VINCI data services

HSR&D Cyber Seminar

February 27, 2011

VA Informaticsand C ti ompu ng

Infrastructure
Agenda

 What is VINCI (quick review) VINCI data VINCI data services Planned enhancements/new featur Questions?
Quick VINCI Review

 Secure analytical workspace for VA 

researchers

 D di t d hi h f h d D

edica

t

ed hi

gh per

formance har

dw

 Software tools, custom application

 Access to data analysis software to RDP connection 

– Cloud computing

 Analysis and development workspa Most complete collection of VA dat Staff to assist you
VINCI Data Center

 Located within AITC Many large, high performance serv Hundreds of terra bytes of high 

performance SAN

 Newly improved networking Dedicated system administrators Regular data backup and archiving
VINCI Software

 SQL Server SAS, including high performance SA Stata, PASW(SPSS), 

R

 MS Office tools Other publishing software NLP t l NLP tools

 Other software can be 

purchased
VINCI Data

 CDW production data – Vitals Phar

Vitals, Phar

Lab, many more

 CDW R d t CDW Raw data – TIU R di l Al

TIU, Radiology, Al

 DSS NDEs – SAS and SQL format

 Med SAS – SAS and SQL format Vital Status
VINCI Data Services

 Data needs assessment Preparatory to research work Cohort selection Data extraction Formatting, indexing & security R d t l i & t d di i Raw d

a

t

a

cleaning & 

stan

dardi

zing

 Data descri

ption documents

 Project tracking system
Data Needs Assessment

 Consultation with your study team to 

you for making a DART request

 Query development and to find estim

cohort size

 M lti l i l t d t l 

Multi

ple

simple t

o mo

dera

t

ely com

aggregations provided

 We can assist with determining wh

sufficient sam

p 

le size is available f

study

 Check the data description docs fir
Preparatory to Research W

 All the services of the Data needs ass

plus more

 Primarily used to check study feasibil More complex and thorough aggregat

provid de

d

 Your own work database in VINCI Use of the VINCI Workspace and all th Access to individual data records a

Access to individual data records, aneeded
Cohort Selection

 VINCI data manager creates patien

based on research users' inclusion aexclusion criteria

 Collaboratively define moderately 

rul f h fl les 

for co

hort creation, 

filtering 

 Custom scri

pg p tin

g of rules into o

ptim

SQL code

 Cohorts can be created containing 

column for each rule or combinatiorules using multiple domains rules, using multiple domains
Data Extraction

 Research study team receives proj

approval from NDS

 D t t d i l di D

a

t

a access group crea

t

ed includin

research study team participants

 Used for granting access to data & w

 Research stud

y team receives alert

the correspondence site has been c

 All communication takes place on the  Correspondence Site is easy to use
Data Extraction
Data Extraction

 Research study team uploads coho

secure site or VINCI creates cohort requirements

 Research study team completes th

self d ection 

forms on correspon

dence 

 NDS approved data domains are ex

and provided in your own high performance SQL Server database

 Analysis performed by research pro

team staff
Formatting indexing & sec

Formatting, indexing & sec

 Data can be transformed to multip

formats as needed

 D t b b d f 

D

a

t

a

bases can b

e accessed from an

tools

 Consultation regarding query tuning Adding indexes to your data Only your study and the VINCI data 

managers will have access to your database
Raw Data Cleaning & Standard

 Performed on all CDW Raw domain

Performed on all CDW Raw domainRadiology, Allergies, etc.

 D t t ti i ti D

a

t

a type opti

mization

 Naming standardization

 Data content standardization Indexes added Keys added for easier joins
Data Description Docume

 Information on domains including 

Information on domains, including variable and variable descriptions contained within each table availacontained within each table, availaVINCI’s website

 Incld d d 

lu

des CDW Pro

duction an

d RAW 

 Re

p g acka

ged VistA FileMan descri

pt

tables and columns

 Lineage from VistA to CDW to your 

database
Data Description Docume

http://vaww.vinci.med.va.gov/vincicentral/dat
Project tracking system

 VINCI data team uses a project tra

system to manage your project

 P j t d ti ti iti f 

Project duration, time waiting for hours spent on your project by VINnotes written b d y VINCI, 

domains 

extracted, number of records

 Information can be made available 

project team

 Develop progress and management 
Project tracking system
Project tracking system
Project tracking system
Enhancements/New Featu

