Research and Development Service - VA Portland HCS

Pathology, Laboratory and Pharmacy Services

IMPERATIVE: If your research protocol requires ordering blood draws or imaging or tests within the medical center, you are not a clinician and your PI has delegated the task of ordering to you, you MUST request ordering keys by sending an email to <Bezawit Demise that includes: 1) copy of your protocol (pages specified re: required orders), 2) the responsible clincian's name, and 3) assurance that your Scope of Work has been approved and you've been added to the project by the appropriate oversight committee (IRB or R&DC).

REQUIRED: Studies using VA Medical Center services (e.g., pharmacy, imaging, path and lab, etc.) must establish a Research Clinic in order to avoid billing subjects for research-related costs. Please contact Bezawit Demise at VA extension 58346 to set up your study’s Research Clinic.

Pathology and Laboratory Services

When utilizing the VAPORHCS Clinical Laboratory to collect research specimens, it is imperative that a relationship with the VAPORHCS Clinical Laboratory Research Coordinator is established. Contact with the Lab Research Coordinator assures the lab knows 1) specifically how they can support your research, 2) how much it should be compensated for its valuable and essential services and also 3) to assure accurate, efficient and timely handling of your research specimens.

For all new research studies for which lab services need to be utilized in any way (phlebotomy, specimen processing, storage or testing), please contact the VAPORHCS Clinical Laboratory Research Coordinator:

Dawn Hornby
VAPORHCS
3710 SW US Veterans Hospital Rd-P5PHAR
Portland, OR 97239
503-220-8262 ext.58344
Dawn.Hornby@va.gov
Bldg 100 Rm 2C101

You will be asked to complete the VAPORHCS lab’s New Research Study Questionnaire. Please complete it, return it electronically and/or meet with Carol to discuss your study’s needs.

1. The VAPORHCS Lab Research Coordinator, in conjunction with Research Service, will determine the cost of any phlebotomy, specimen handling, etc. that is to be completed for your study.
2. ALL RESEARCH DRAWS MUST BE ORDERED VIA VISTA OR CPRS. Please discuss this with the Lab Research Coordinator, as the lab must also be able to determine which study should pay for research-related draws.
3. If you need specimens drawn by phlebotomy for specimen processing and/or pick up later, the Lab Research Coordinator will assist in the creation of a study-specific ‘draw & hold’ research order for use with your study. In the case of specimen processing, you must provide those instructions to the Lab Research Coordinator at the time of ‘draw & hold’ creation.
4. If you want your study to remain blinded or will not be using patients’ names to order tests, they MUST be ordered in the ‘Research File’ located in VISTA. Generic instructions for doing so are here: VISTA ordering instructions.
5. Lab results ordered in VISTA are not uploaded to CPRS. You must follow the generic retrieval instructions to gather your research lab results. Please work with the Lab Research Coordinator to personalize these instructions for your study.
6. If you wish to use tissue for research purposes, please click the following link for the required steps: Steps for Using Tissue for Research.

Please call or email the Lab Research Coordinator with any questions.

Pharmacy Services

It is important to the success of your research to work with VAPORHCS services at the very earliest time point in the preparation of a research study.

If - at the time of grant proposal and/ or industry-sponsored or national cooperative assessment of the VAPORHCS site – you intend to utilize the VAPORHCS Research Pharmacy for preparation, storage, dispensing and disposal of investigational drugs, it is imperative that you contact Research Pharmacy staff.

Research Pharmacy staff must ensure adequate equipment and storage space for every study and are also willing to fully and sufficiently support your study by problem solving in advance of any foreseeable concerns. Please contact the Research Pharmacy at:

3710 SW US Veterans Hospital Rd-P5PHAR
Portland, OR 97239
503-220-8262 ext.55543
VHAPOR-PHARMresearch@va.gov

1. Prior to study initiation, study coordinator and PI must meet with Research Pharmacy staff to discuss study specific requirements and dispensing process.
2. The VAPORHCS Research Pharmacy will work with Research Service to determine the cost to procure, store, dispense and – if needed – compound the drug for each study.
3. At the time of IRB submission,
   • A VA Form 10-9012 for each investigational drug in your study must be completed.
   • Each authorized provider/ prescriber must also complete a Prescription Authorization form.
4. Only authorized providers listed on VA Form 10-9012 are allowed to order investigational medication for research subjects.
5. Study coordinator is responsible for ensuring Research Pharmacy is in receipt of most recent IRB approval correspondence, which includes; updated study documents, forms and materials.

