Clinical Research

Number of full time/part time research staff – The Truman VA Research Department has approximately 40 VA staff including pre-clinical investigators and administrative staff, with an additional 200 professionals who are classified as WOCs. This means that, while they work on VA Research projects directly or in an administrative capacity for VA Research, their salary may come from other sources such as Post Doctoral Fellowships through the University of Missouri or they may work directly for the Missouri Foundation for Veterans’ Medical Research. These professionals must also meet all the rigorous requirements and standards applied to staff paid directly by the Truman VA.

In addition to pre-clinical research, Truman VA has approximately 40 human subject clinical studies on-going at any one time, with about 6 of these being clinical trials. PI for this profile is Principal Investigator for the Alliance for Clinical Trials in Oncology (ACTO) formerly CALGB, a nationwide study.

Clinical Research Associate: Brenda McCoy, Certified Clinical Research Professional-CCRP; 14 years experience in the field; Society of Clinical Research Associates (SOCRA)

The CRA will assist in coordinating grant and start-up procedures; prepare annual submission of protocol review and amendments to IRB and VA R&D; screen potential candidates; recruit, register and randomize patients; patient education; informed consents; collect, record, manage research data; initiate health forms, surveys, questionnaires and assessments; initiate clinic notes in Computerized Patient Record System (CPRS); chart reviews, patient record searches, appointments, mailings; insure closing procedures of study are completed; order, maintain supplies for studies; lab processing and shipment

Research RN Clinician/Oncology: E. Troy Twyman, R.N., CRA, Chemotherapy Certified, BLS Certified; Therapeutic areas: Oncology, Hematology, Pulmonology, Otolaryngology, Gastroenterology, Breast, Melanoma, and Prostate; 14 years experience with Oncology

Pharmacist on Oncology Clinic Floor: Janelle L. Maland, Pharm D, BCOP, Clinical Pharmacist, Oncology Team, IV and oral Chemotherapy

Study Drug will be shipped to:

Danielle Field, Pharm.D. BCPS, Clinical Research Pharmacist
Harry S Truman Memorial Veterans’ Hospital
800 Hospital Drive
Columbia Missouri 65201
Office: 573-814-6000 Ext 53787

Protocol materials shipped to: Principal Investigator for each study or their designee will receive all lab kits, binders, and regulatory documents. Such documents will be stored in the CRA’s locked office in locked file cabinets or in the PI’s locked cabinets in his office.

Electronic or paper medical records: Truman VA utilizes Electronic Medical Records. The system is a validated part of the federal data base with certified access and one-source patient records. Truman VA has an on-site Privacy Officer and an on-site Information Security Officer. The electronic system is validated and there are no VA/GFE laptops (Government Furnished Equipment (GFE). Only de-identified patient information may be transmitted via wireless.

Experience using electronic CRFs: Truman VA staff have experience utilizing Electronic Case Record Forms (eCRF’s). The VA system does not allow identifiable electronic case record forms transmission.

Internet access: Truman VA has both wired and wireless internet for the Investigator and staff. Clinical areas which dispense medications have wireless access. Only VA-owned and issued devices may be connected to the VA network, both wired and wireless. All patient information relayed via wireless is encrypted. The use of de-identified eCRFs is allowable.

Clinic: Truman VA has 3 oncology exam rooms; one infusion area with eight monitored chemotherapy chairs; 3 offices, two of which are also exam rooms, with locked records storage; a separate secure locked, temperature-controlled chemotherapy mixing room with hood and locked study-designated storage for study drugs.

Instruments and Equipment Available

The Central Lab is CLIA and CAP accredited and is equipped with centrifuges, refrigerators, freezers (non-frost-free, -20C, -80C) with alarms. Truman VA facilities have on-site back-up power generators. We have dry ice delivered weekly to the research department for shipping samples. Shipping can be arranged via UPS or through sponsor’s designated carrier.

IATA code – COU; ICAO code – KCOU

Limited access: Our Pharmacy has electronic badge access for Pharmacy employees only. We have a separate storage cabinet in secure area for Research/Investigational Use for Pharmacy. Drugs will also be stored in locked room within locked cabinet on Oncology Clinic Floor.

Ambient temperature monitoring: We have requested that Ambient Room Temperature monitoring equipment be installed in the Inpatient and Outpatient Pharmacy areas through our hospital’s TempTrack system

Refrigerator: Dedicated, locked Research/Investigational refrigerator within infusion area that is computer monitored, on TempTrack monitoring system and password-protected access.

Freezer: We do not currently have a dedicated locked Research/Investigational freezer within locked Pharmacy space, but this equipment will be purchased.

Temperature Logs: Dedicated refrigerator in Oncology infusion area has TempTrack and we will be able to install TempTrack monitoring systems on any future cooling/freezing devices. TempTrack logs are continually monitored and archived electronically by the hospital. Daily average temperatures in each area or cooling device are readily retrievable and are also noted on a form on the outside of the equipment.

Back-up power: Our hospital provides emergency backup power to the hospital, all clinics, the main Pharmacy, all labs and radiology

Separation of investigational & commercial drug: Currently the mechanism we use for room-temperature Investigational Drug storage is a pair of lockable file cabinets residing in the main Inpatient Pharmacy area. Keys to these file cabinets are kept in the Narcotics Vault Pyxis. Previous small-scale storage of refrigerated Investigational Drugs has been in our small narcotics vault refrigerator. Oncology clinic Hood room also has separate shelving for non-refrigerated study drug storage.

