Va clinical database research



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VA CLINICAL DATABASE RESEARCH

Malcom Randall VA Medical Center


Introduction
Clinical database research is defined as retrospective research conducted using existing clinical databases, e.g., CPRS. It includes feasibility studies (determination of the size of the population of interest preparatory to conducting a prospective clinical study); the conduct of single medical center retrospective studies by established investigators, fellow, residents, or students; and the conduct of large, retrospective, multicenter database studies.
In the VA system, feasibility and single center studies of clinical databases (CPRS) have until recently been conducted via investigator queries to the Clinical Informatics Service. Several years ago, the VA Office of Research and Development (ORD) and the VA Office of Information and Technology (OI&T) jointly developed the VA Informatics and Computing Infrastructure (VINCI) to enable the conduct of multicenter clinical database studies. VINCI is a research platform that includes servers, licensed statistical software (e.g., SAS, SPSS, R), database management facilities, a regulatory infrastructure, and a large team of experts capable of assisting investigators at every stage of a clinical database research project. As VINCI has matured, its services have expanded to include the entire spectrum of clinical database research, including feasibility studies and small single center retrospective studies. At the same time, the Clinical Informatics Service, which we used to tap to run queries for single center studies, has become more and more burdened by clinical exigencies, reducing its ability to accommodate investigators. It is no longer available to us at the Malcom Randall VA Medical Center. VINCI, though still under development, has stepped into this breach. From henceforth, ALL clinical database research must be run using the VINCI platform.
For further information on VINCI, see accompanying document, “VINCI description for IRBs.” For information on VINCI database security, see accompanying document, “VINCI_Information_Security_Description.”
This document is intended to be a Wiki: as VINCI users gain experience with the system, it is expected that they will be able to provide useful information and insights that can be used to modify the document, thereby benefiting others. Please send suggested modifications to the ACOS/R, changes tracked.
Please note: all text links in this document and most URLs will work ONLY from a VA computer.
Comprehensive VINCI information sites:
Accessible only from a VA networked computer:

Vinci Central.
Accessible from any computer:

Vinci for researchers
Feasibility Studies
These are done entirely by VINCI staff. They no longer need IRB approval. VINCI will deliver total counts of the number of patients who meet the investigator’s inclusion and exclusion criteria. Turnaround time is approximately 2-4 weeks; however it could be more depending on the inclusion/exclusion criteria provided.
Procedure:

  1. Email vinci@va.gov: Subject line: “Feasibility Request

  2. Body of email:

    1. Station number (e.g., for Malcom Randall VAMC, 573)

    2. List of inclusion and exclusion criteria

    3. Dates

    4. ICD 9/10 codes

    5. Any other additional information relevant to the request

Retrospective Clinical Studies (local, multi-center, or national)


Procedure:

  1. Obtain approval to conduct human subject research through Research Office Human Research Protection Process (HRPP) team. This will involve completion of VA mandated documents and the IRB packet, approval by IRB-01, and approval by the VA Research and Development Committee.

  2. Complete VINCI Data Access Requester Tracker (DART) process.

    1. Preparation: essential documents

      1. Research request memo (required for MedSAS files including VetNet files)

      2. Research study protocol

      3. Research and Development Committee Approval Letter(s)

      4. Institutional Review Board (IRB) Approval Letter(s)

      5. IRB Approved HIPAA Authorization or Waiver of HIPAA authorization

      6. IRB Approved Sample Informed Consent or Waiver of Informed Consent

    2. Guidance:

      1. Optional - Prior to submitting your IRB, you might want to have a VINCI Concierge work with you on a “Data Needs Assessment” to determine exactly what data you need to request. This may add a week or more to your process as VINCI staff may be very busy with other customers. If you wish this, just send as much data detail as possible to VINCI@va.gov and we will initiate the request for you. See these pages for information on data first:

        1. VHA Data Portal: 

vha data portal Data Sources Overview.aspx

        1. VINCI/Corporate Data Warehouse (CDW) Data Descriptions:

 http://vaww.vinci.med.va.gov/VinciCentral/DataSources/Index

      1. Optional if you intend to use VINCI Workspace for data storage and analysis - As part of your IRB, you will want to state that you are using VINCI for data storage and analysis. Just an FYI – VINCI does not approve access to data, it just provides data fulfillment once National Data Systems (NDS) approves access. Boiler-plate descriptions for use in your documentation: “VINCI Description for IRBs” and “VINCI Information Security Description”.