Please call or email the Research Pharmacy with any questions.

Clinical Colleagues

VA Clinical Research Alliance (VACRA)

VACRA promotes quality VA Portland Health Care System (VAPORHCS) research by aligning researchers with current VA processes. We provide research-specific education for those from disparate backgrounds on campus about how to work within the VAPORHCS system efficiently, effectively and accurately.

Meetings are scheduled as time allows. All meetings are open to clinical researchers on both sides of the bridge; Research Administrators, Research Coordinators, Principal Investigators, IRB analysts and other program staff who support research at the VA. Meeting notes are distributed via the email list.

If you would like to be included on the email distribution list, please contact Kathrynn Mosley at Kathrynn.Mosley@va.gov.

Oregon Clinical and Translational Research Institute (OCTRI)

OCTRI is a partnership between Oregon Health & Science University and the Kaiser Permanente Center for Health Research funded by the National Center for Research Resources through the Clinical and Translational Science Awards (CTSA).

Link: http://www.ohsu.edu/xd/research/centers-institutes/octri/index.cfm
OCTRI also provides many fee-based research services for investigators who do not otherwise have access to these resources (i.e.: biospecimen processing, biostatisticians, Investigational New Drug application support, etc.).

Portland VA Research Foundation (PVARF)

The mission of the PVARF is to enhance the health of veterans of all generations through medical research by facilitating research and education activities conducted at the VAPORHCS. For grant administration information, job opportunities and Society of Clinical Research Associates, Inc. (SoCRA) membership certification reimbursement, see the PVARF Web site.

OHSU Clinical Research Coordinator Network

The OHSU Clinical Research Coordinator Network aims to foster networking, professional development, and learning opportunities for clinical research coordinators at OHSU and associated institutions by acting as a platform for sharing information, ideas and best practices among coordinators and other research staff. You can send questions to or learn ways for getting involved at: askastudycoordinator@ohsu.edu.

Data

The VA has resources for researchers to mine and analyze data as well as enter data. The following links are only available from behind the VA firewall.

Veterans Health Administration (VHA) Data Portal

Central gateway to information about VHA data sources. Find more information about those sources here.

VA Informatics and Computing Infrastructure (VINCI)

The mission of VINCI is to improve the health care of Veterans by providing researchers access to integrated national data sets and tools for analysis in a secure, high-performance computing environment. The vision of VINCI is to become VA researchers' preferred data source and data-processing environment. Go to VINCI Central to learn more.

VA Research Electronic Data Capture (REDCap)

REDCap is a free, secure Web application that facilitates the collection and entry of research data. User-friendly electronic data capture (EDC) tools enable users to quickly develop surveys and databases from conception to production on the Web without additional software requirements. This tool helps researchers enter, store, and manage their project data in a systematic manner. To learn more about the benefits and limitations of REDCap, please visit REDCap Web site.

Contact Bezawit Demise or Scott Griffin for guidance about secure research data storage.

CPRS

CPRS

CPRS stands for Computerized Patient Record System. It is one of the newest VistA applications. It provides a graphic user interface that integrates numerous existing programs for the clinical user. Staff can enter, edit and electronically sign documents and orders. Its deployment at the VA medical centers enabled a work process shift from paper-based charting to computer-based charting.

Three research notes have been templated and can be used for the following participant events:

1. Consent (note title: Research  <Research - Consent>),
2. Enrollment (note title: Research  <Research - Enrollment>)
   Please Note: If consent and enrollment occur at the same time, use the comments section of the consent note to provide enrollment information.
3. Termination (note title: Research  <Research - Termination Note>)

Some studies will need to enter a progress note at the time of each additional participant visit/interaction. However, there is no required template for follow-up visits. Each study PI or Study Coordinator can create an individualized note template for study visits. Please see the IRB SOP for the policy regarding when progress notes are required.

