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Research & Development - Clinical Research Resource Page

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Good Clinical Practice Resources


The Cooperative Studies Program offers an excellent tutorial for Good Clinical Practice (GCP). In addition, regulatory documents are provided courtesy of Cooperative Studies Program Site Monitoring Auditing & Review Team (SMART). These documents can be very helpful in organizing investigator-initiated studies and maintaining compliance. Research and Development Service of the Portland VA Medical Center is not responsible for the information within the documents. Information contained in the documents should be used as a guide only. It is the Principal Investigator's responsibilities to ensure any documents developed using these tools comply with current VA policies and regulations.

This is the inTRAnet website address and is not available through the internet unless on a VA computer: https://vaww.csp.research.med.va.gov/gcp/gcptools.cfm (VA inTRAnet web site)

Additionally, the following link will take you to the PI Resources page where good clinical practice information is provided. The information provided should be used as a guide only and it is the responsibility of the end user to ensure it complies with all current regulations and policies.

 

R&D Site Map

Training and Education

Required Training Links for Conducting VA Research
Portland VA Research Annual Safety Trainings
CITI Human Training

VA Talent Management System. This web site is for paid and non-paid employees to complete their VA mandated training requirements. For questions on access please contact Richard Lightfoot at extension 57813 or by email at richard.lightfoot@va.gov.

Educational Opportunities
OCTRI Coordinator training

R&D Site Map

Laboratory and Pharmacy Services

Quick links for this tab:
Laboratory Service
Pharmacy Service




IMPERATIVE: If your research protocol requires ordering blood draws or imaging or tests within the medical center and you are not a clinician, you MUST: 1) send a copy of your protocol (pages specified), the responsible clinician's name and assurance that your Scope of Work has been approved by the VA IRB, and 2) request ordering keys from Andy Covington, Chief of Clinical Applications at Zandrew.Covington@va.gov.



REQUIRED: Studies using VA Medical Center services (i.e.: pharmacy, imaging, path and lab, etc.) a Research Clinic MUST be established in order to avoid billing subjects for research-related costs. Please contact Sharon Jacky at extension 58346 or by email at sharon.jacky@va.gov to set up your study’s Research Clinic.




Laboratory Services

When utilizing the PVAMC Clinical Laboratory to collect research specimens, it is imperative that a relationship with the PVAMC 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 PVAMC Clinical Laboratory Research Coordinator:

Patty Koenig, MT/SH(ASCP)
Portland VA Medical Center
3710 SW US Veterans Hospital Rd-P5PATH
Portland, OR 97239
503-220-8262 ext.58344
Patty.Koenig@va.gov
Bldg 100 Rm 2C101

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

  1. The PVAMC 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.

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

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Pharmacy Services

It is important to the success of your research to work with PVAMC 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 Portland VA site – you intend to utilize the PVAMC 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-P5PATH
Portland, OR 97239
503-220-8262 ext.55543
VHAPOR-ResearchPharmacy@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 PVAMC 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.

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R&D Site Map

Clinical Colleagues

VA Clinical Research Alliance (VACRA)

VACRA promotes quality PVAMC 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 Portland VA system efficiently, effectively and accurately.

Meetings are held the 2nd Tuesday of every month from noon to 1pm in Bldg 101, Room 433. 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 Paige Farris listed below.

Printable VACRA information (41KB, PDF)

Colleagues:

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Nursing Research at the VA

In addition to carrying out independent, funded research, the Nursing Research Department provides a forum supporting an environment that promotes professional nursing practice grounded in research and theory, and serves as a resource in the application of research into the delivery of evidence based nursing care through the Nursing Research Committee.

(These are INTRAnet web sites and are not available through the inTERnet unless on a VA computer)
Link: http://moss.portland.med.va.gov/NursingResearch/default.aspx
Link: http://moss.portland.med.va.gov/Nursing/NRC/default.aspx

Colleagues:

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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.).

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Clinical Research Administrators Meeting at OHSU

Quarterly meetings are an announced to the VA via the VACRA email distribution list.
Colleagues:

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R&D Site Map

VA Medical Data



Definitions
VISTA
VISTA stands for Veterans Health Information Systems and Technology Architecture. It is a national database composed of 99 applications which encompass infrastructure, administrative, financial and clinical functions.
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.
Required Notes

Three required notes have been templated and must 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>)
A progress note is also required 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.

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' 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 Sharon Jacky, Administrative Officer/Research, at extension 58346 or by email at sharon.jacky@va.gov. 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 Medical Center 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'.

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To request study specific progress notes be created, please contact Sharon Jacky, Administrative Officer/Research, at extension 58346 or by email at sharon.jacky@va.gov.

Specific Research CPRS training will be offered quarterly at the VACRA meetings and will be conducted by a Clinical Applications Coordinator.

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Frequently Asked Questions

  1. How do you get CPRS access?
  2. How do you set-up a default progress note in CPRS?
  3. What progress note do I use for re-consents?
  4. How do you 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?



Q: How do I get CPRS access?

A: To register, you will need to log on to a VA computer, navigate to the Portland VA Medical Center InTRAnet homepage, go to the right-hand side navigation bar and click on the CPRS link located under the green colored "Clinical Resources" section. The link will not work from a non-VA computer unless you are logged on to the VA network through VPN or Citrix.



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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


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

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



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

A: There are two ways to submit information to the Enrollment Department in order to create a record for a non-Veteran patient. The full name, DOB, SSN, address and phone of the subject is always required, however the information can be sent either by e-mail through VISTA "G.Enrollment" or by fax to (503) 402-2909. Once the information has been submitted to Enrollment, please allow a few days for entry. For additional information please contact the Enrollment Department at extension 55155.


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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.


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Q: When do I use the CPRS termination note?

A: You use the CPRS termination note when the participant is no longer receiving active treatment and follow-up has been completed.


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R&D Site Map

Logistics: How do I get things in line so we can do 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)?
POC: Mica Werner, extension 54481
Who are the IRB contacts?
IRB #1 Lead: Kathrynn Mosley, extension 52383;
IRB #1 Back-Up: Alex Mitchell, extension 54503
Who is the contact for Scopes of Work, Credentialing and Personnel Changes?
POC: Richard Lightfoot, extension 57813
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 1-2 months 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: Kenneth Fouse, extension 57040
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?
POC: Sharon Jacky, extension 58346
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 Submitting a Grant (in the left hand navigation pane) and then clicking on VA Grant Funding Opportunities.

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 archive documents for closed studies?
Please contact Kenneth Fouse at extension 57040.
Now that the Research Office has gone electronic, what is the requirement to keep hard copies versus electronic copies of documents?
The requirement to retain research documents indefinitely requires individuals to maintain the primary source document indefinitely. Translation, any document that is generated for a grant application/research study, submitted on behalf of the research study, etc. must be retained indefinitely until otherwise notified. The only exception to this rule is working or draft documents that are later replaced by final versions. For example, if you received the final version of a document electronically, you must retain that document electronically (a hard copy is not necessary) indefinitely. If you received the final version of a document in hard copy, even if you scan in the document, you must still retain the hard copy document indefinitely. Please review ORD's Guidance on Identifying and Managing Records for more detailed information.
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R&D Site Map

Helpful Handbooks



General Research Information

Research and Development Program Overview (VA Directive 1200)
Responsible Conduct of Research at the Portland VA Medical Center, Medical Center Memorandum 151-01

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 1605.2)
Privacy Compliance Assurance Program and Privacy Compliance Monitoring (VHA Handbook 1605.03)
Information Security Program (VA Directive 6500)

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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.

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R&D Site Map