroy sensitive documents.

8.8.3 Computer access must be maintained following VA regulations. The contractor shall maintain VA Computer access and ensure computer and program functionality prior to monitoring visit.

8.9 Place and hours of Performance

8.9.1 The Contractor will be required to perform work at different sites (hospitals and/or clinics) throughout the United States and territories, at the Contractor’s place of business and at the SMART office in Albuquerque, New Mexico.

8.9.2 Contractor will be notified by either phone or email two months in advance of site visit. Notification will include location and details of research study.

8.9.3 The Contractor must be available by phone during business hours (8:00 am to 5:00 pm/Mountain Time) Monday through Friday.

8.9.4 There may be times when the Contractor will need to be available beyond business hours in the case of special circumstance or unannounced monitoring visit. It is essential that the Contractor be able to promptly respond to the needs of the SMART, i.e., be able to report within 24 hours to the SMART Office or to the VA research facility where visit will be conducted.

8.9.5 SMART and CSP program leadership reserves the right to accompany the Contractor on site visits at reasonable times during normal business hours.

8.9.6 Federal Holidays observed are:

And any other day the United States Presidents designates as a federal holiday.

8.9.7 Training & Additional Guidance

8.9.7.1 All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

8.9.7.1.1 Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior relating to access to VA information and information systems;

8.9.7.1.2 Successfully complete the VA Privacy and Information Security and Rules of Behavior training in TMS and annually complete required security training; before being granted access to VA information and systems and annually thereafter, URL: https://www.tms.va.gov/SecureAuth35 course name and course code: VA Privacy and Information Security Awareness and Rules of Behavior VA 10176; and

8.9.7.1.3 Successfully complete the appropriate VA privacy training in TMS and annually complete required privacy training; before being granted access to VA information and systems and annually thereafter, URL https://www.tms.vagov/SecureAuth35 and course name and course code: Privacy and HIPAA Training VA 10203; and

8.9.7.1.4 Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access. Course requirement may change, and the COR or PM will inform the contractor, when applicable.

8.9.7.2 The contractor shall provide to the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

8.9.7.3 Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time the training and documents are complete.

8.10 Records Management

8.10.1 Contractor will adhere to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

8.10.2 Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

8.10.3 Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

8.10.4 Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

8.10.5 Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

8.10.6 The Government Agency owns the rights to all data/records produced as part of this contract.

8.10.7 The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8.10.8 Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

8.10.9 No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

8.10.10 Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

8.11 Invoicing

8.11.1 Prior to submitting final invoices as stated in the signed contract, the contractor shall submit preliminary draft invoice for review to the SMART PM group (ABQCSPSMART-PM@va.gov) for services rendered and expenses incurred utilizing the invoice template, travel expense, professional service worksheets, and training documents (see Attachments A-Training for Contractor and Attachment-B Invoice Worksheet). When the contractor is a subcontractor, the primary contract holder is responsible for the review, approval and submission for payment of all invoices submitted under their contract. All communications regarding invoicing from a subcontractor shall be directed through the primary contract holder.

8.11.2 Invoices should be submitted WITHIN 30 DAYS after all PQS services are complete and all associated QA documents are submitted.

8.11.3 After SMART PM approves the invoice, the contractor will submit the final invoice as directed by the contract. This prevents invoices requiring rejection and rework when formally submitted for payment.

8.12 Multi-Sites: The following cities are examples of those with VA sites or sites within 75 miles that may be used for VA Clinical Trials for ordering period 1 through ordering period 2.

These sites apply to 1 – 4-day visits with or without pre and post work.

8.13 Quality Assurance: The contractor shall detail their internal processes for working with a customer with regards to:

8.13.1 Selection, assignment and evaluation of qualified personnel.

8.13.2 Communication with a customer regarding scheduling, report transmittals, general interface with the customer, etc.

8.13.3 Quality Assurance Plan shall be provided to the Government five days after award.

8.14 Performance Monitoring:

Refer to Quality Assurance Surveillance Plan Attachment A.

9.0 Ordering

9.1 All work performed under this contract shall only be performed by the contractor via Government issued task orders award against the base contract.

Blocks shall not be ordered in partial quantities. A full block is required for each element:

Pre/Post time = 1 block Portal to Portal Travel = 1 block On-site= 1 day = 1 block

Should the need arise for more time as a result of an emergency or Government delay, the ability to add additional hours using CLIN 0002, 1002 and 2002 may be allowable based on the agreement of both parties and approved in advance (and funded in advance or approved in advance by the Contracting Officer).

9.2 Estimate:

-Pre/Post time = QTY 1 block (limited to one per visit unless approved by COR) -On-site = 1 day = QTY 1 block -Portal-to-portal travel time = QTY 1 block (limited to one per trip) 100 Visits or 475 block

The Contractor shall provide GCP QA support to the VA Cooperative Studies Program in accordance with contract specifications.

2100 hours

-Pre/Post time = QTY 1 Block(limited to one per visit unless approved by COR) -On-site = 1 day = QTY 1 Block -Portal-to-portal travel time = QTY 1Block (limited to one per trip) 100 Visits or 475 blocks

The Contractor shall provide GCP QA support to the VA Cooperative Studies Program in accordance with contract specifications.

2100 hours

-Pre/Post time = QTY 1 Block(limited to one per visit unless approved by COR) -On-site = 1 day = QTY 1 Block -Portal-to-portal travel time = QTY 1Block (limited to one per trip) 100 Visits or 475 blocks

The Contractor shall provide GCP QA support to the VA Cooperative Studies Program in accordance with contract specifications.

2100 hours

10.0 ACRONYMS:

Department of Veterans Affairs (VA)

New Mexico Veterans Affairs Health Care System (NMVAHCS)

Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSP CRPCC)

Site Monitoring, Auditing and Resource Team (SMART)

Good Clinical Practice (GCP)

Clinical Research Quality Associate (CRQA)

Health Insurance Portability and Accountability Act (HIPAA)

Human Subjects Protections (HSP)

Case Report Form (CRF)

International Conference on Harmonization (ICH)

Institutional Review Board (IRB)

Sponsor’s Designated Representative (SDR)

Defense Security Service (DSS)

Defense Industrial Security Clearance Organization (DISCO)

Office of Personnel Management (OPM)