The above research notes can be found by using the following steps:

1. Select Patient
2. Select 'Notes' from the bottom tabs
3. Select 'New Note' from the lower left hand navigation pane
4. When the pop-up appears, select 'New Visit' tab and ensure 'Research & Development-X'(or the name of the clinic specifically created for your project) is selected as the 'Visit Location'. If the visit occurred in the past (i.e., on a previous day), please also click the check box to the right indicating it is a "historical visit" and adjust the date/time of the visit to when the visit actually occurred.
   Please Note: Using this clinic is required for all Research specific visits UNLESS the study you're working on has its own clinic OR the contact/visit/encounter is considered standard of care. If you're unsure of whether or not the study you're working on has its own clinic please contact Bezawit Demise, Administrative Director/Research, at VA extension 58346. Typically, only studies that use VA Medical Center resources (i.e., Pathology, Imaging, Ophthalmology, etc.) have their own clinics established to ensure participants aren't charged for visits and to allow cost transfers from the grant back to the VA Portland Health Care System (VAPORHCS) to reimburse for services used.
5. Click on 'OK'.
6. When the 'Progress Note Properties' pop-up menu appears, type one of the three titles listed above in parentheses in the 'Progress Note Title' box.
   Please Note: There are two spaces between the word 'Research' and the less than symbol (<). The note will automatically be selected from the list and will highlight (if you've typed the name correctly, if not, the first research note template will automatically be selected and you will need to retype the title).
7. Click on 'OK'.
8. When the note appears fill in the template blanks.
   Please Note: The blanks are required fields and the template will not allow you to save it unless information is provided for each blank.
9. Click on 'OK'.
10. Select 'Action' from the top horizontal menu bar.
11. Select 'Sign Note Now' if you have completed the note and you will be signing the note.
12. Enter your electronic signature.
13. Click on 'OK'.

1. How do I get CPRS access?
2. How do I set-up a default progress note in CPRS?
3. What progress note do I use for re-consents?
4. How do I enter a non-veteran into CPRS?
5. Is there a CPRS help document I can refer to?
6. What is the CPRS termination note used for?
7. How do I add a CPRS research flag?
8. Is there a general CPRS Research Clinic I can use?

Q: How do I get CPRS access?

A: If you will need access to CPRS and VISTA for your job duties, you must complete TMS Module VA 35795 CPRS Tab by Tab before complete access is issued. Once the course is completed the employee must download the certificate of completion and email it to VHAPOR-CPRSHelp@va.gov requesting access to CPRS and VISTA.

Q: How do I set-up a default progress note in CPRS?

A: Use the following directions to create a default progress note in CPRS:

1. Go to the CPRS Tool Bar
2. At the bottom of the Tool Bar go to Personal Preferences
3. On the Options page select the NOTES tab
4. Click on the DOCUMENT TITLES button
5. In the Document Titles windows select your note title(s)
6. Click on the ADD button
7. If more than one title select the title to default and use the SET AS DEFAULT button

Q: What progress note do I use for re-consents?

A: The consent note can be used every time a participant is consented, this includes the initial consent, subsequent consents for different phases and/or any re-consents completed.

Q: How do I enter a non-veteran into CPRS?

A: For information please contact the Enrollment Department at VA extension 55155.

Q: Is there a CPRS help document I can refer to?

A: There is a 500-slide help document accessible within the CPRS Help Menu called: Local CPRS Instructions.

Q: When do I use the CPRS termination note?

A: This note is no longer required, but you can use the CPRS termination note when the participant is no longer receiving active treatment, follow-up has been completed and you no longer need access to the participant's record.

Q: How do I add a CPRS research flag?

A: If the VAPORHCS IRB has told your study team they need a CPRS research flag, follow the instructions in the 'Research Flags' document found on the HRPP Web page of this site.

Q: Is there a general CPRS Research Clinic I can use?