 Knowledgebase System Cleaning and standardizing data Creation of “Less Identifiable” dat

domains

 Metadata & data profile reports Data analysis cubes Aggregate reports Cohort selection tools
Poll Question

 Which new features do you want to 

made available in VINCI data servicA. Knowledge baseB. Cleaning and standardizing dataC. “Less identifiable” data domainsD. More metadata & data profile infoE. Analysis cubes & aggregate reportsF. Cohort selection toolsG. Other (Please specify using Q/A option)
Questions?

Contact Information:vinci@va.govhttp g ://vaww.vinci.med.va.gov/vincicen
2/27/2012 12:00pm VA Informatics and Computing Infrastructure 

Saoudian, Hamid VINCI Data Services

Q: For data that is available through the SAS files in Austin, is the data available in the same format? 

For data not available in SAS format through Austin, are there guides to the data formatting?

The data in CDW are generally in SQL format. VINCI data managers can provide most of the data in 

either SAS or SQL formats. The “Austin SAS files” generally refers to the DSS or MedSAS data. Both 

these sources are originally SAS format, but can be provided in SQL also.

Q: Is it possible to get a copy of the naming standardization you have in place?

Standardization is really a VHA-wide activity. The group responsible is Standardization and Terminology. 

There is a subgroup for Lab standardization and a pharmacy group. The best source of information is 

VIReC - the VA Information Resource Center.

Q: Please elaborate in more detail regarding data standardization - we were told that help was NOT 

available with this. We want only plasma or serum glucose levels, for example.

The VINCI data management group will try to assist with identification of the correct data for a study. 

But standardization, especially of Lab data, is a VHA-wide effort. The best source of information is VIReC 

- the VA Information Resource Center.

Q: When researchers create projects, they don't necessarily want nor need involvement by the VINCI 

data managers, i.e., what is to prevent "rogue" VINCI data managers from corrupting or damaging 

research stored on the servers? In many research studies also, many IRBs DO NOT accept external 

and non-approved personnel from having access to a researcher's work product.

The permission to access data from the CDW and some other data sources is granted through National 

Data Systems (NDS). There are other sources of data and other data stewards in the VA. The VINCI data 

managers have been given rights to provide data for research projects as directed by NDS. Researchers 

do not have access to the CDW. If the IRB requires data to be accessed only by those named on the IRB, 

the project would be limited to local or regional data sources, if available, and as approved by those 

data stewards.

Q: Are the data provided 21 CFR Part 11 compliance? If can be made so?

Q: Will the RAW data be eventually productionized so that it will have the same availability as the 

production dataset?

Yes, the CDW RAW files will be modeled and moved to CDW Production.

Q: How is missing data handled?

Data quality and data cleaning are still largely the responsibility of the user. Efforts throughout the VA 

are underway to improve data quality, but there is no systemic source of “clean” data. VIReC (VA 

Information Resource Center) is your best source of information about data and the quality of the data.

Q: You said that researchers can bring data into VINCI, is there some sort of data use agreement (DUA) 

in place to protect the researcher's primary data? Does the data become property of VINCI?

VINCI is not a data “owner”. According to our mission, we prevent the download of data that can be 

identified with a patient (PII/PHI) without written permission of Dr. Seth Eisen, head of HSR&D. If one 
2/27/2012 12:00pm VA Informatics and Computing Infrastructure 

Saoudian, Hamid VINCI Data Services

imports/uploads data to the VINCI servers for analysis, one may keep a copy of the data. Downloading 

of aggregate/summary data or results/graphs/figures/manuscripts is always permitted.

That said, VINCI is a Research Data Repository, and can make available derived data with the proper 

approvals. Derived data may be datasets created by combining other data, or data that is produced by 

research activity, an example of which would be annotated medical records used to train NLP tools. 

These are the only data that would be specific to VINCI as a repository.

Q: Would it be possible to have our own 'honest data brokers' to access CDW data and abstract the 

data ourselves, without help from VINCI staff?

Data access permissions for the CDW are determined by NDS. At this time, researchers are not allowed 

access to the CDW. It is still possible to access certain data on the mainframe in Austin. Those 

permissions are also handled by NDS. 