      2. Create your protocol and get your local IRB and R&D committees to approve. You will need an IRB and R&D approved protocol from each location where an investigator is involved.

      3. If you need Real SSN access, you will need to submit a Real SSN Access Request form to your IRB for signature.  Please visit VIReC’s information page on this: Virec Access Real-SSN-Request-Process

      4. Initiate your Data Access Request Tracker (DART) request. One of the purposes of DART is to specify exactly what documentation is required based on a series of inputs such as who will be accessing the data and what data sources you are requesting. Once you upload the required documentation, submit your request. It is recommended that you initiate a request immediately and input your study information so you will know what documents are required up front. Please note that not all data sources are available through a DART request. The VHA Data Portal will indicate the process for each data source but all CDW/VINCI data are available through DART. Here is DART information:

        1. DART application online site where you initiate your request using your VA username (without VA domain) and VA password to login – vinci_dart_client

        2. DART Overview and Forms: DataAccess DART Request Process

        3. DART User Guide – DART_User_Guide.pdf

        4. If you are requesting mainframe access, you will need to submit a 9957 to your local CUPS POC prior to completing your Research Request Memo.  See Appendix B in the DART User Guide on how to fill-out the 9957.

      5. Once NDS has approved your request, VINCI will be automatically notified and a VINCI Data Manager will work with you one-on-one to make the approved data available as soon as possible. As indicated in the DART approval email, VINCI will automatically create access to the VINCI Workspace.

      6. If you are using the workspace, login and conduct your analysis.

        1. See the VINCI Workspace User Guide (VINCI_Workspace_User_Guide.pdf ) for information on accessing and using the Workspace.

        2. See the VINCI File Transfer Guide (VINCI_File_Transfer_Guide.pdf ) for information on uploading and downloading files from the Workspace. Please note that at this time you cannot remove any data from the VINCI Workspace that contains PHI/PII per VHA rules without first obtaining NDS permission by way of a DART amendment.

        3. See the VINCI Database User Guide (VINCI_Database_User_Guide.pdf ) for information on interacting with databases from within VINCI.

    1. Data Acquisition Process:

Your research project will require permission from 3 entities to gain access to VA VINCI/CDW data: IRB, R&D and NDS. You are probably familiar with the IRB and your local Research and Development office can advise you about getting VA R&D permission. To get approval from NDS, the VINCI/CDW data steward, you will initiate a DART data request, enter detail about your project team and data sources, and upload your IRB and R&D approval letters and other documents to the DART application. Here are 3 links for information about the online DART application:

DART Home: Vinci_dart_client

DART User Guide: Vinci Central documents DART_User_Guide.pdf

Data access forms: DataAccess DART Request Process.aspx



The DART Home link takes you to the DART application where you can start your DART data request. The User Guide provides detailed instructions for preparing an online DART filing. The Data Access Forms (named the DART Request Process page) provides links to the forms you will need to upload to DART.

    1. When you receive a data access approval email from NDS, within 5 days you will be assigned a VINCI Data Manager. The Data Manager will work with you and provide guidance regarding the data you need (or link you up with knowledgeable experts — VINCI is still evolving and as it does, it is devolving certain responsibilities to other organizations, e.g., the VA Information Resource Center (VIREC)). The Data Manager will then build a Microsoft SQL Server database for you on a VINCI server. The purpose of the SQL database is to extract the particular dataset you want from the relevant VA clinical database (CPRS local, regional, or national). SQL queries serve to filter, extract, join, and summarize your data into a format from which you can accomplish the aims of your study. When the database is built, the VINCI Help Desk will grant access rights to you and your approved study team members and give you access to a VINCI virtual desktop. You can then access your database using the software available to you through the VINCI desktop.

SQL Tutorial: w3schools.com


General Data Questions:

As far as the data questions go, we have a Data Specialist, Jim Potter, who can help answer those questions based on your inclusion/exclusion criteria. To initiate what is called a Data Needs Assessment, you can email VINCI@va.gov with the data questions and the ticket will be filtered to Jim for assistance.


Assistance:

Ron Simpson

VINCI Concierge Services

VA Informatics and Computing Infrastructure (VINCI) Resource Center

VA Salt Lake City Health Care System

801-924-2132

Ronald.simpson@va.gov
Or VINCI@va.gov , Subject line: DART Assistance

Version 1.2 10/6/16


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