A: Yes, Research and Development Service has created a general Research Clinic called 'RESEARCH & DEVELOPMENT-X' that you can use for progress notes.

Logistics: How do I conduct research at the VA?

• Does my project need to be reviewed by the Institutional Review Board (what is the difference between Quality Improvement, Quality Assurance and Research)?
  Email:PVAMC-IRB@va.gov

• Who are the IRB contacts?
  VAPORHCS IRB: Kathrynn Mosley, VA extension 52383
  Affiliate (OHSU) IRB3: Kasey Jakien, VA extension 53077
  Affiliate (OHSU) IRB3: Alissa Hooper, VA extension 53750

• What other Principal Investigator (PI) resources may be needed?
  The R&D office provides a regularly-updated PI resource page with helpful links for additional research-related services.

• What is the process for setting up WOCs?
  Please see the WOC Appointment Requirements Checklist for more information.

• When should I expect the WOC process to be complete?
  This process takes on average 35 business days to complete, it is important to start the WOC process as soon as possible.

• Who is my point of contact for the WOC process?
  POC: Andrea Huang, VA extension 55125

• Who is the contact for Scopes of Work and Credentialing?
  POC: Andrea Huang, VA extension 55125

• Who is the contact for Personnel Changes?
  Please email: PVAMC-IRB@va.gov

• What is VistA and how do I use it?
  VISTA stands for Veterans Health Information Systems and Technology Architecture. It is a national database composed of several different applications which encompass infrastructure, administrative, financial and clinical functions.

• How do we purchase office supplies for our research program at the VA?
  Information for purchasing office supplies can be found on the PI Resources page under Purchasing: Purchase Cards, IPAs, IT Purchases.
  
  
• How do I get a new computer?
  New computers can be requested by submitting a request through yourIT, application is located on the desktop of all VA computers.
  
  
• How do I submit a Work Order Request?
  Please fill out the work order request with all the appropriate information and then email the completed form to Research Support Staff. See instructions here.
  
  
• Where do I get a lab coat?
  Location: The uniform room is located in building 100, P2 level. VA extension 55800.
  
  
• Who do I contact to reimburse my research subjects from my VA project budget?
  You may contact the VA Research Accounting and Finance staff for more information. Subject reimbursement instructions can be found at the Research & Development - Finance and Purchasing Web page.
  
  
• Who do I contact about study budgets?
  POC: Travis Peake, VA extension 57895

• How do I archive documents for closed studies?
  Please contact Robb White at VA extension 56619.
  
  
• Now that the Research Office has gone electronic, what is the requirement to keep hard copies versus electronic copies of documents?
  Research now has a records control schedule, as such research records no longer need to be retained indefinitely. In addition, we are now media neutral, meaning the original version of the document no longer needs to be retained as long as you have a copy. For example, if you have a hard copy document that you scan in and save to a network folder, you can destroy the hard copy. Please contact the Research Administration Office for assistance with archiving or with records retention questions.
  
  
• How can I advertise a clinical trial at the VAPORHCS?
  Posting VA IRB approved advertisements and fliers.
  POC: Raquel Valle-Riestra at VA extension 56601.

• How do I request VA remote network access?
  From a VA networked computer, use this link to access the Remote Access Management Platform:(RAMP)
  
  
• How do I request a Research Clinic?
  POC: Bezawit Demise at extension 58346
  
  
• How do I get access to VA network drives?
  POC: Robb White at VA extension 56619.
  
  
• How do I get help from the Office of Information and Technology (OI&T)?
  For any VAPORHCS computer or phone issue or to request a pager, contact the Region 1 Help Desk by submitting an IT work request or call VA extension 55909.
  
  You can also access yourIT from a VA computer using the desktop icon.

• How do I learn more about the VAPORHCS's Information System Security Officer's (ISSOs) and what they oversee?
  Go to the VAPORHCS ISSO website for FAQs, guidance and contact information.
  