Will used drug be kept until monitor performs accountability: We currently do not have an adequate locked storage room or space within Pharmacy to store all used/partially-used/empty vials/bags/unit doses/bottles for accountability, unless accountability/destruction by sponsor monitors is done on a very regular (at least monthly) basis, or the sponsor allows regular mail-back of said items

Destruction (on site or return to Sponsor): (see above point) We can also dispose of sharps, and bio-hazards through the hospitals regular sharps boxes, bio-hazard bags and canisters.

• CT- GE VTC CT scanner (64 slice)
• Angiography – Siemens Axiom Artis dTA angiography unit
• MRI – Philips Intera 1.5T MRI (contract services), unit is full time on site; new purchase on-site unit Dec 2012 planned
• PET – GE Discovery ST 8 slice PET/CT (contract services), unit is here weekly
• Gamma – Philips Forte Epic HP
• Cameras – Siemens Symbia T, SPECT/CT
• (Nuclear Medicine) – Siemens Symbia S
• EKG – calibrated GE 5000 signal averaging, calibrated by VA bio-engineering
• DEXA scanner
• Spiral CT’s are preformed in X-ray Department along with CXR and DEXA scans.
• Scales are pounds and metric, both standing and wheelchair Health-o-meter
• Blood Pressure devices – Casmed 740 automatic works with VistA/CPRS hospital information systems, enabling integration from the bedside vital signs; also manual devices

Truman VA has satellite Community-Based Outpatient Clinic sites across Missouri in the following:

• Waynesville (Fort Leonard Wood)
• Sedalia
• Kirksville
• Mexico
• Jefferson City
• Saint James
• Lake of the Ozarks

Study recruitment may take place in these satellite sites. Subjects may be referred to the primary location, Truman VA in Columbia, for treatments depending upon the protocol. PI will see any referred subjects at the primary VA location in Columbia.

Contact for budgets, CDA’s, Cooperative Research and Development Agreements and other contracts:

Sharon Feltman, MPA, LPN, Executive Director
Missouri Foundation for Veterans’ Medical Research
800 Hospital Drive, PO Box 605, Columbia, Missouri 65205

Phone: 573-814-6555 | Fax: 573-814-6551 | Email: Sharon.Feltman@va.gov

All contracts must be approved by the VHA Regional Counsel prior to being signed by the Foundation Executive Director and the Hospital Director. Sponsors having a Master Cooperative Research and Development Agreement with VHA will find their contracting process expedited. Turn-around time for contracts will be between 1 and 3 months and is dependent upon budget negotiations and finalization of protocol. The final contract will not be signed without the budget and protocol attached.

Payments:
Missouri Foundation for Veterans’ Medical Research
PO Box 605, Columbia, Missouri 65205

*We also have an electronic payment mechanism.

Type and Number of Patients: Adult and Geriatric – average age 62 years, 36,000 unique patients. 2,000 of these are female.

Oncology patients seen at Truman VA between 8/11/10 and 8/11/11 presented with the following incidence:

• Breast – 171
• GI – 1548
• GU – 7000
• Leukemia – 445
• Lymphoma – 603
• Myeloma – 152
• Neurologic – 59
• Respiratory – 1050

Electronic patient database – YES

Recruitment techniques include: patient database, medical records, provider referrals, advertising through on-site flyers and clinic contacts, targeted mailings

Non-English Consent Forms: It is the policy of VA Heartland Network to provide access to persons who are eligible for programs or services of VISN 15 facilities to which they are entitled. Persons who, as a result of national origin, are Limited in their English Proficiency (LEP), will be provided language assistance at no cost to them. Depending upon the needs and urgency of the situation, the following options are available:

On-site interpreting services: Providing as much advance notice as possible, supervisors will contact the LEP Coordinator to arrange scheduling of these services.

Over the phone interpreting services: An account has been established with an on-demand telephonic interpreter service that provides support by matching limited English proficiency individuals with the best linguist for his/her needs at any hour of the day, seven days a week.

Written translation services (electronic, written, multimedia materials, training and educational materials): Providing as much advance notice as possible, supervisors will contact the LEP Coordinator to arrange scheduling of these services.

Prior experience meeting study enrollment goals: As a site for VA CSP (Cooperative Studies) trials including several in the last five years, Truman VA has a history of meeting enrollment goals and has no sanctions for recruitment.

Total turn-around time for VA R&D committee and IRB approvals will be between 2 and 4 months. For sponsors with CIRB approvals, Master CRADA agreements and active exact protocol within the VA system, process may be expedited.

Local IRB: IRB of record is the University of Missouri Health Sciences IRB’s. The MU Health Sciences Institutional Review Board is duly constituted according to the requirements of the Health and Human Services and Food and Drug Administration regulations. Operations are conducted within federal regulations.

The IRB conflict: of-interest policy does not allow investigators who are IRB members to vote on protocols in which they are involved. The two boards each meet once a month. The VA Central IRB, also an IRB of record, is used for multi-site studies funded by the VA and meets once a month. The Missouri Foundation for Veterans’ Medical Research is a signatory on the VA/MU IRB Memorandum of Understanding and also has a separate Memorandum of Understanding with the University of Missouri Health Sciences IRB’s.

A contract is required before IRB submission/approval

Central IRB: If protocol has CIRB approval, local approval may take between 2 – 4 weeks, depending upon scheduled meetings.

Other committees that, depending upon the nature of the protocol, require study review/approval may include:

• VA Research and Development Committee meets once monthly
• Radiation Safety
• Sub-Committee for Research Safety
• Sub-Committee for Animal Safety if animals are involved
• IBC – Bio-Hazard Safety (Joint Committee with University of Missouri)