Q: Are Inpatient medications available in sql format through VINCI?

In-patient and outpatient pharmacy are available from CDW (SQL format). The PBM database is 

available for research with permissions directly from PBM.

Q: ...and are radiology notes subject

??

Q: Can we have access to microbiology (lab) data?

There is currently available a database of microbiology data (organism, sample, antibiotic, 

resistance/sensitivity). These data are not part of CDW, but can be used for research with oversight by 

NDS. Please contact Tori Barrett (victoria.barrett@va.gov) for more information.

Q: Do WOC appointees get the same level of access or priority to VINCI services?

Yes.

Q: What does the data look like in VINCI? For data that is available through the SAS files, is it similar in 

format to the SAS files?

Most data are available in both SAS and SQL format.

Q: HI. Do you have any ongoing telepatholgy projects i.e. whole slide imaging, etc 

No image data are currently available in the CDW.

Q: How do we upload our own data to VINCI workspace?

Data are uploaded by ftp (file transfer protocol). Instructions are available on the VINCI Website –

vaww.vinci.med.va.gov/vincicentral.

Q: How do we delete a study workspace on VINCI?
2/27/2012 12:00pm VA Informatics and Computing Infrastructure 

Saoudian, Hamid VINCI Data Services

There are rules in the VA about deleting/maintaining data. The VINCI staff will assist with the archiving 

of data that must be retained. Otherwise, a workspace can be deleted simply by notifying VINCI staff at 

vinci@va.gov.

Q: How frequently is the data backed up? If uploaded by user

Data are backed up nightly and archived to tape weekly. Data, whether materialized by VINCI staff or 

uploaded by a project’s staff are backed up in Project folders nightly.

Q: How frequent the data is updated to date through VINCI?

CDW data are updated nightly. There are many other sources of data that are updated on specific 

schedules. For example, the TIU (note) data are a VistA extract and are currently extracted annually.

Q: How is VINCI working with other VA or VHA offices in terms of things like data standardization, 

metadata development, etc?

The major data standardization efforts are through the Standardization and Terminology office. VIReC is 

the best source of information about the quality of data for research.

Q: How long does it now take to go from first contact with VINCI to project approval and to having 

data ready for analysis?

Access to data is granted by approval from NDS. That process depends on the nature of the request, the 

complexity of the data and the number of other applications that are in process at the same time. A 

complete and accurate data access application certainly speeds up the process. Once a project has 

approval for a set of data, the VINCI data managers will contact the research team within 2 business 

days. The time it takes to have data ready for analysis depends on the complexity of the request.

Please remember that access to the Austin mainframe is also granted by permission from NDS. Once a 

group/person has permission to access the mainframe, their acquisition of the data proceeds at their 

own pace.

Q: If we create a Microsoft document in VINCI how do we move it our local computer? Email? Or...

Files are downloaded from VINCI through a utility called File Transfer. We use this utility in order to 

copy and audit all files that are downloaded. The VINCI policy states that no files containing PHI/PII may 

be downloaded. Otherwise, any aggregated/summary/results data or figure/manuscripts may be freely 

removed using the File Transfer utility.

Q: How much storage is available for individual researcher's data tables?

There is currently more than 500 TB of storage available. We do not limit individual project storage.

Q: How should our IRB and VINCI interact? 
2/27/2012 12:00pm VA Informatics and Computing Infrastructure 

Saoudian, Hamid VINCI Data Services

If a project will use the VINCI environment (servers, software, storage), the IRB needs to specify VINCI as 

the location of the data. Suggested wording for the IRB can be found on VINCI Central 

(vaww.vinci.med.va.gov/vincicentral) under the library tab.

Q: How to access TIU? What format is the data for TIU?

TIU are text documents. One requests permission for TIU through NDS just as other CDW data.

Q: How to get approval for Preparatory to research work? 

Instructions for Preparatory to Research permissions are on the NDS website.

Q: Are Pathology reports available in CDW Raw?

Pathology reports are not currently available in CDW.

Q: I have formed a work group in VINCI, but am I supposed to have a VINCI member on my study

team? 

No. Please do make sure that you have VINCI Workspace access and not just a Study Registration 

collaboration site.

