Good Clinical Practice Resources
The Cooperative Studies Program (CSP) 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. You must be on the VA intranet to access this useful toolkit. See CSP SMART Web site.
Research and Development Service of the VA Portland Health Care System (VAPORHCS) 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 responsibility to ensure any documents developed using these tools comply with current VA policies and regulations.
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Research-specific Training Required at the VA Portland Health Care System (VAPORHCS)
Click the following link to find research-specific training requirements:
VAPORHCS Research Required Trainings
VA Talent Management System. This web site is for paid and non-paid employees to complete their VA mandated training requirements. For questions about access to TMS please contact Richard Lightfoot, VA extension 57813. Currently, modules required for R&D are:
- Privacy and HIPAA Training
- VA Privacy and Information Security Awareness and Rules of Behavior
Computer Classes (includes Microsoft Applications, non-clinical and basic software CPRS Training):
Computerized Patient Record System (CPRS) Tools:
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Laboratory and Pharmacy Services
Quick links for this tab:Laboratory ServicePharmacy ServiceFor additional resources, explore the VA Portland Health Care System (VAPORHCS) Intranet homepage
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 from Steven DeNoya, Chief, Health Informatics by: 1) sending a copy of your protocol (pages specified re: required orders), 2) the responsible clinician's name and 3) assurance that your Scope of Work has been approved by the VA IRB to Steven.DeNoya@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 VA extension 58346 or by email at to set up your study’s Research Clinic.
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:
Patty Koenig, MT/SH(ASCP)
3710 SW US Veterans Hospital Rd-P5PATH
Portland, OR 97239
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 Patty to discuss your study’s needs.
- 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.
- 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.
- 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.
- 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.
- 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.
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-P5PATH
Portland, OR 97239
- Prior to study initiation, study coordinator and PI must meet with Research Pharmacy staff to discuss study specific requirements and dispensing process.
- 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.
- 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.
- Only authorized providers listed on VA Form 10-9012 are allowed to order investigational medication for research subjects.
- 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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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 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)
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).
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: email@example.com.
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The VA has resources for researchers to mine and analyze data as well as enter data.
Veterans Health Administration (VHA) Data Portal
is the 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
Contact Sharon Jacky or Phillip Cauthers for guidance about secure research data storage.
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Required Research CPRS Progress Notes
- 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. For additional CPRS information, see CPRS Tips & Tricks.
Three required notes have been templated and must be used for the following participant events (except for IRB approved retrospective chart reviews):
- Consent (note title: Research <Research - Consent>),
- 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.
- 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:
- Select Patient
- Select 'Notes' from the bottom tabs
- Select 'New Note' from the lower left hand navigation pane
- 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 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.
- Click on 'OK'.
- 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).
- Click on 'OK'.
- 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.
- Click on 'OK'.
- Select 'Action' from the top horizontal menu bar.
- Select 'Sign Note Now' if you have completed the note and you will be signing the note.
- Enter your electronic signature.
- Click on 'OK'.
To request study specific progress notes be created, please contact Sharon Jacky, Administrative Officer/Research, at VA extension 58346.
Specific Research CPRS training will be offered quarterly at the VACRA meetings and will be conducted by a Clinical Applications Coordinator.
Frequently Asked Questions
- How do you get CPRS access?
- How do you set-up a default progress note in CPRS?
- What progress note do I use for re-consents?
- How do you enter a non-veteran into CPRS?
- Is there a CPRS help document I can refer to?
- What is the CPRS termination note used for?
- How do I add a CPRS research flag?
Q: How do I get CPRS access?
A: To register, you will need to log on to a VA computer, navigate to the VAPORHCS 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.
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:
- Go to the CPRS Tool Bar
- At the bottom of the Tool Bar go to Personal Preferences
- On the Options page select the NOTES tab
- Click on the DOCUMENT TITLES button
- In the Document Titles windows select your note title(s)
- Click on the ADD button
- 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 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.
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 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: You use the CPRS termination note when the participant is no longer receiving active treatment and follow-up has been completed.
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.