  
• How can I send Protected Health Information (PHI), Individually Identifiable Information (III) or VA Sensitive Information (VASI) securely?(only available from behind the VA firewall)
  
  1. Via MS Outlook (NO!)
  2. Via PKI Encryption in MS Outlook (YES!)
  3. Via VistA (YES!)
  4. Via RMS in MS Outlook (YES!)
  5. Via MS Teams (YES!)
  6. OHSU's secure mail option is not compliant with VA requirements for sending PHI, III or VASI. Questions regarding the transfer of PHI, III or VASI can be directed to the Information Security Officers by email at VHAPOR-ISO@va.gov.

• What is the difference between the Privacy Officer (PO) and the Information System Security Officer (ISSO)?
  The PO tells you what Protected Health Information (PHI), Individually Identifiable Information (III), and VA Sensitive Information (VASI) is and the ISSO tells you how to protect PHI, III and VASI.
  
  
• What else is the PO and the ISSO responsible for?
  The PO is responsible for pre- and post-review of all initial and continuing reviews of human subjects protocols as well as reviewing modifications and amendments that affect the security of PHI, III and VASI that are submitted to the IRB. The PO also reviews and approves all HIPAA authorizations, reviews accounting of disclosures tracking spreadsheets, audits the use of VA Form 10-0483 "Acknowledgement of Receipt of Notice of Privacy Practices", account creation for initial enrollment of all Veteran and non-Veteran research participants, monitoring Privacy and HIPAA training compliance, reviewing and signing Data Use Agreements, and reviewing and approving all business associate agreements with third party contractors.

• Are there private clinic or exam room locations at the VAPORHCS that can be used for research purposes?
  Yes! See Clinic Profiles; Specialty Clinics and Primary Care Physician look-up.

• I know where to find most government funding opportunities, but are there other listings I’ve missed?
  Information on funding opportunities can be found on the Research web site by clicking on Grant Submission (in the left hand navigation pane) or by going to the VHA ORD Funding Web site.
  
  For information on other funding opportunities, OHSU provides two places to look for funding opportunities, Research News and SciVal, which is only accessible with a username and password.
  
  
• How do I find out about upcoming grant submission deadlines?
  Information on upcoming grant submission deadlines can be found on the Grant Submission of the R&D Web site.
  • POC: Danielle Beaudry for Merit Reviews and SPiRE grants.
  • POC: Robb White for Career Development and Career Scientist grants.

Helpful Handbooks:
All Directives and Handbooks can be found at: VHA Publications

General Research Information

• Research and Development Program Overview (VA Directive 1200)

Human Subjects Protection

• Research Compliance Reporting Requirements (1058.01)

• Requirements for the Protection of Human Subjects in Research (1200.05)

• Protection of Human Subjects, 38 CFR Part 16

Privacy and Information Security

• VHA Privacy Program (VHA Directive 1605)

• Privacy and Release of Information (VHA Handbook 1605.1)

• Minimum Necessary Standard for Protected Health Information (VHA Handbook 1605.02)

• Privacy Compliance Assurance Program and Privacy Compliance Monitoring (VHA Handbook 1605.03)

• Information Security Program (VA Directive 6500)

Helpful VHA Links

Office of Research and Development homepage (VA Web Site)
Office of Research and Development web site has links to handbooks, training announcements, funding opportunities, research program information, etc.

Program for Research Integrity Development & Education Policy and Guidance homepage (VA Web Site)
The mission of VA's Program for Research Integrity Development & Education (PRIDE) is to protect participants in VA human research. PRIDE is responsible for: all policy development and guidance for human research protection in the VA; all training and education in human research protection throughout the VA; ensuring all VA facilities with Federalwide Assurances attain Full AAHRPP Accreditation; and creating and implementing the VA Central IRB. PRIDE's Vision is to make VA human research as safe as possible.

Office of Research Oversight (ORO) homepage (VA Web Site)
ORO serves as the primary VHA office in advising the Under Secretary for Health and exercising oversight concerning all matters of research compliance and assurance, including human subject protections, laboratory animal welfare, research safety, research laboratory security, research information security, research misconduct, debarment for research impropriety, and other matters that the Under Secretary for Health may assign. Auditing tools, regulations, policies and guidance on compliance are available on this web site.