Q: How will VINCI intersect with the work of the open source communities?

The VINCI group that is doing custom software development for Natural Language Processing (NLP), 

Annotation/Chart Reader and Information Extraction uses all open-source tools. All VINCI custom 

software is open-source.

Q: Would you say that standardizations of the core legacy applications such as lab, pharmacy is a key 

dependency on pulling national data thru VINCI?

The office of Standardization and Terminology is charged with the standardization of data throughout 

VHA. VINCI is not part of this office.

Q: How does data validation occur in Vinci?

VINCI staff is not responsible for data validation. Please refer to VIReC for information about data 

quality in VHA.

Q: If we do all the work ourselves, create cohort, pull the data. Do we need to submit DRAT 

application as well?

All access to CDW, and some other data sources, is handled through NDS. It is the responsibility of the 

data steward to grant access to data for research. Researchers do not have access to the CDW so 

cannot “pull data”. If a project is accessing local sources of data, or other sources not controlled by NDS, 

one must contact the steward for those data for approval. VIReC provides information about sources of 

data available for research and the process to access those data.
2/27/2012 12:00pm VA Informatics and Computing Infrastructure 

Saoudian, Hamid VINCI Data Services

Q: is it possible to create a cohort using data from both the production and RAW datasets (linked by 

ssn or some other Unique Identifier)?

Yes. There are several ways to link data from CDW and other sources. The CDW uses an IEN unique 

identifier but it can be cross-walked to other identifiers used in other sources.

Q: Do the TIU snapshots contain full text from all CPRS documentation notes?

Most, but not all, text data in VistA are stored in TIU. Each station has peculiarities. One cannot 

guarantee that all notes are in TIU.

Q: do we need IRB approval prior to applying for VINCI access?

It is possible to have a VINCI Workspace (access to servers, software, storage) without an IRB. If a study 

is getting data from CDW (with permissions from NDS), we will generally create a workspace for your 

project when your data access request is approved. If you are bringing in your own data or simply want 

to “explore”, you may set up a workspace in advance. Please see VINCI Central for instructions. 

(vaww.vinci.med.va.gov/vincicentral)

Q: Do researchers need to be able to write perl, sql, etc in order to perform queries on the provided 

dataset?

The data can be provided in SAS or SQL format. VINCI staff do not do any analyses, they can, though 

provide data in Access or some other formats if requested.

Q: Is the idea that the data analysis cubes, aggregate reports, less identifiable domains, etc would not 

require NDS permission/approval?

No. All CDW data access currently required NDS approval. Please remember there are many sources of 

data in VHA and other sources may have their own data steward responsible for approving access for 

research.

Q: Could explain "knowledge base" briefly again? I apologize...I did not hear that description.

A compilation of information regarding VA research data and other related concepts and issues. The 

information in the knowledgebase is accessible to all VA research staff, VINCI staff and others with 

interest in VA research data. All knowledgebase users can contribute and add information to it. It will 

be maintained and moderated by VINCI staff.

Q: Is tumor registry in CDW too?

CDW does not have the tumor registry data. The VINCI data managers can help you link those data with 

CDW data but you must work with the data steward for the tumor data to gain access for your project.

Q: What's the sequence for approval? Which one comes first? DART or VINCI. I got an VINCI access 

approval for a project, but still waiting for the DART approval for 6 weeks already.
2/27/2012 12:00pm VA Informatics and Computing Infrastructure 

Saoudian, Hamid VINCI Data Services

It is possible to have a VINCI Workspace (access to servers, software, storage) without an IRB. If a study 

is getting data from CDW (with permissions from NDS), we will generally create a workspace for your 

project when your data access request is approved. If you are bringing in your own data or simply want 

to “explore”, you may set up a workspace in advance. Please see VINCI Central for instructions. 

(vaww.vinci.med.va.gov/vincicentral)

Just a polite reminder, the NDS process is independent from VINCI. DART is the workflow application.

Q: Is VINCI only available to researchers? If we need data sources for non research projects can we 

still utilize VINCI?

VINCI is the analytical platform (servers, software, storage). It is available for use by Researchers and 

non-researchers.

Q: Do you include SPSS, in addition to SAS?