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Logistics: How do I conduct research at the VA?
INSTITUTIONAL REVIEW BOARD:
WITHOUT COMPENSATION (WOC) EMPLOYEES (i.e., OHSU, PVARF, non-pay, etc):
- 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, VA extension 54481
- Who are the IRB contacts?
IRB #1 Lead: Kathrynn Mosley, VA extension 52383;
IRB #1 Back-Up: Alex Mitchell, VA extension 54503
- 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.
CREDENTIALING IN SUPPORT OF WOCs:
VETERANS HEALTH INFORMATION SYSTEMS AND TECHNOLOGY ARCHITECTURE (VistA):
- 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 4-6 weeks 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, VA extension 57040
OFFICE SUPPLIES, EQUIPMENT & BUDGETS:
- 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. See the VistA Quick Links below for additional information.
- 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, VA extension 58346
- 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 Heather Parman. See instructions here.
- Where do I get a lab coat?
Location: The uniform room is located in building 100, P2 level. VA extension 55800.
- How do I order business cards?
POC: Ira Knapp, VA extension 56623
- 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: John Zoller, VA extension 57895
RESEARCH TECHNICAL SUPPORT
- How do I archive documents for closed studies?
Please contact Kenneth Fouse at VA 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.
- How can I advertise a clinical trial at the VAPORHCS?
- Monthly Research Outreach Event
POC: Richard Lightfoot at VA extension 57813.
- Posting VA IRB approved advertisements and fliers may require going to the Education Office (building 101, room 215) for approval.
POC: Heather Parman at VA extension 56619.
INFORMATION SECURITY CONSIDERATIONS:
- Who is my TAC (Technical Applications Coordinator)?
POC: Sharon Jacky at VA extension 58346.
Provides troubleshooting and software assistance; creates and assigns permissions to research network folders; establishes research clinics within CPRS; approves VPN and/or CITRIX access; and approves PIV Only Authentication exemption requests.
- How do I learn more about every day computer topics within the VAPORHCS?
On the VAPORHCS InTRAnet, please check out the Education Service offerings and helpful information.
- 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.
Start at the Self-Help Center on the VAPORHCS OI&T SharePoint for basic how-tos (including how to set-up a VA network printer).
PRIVACY AND HIPAA CONSIDERATIONS:
- How do I learn more about the VAPORHCS's Information Security Officer's (ISOs) and what they oversee?
Go to the VAPORHCS ISO 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?
Via Lync (YES!), Via MS Outlook (NO!), Via PKI Encryption Via MS Outlook (YES!), Via VistA (YES!), Via RMS in MS Outlook (YES!)
CLINIC INFORMATION (i.e.: private exam rooms for research visits):
- What is the difference between the Privacy Officer (PO) and the Information Security Officer (ISO)?
The PO tells you what Protected Health Information (PHI), Individually Identifiable Information (III), and VA Sensitive Information (VASI) is and the ISO tells you how to protect PHI, III and VASI.
- What else is the PO 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.
- Who do I contact for Clinic Space to meet with participants?
The VA R&D Administration Office contacts the Nurse Manager to help find rooms that can be used for research visits. There is a form to fill out to request that R&D will submit on behalf of a study. POC: Heather Parman at VA extension 56619.
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- 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.
- The page's Grant Management tab contains local Letter of Intent (LOI) deadlines
- The page's grant specific tabs contain calendar links showing the most recent local deadlines for grant submission
- The Calendar of submission due dates for VACO (linked above the tabs on the page) can be used alongside the most recent local deadline calendars to estimate deadlines for future submission cycles
- Danielle Beaudry in the R&D Office keeps track of local submission dates for Merit Review grants, Richard Lightfoot, also in the R&D Office, keeps track of local submission dates for career development awards and research career scientist awards. Questions regarding deadlines, submission cycles and paperwork should be directed to them. Please click on the names to access contact information Danielle Beaudry or Richard Lightfoot.
General Research Information
Research and Development Program Overview (VA Directive 1200)
Responsible Conduct of Research at the VA Portland Health Care System (VAPORHCS), 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)
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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