SPSS is available as are more than 50 other commercial and custom software applications. Please see 

VINCI Central (vaww.vinci.med.va.gov/vincicentral) for a complete list.

Q: please provide link to virec?

The VIREC site can be reached at: http://www.virec.research.va.gov/ 

Q: This is my first time joining. I am unfamiliar with this service. Is there a website I can go to learn 

more specifics?

Please start with VINCI Central vaww.vinci.med.va.gov/vincicentral

Q: through the presentation, VINCI sounds serving for 'research' purpose. Can we get data through 

VINCI for operational project, e.g., quality improvement project? For instance, can we get adverse 

event incidence report owned by National Center of Patient Safety through VINCI to work with local 

patient safety managers to improve the safety of the care?

VINCI is the analytical platform (servers, software, storage). It is available for use by Researchers and 

non-researchers. There are many sources of data throughout VHA. One must work with the steward of 

the specific source of data to obtain permission for use. This is generally true for both research and 

operations. Please work with the steward for the National Center of Patient Safety to obtain permission 

for use of the data. VINCI data managers may be able to assist with materialization of those data once 

approved.

Q: What is the process for getting approval to get data?

There are many sources of data throughout VHA. One must work with the steward of the specific 

source of data to obtain permission for use. The data steward for CDW and a number of other 

commonly used data sources is NDS. Please see the NDS website for instructions.

Q: You encourage storage of data; where?
2/27/2012 12:00pm VA Informatics and Computing Infrastructure 

Saoudian, Hamid VINCI Data Services

VINCI is an analytical platform (servers, software, storage). If using the VINCI Workspace, your data will 

be stored and backed up by the VINCI systems administrators. If you use the VINCI Workspace for a 

research project your IRB needs to identify VINCI is as the location of the data.

Q: Has a privacy officer evaluated whether the VINCI data has been de-identified with respect to 

HIPAA regulations?

There is no source of de-identified data in the VA. CDW data are fully identified.

Q: Will we have direct access to the Med SAS, vital status, DSS NDE data? Right now, we go directly to 

those files (mainframe) to develop our own cohorts. Will we be able to do that, or will we have to go 

through a VINCI analyst to get the data for us. We are concerned about the extra time and complexity 

involved in adding another layer of people to our projects.

All access to CDW, and some other data sources, is handled through NDS. It is the responsibility of the 

data steward to grant access to data for research. Researchers do not have access to the CDW so 

cannot “pull data”. If a project is accessing local sources of data, or other sources not controlled by NDS, 

one must contact the steward for those data for approval. VIReC provides information about sources of 

data available for research and the process to access those data. At this time, researchers are not 

allowed access to the CDW. It is still possible to access certain data on the mainframe in Austin. Those 

permissions are also handled by NDS.

Q: What application do we need to submit in order to use VINCI to store and analyze our own data 

(not VINCI data)?

If one would like to use the VINCI Workspace (servers, software, storage) just see VINCI Central 

(vaww.vinci.med.va.gov/vincicentral) for instructions. It is a simple ftp to bring in data for which a 

project has permission.

Q: If we load our own data into VINCI, are we allowed to download the data back to our personal 

computers?

If one imports/uploads data to the VINCI servers for analysis, one may keep a copy of the data. 

Downloading of aggregate/summary data or results/graphs/figures/manuscripts is always permitted.

Q: Can the presenter eventually review a 'typical timeline' for getting data from VINCI?

Access to data is granted by approval from NDS. That process depends on the nature of the request, the 

complexity of the data and the number of other applications that are in process at the same time. A 

complete and accurate data access application certainly speeds up the process. Once a project has 

approval for a set of data, the VINCI data managers will contact the research team within 2 business 

days. The time it takes to have data ready for analysis depends on the complexity of the request.

Please remember that access to the Austin mainframe is also granted by permission from NDS. Once a 

group/person has permission to access the mainframe, their acquisition of the data proceeds at their 

own pace.

Q: If I don't have access to the VA intranet, can I still see the data description?
2/27/2012 12:00pm VA Informatics and Computing Infrastructure 

Saoudian, Hamid VINCI Data Services

No.

Q: In the cohort identification process, is it possible to reconstruct a consort figure?

We need more information to be able to answer – please contact us at VINCI@va.gov

Q: Would we be allowed to download CDW data from VINCI into our computers if we originally 

requested to have CDW data downloaded into our computer?

NDS approves requests for access to data. The request must specify where the data are to be 

stored/used. It is possible to obtain permission for access to data on local research servers.

Q: Who are VINCI data managers? How can we contact them?

Please see VINCI Central for contact information. vaww.vinci.med.va.gov/vicnicentral

Q: Are you radiology reports and radiology orders available in the CDW?

Yes.

Q: How frequently the data id backed up?

Data are backed up nightly and archived to tape weekly. Data, whether materialized by VINCI staff or 

uploaded by a project’s staff are backed up in Project folders nightly.

Q: Will your infrastructure match that of OnLive Desktop for Apple Ipad? They have 1-gigabit Internet 

and can download 20 MB file in a second.

No

Q: There is a big problem in using the lab data. Lab values and names exist in the database just as 

they were created in individual VA facilities. Researchers may want to study glucose levels, for 

example. But there are 2000 different names of glucose tests (we've obtained a list).

The VINCI data management group will try to assist with identification of the correct data for a study. 

But standardization, especially of Lab data, is a VHA-wide effort. The best source of information is VIReC 

- the VA Information Resource Center.

Q: Do you have endnote software?

Yes, but VINCI is not open to the internet so some functionality of Endnote is not available.

Q: Can we have access to Freeware (free software) through VINCI? What is the process?

It is possible to bring in your own software. When you request access to VINCI Workspace, the staff will 

ask you about the software you need for your work. If you need to bring in specialized software we will 

create an isolated workspace for your use so that your software cannot affect the system.

Q: How do we request software purchases? What is the timeline for these purchases?

VINCI is funded to provide software on request, but each request is evaluated in light of budget, utility 

to others and operability. The procurement process in the VA is long and convoluted. 
2/27/2012 12:00pm VA Informatics and Computing Infrastructure 

Saoudian, Hamid VINCI Data Services

Q: If a researcher has access to VINCI data, does he still need to request access to mainframe account 

separately? Thanks.

VINCI is the analytical platform (servers, storage, software). If you have been given access to CDW data 

for a project, the VINCI staff will help materialize those data either in the VINCI Workspace or to your 

local server as instructed by NDS. Most data that can be obtained from the mainframe are available 

from CDW.

Q: medSAS and DSS data are the same with that in AITC?

Yes, except that they can be provided from CDW in SQL format as well.

Q: Please provide more information about help available with data cleaning - this is a big problem for 

us.

The VINCI data managers have experience with the data used for research so that they can provide 

some suggestions about the quality of the data. Please see VIReC for more information about data 

quality.

Q: Does Vinci currently support neuroimaging analysis (e.g., structural or functional MRI)?

CDW does not have any image data.

Q: How long does it take to get permission from DART in general?

Access to data is granted by approval from NDS. That process depends on the nature of the request, the 

complexity of the data and the number of other applications that are in process at the same time. A 

complete and accurate data access application certainly speeds up the process. Once a project has 

approval for a set of data, the VINCI data managers will contact the research team within 2 business 

days. The time it takes to have data ready for analysis depends on the complexity of the request.

Please remember that access to the Austin mainframe is also granted by permission from NDS. Once a 

group/person has permission to access the mainframe, their acquisition of the data proceeds at their 

own pace.

Q: What about researchers that only need a codebook and access to VINCI? In other words, what 

provisions are being made to accommodate advanced researchers?

All access to CDW, and some other data sources, is handled through NDS. It is the responsibility of the 

data steward to grant access to data for research. Researchers do not have access to the CDW so 

cannot “pull data”. If a project is accessing local sources of data, or other sources not controlled by NDS, 

one must contact the steward for those data for approval. VIReC provides information about sources of 

data available for research and the process to access those data. At this time, researchers are not 

allowed access to the CDW. It is still possible to access certain data on the mainframe in Austin. Those 

permissions are also handled by NDS.

Q: What is needed is for VINCI staff to develop ways to make identification of commonly used tests 

more convenient for researchers. Is this possible, and if so, who should we work with? This would 

help lots of investigators, so each group doesn't have to "reinvent the wheel" with this.
2/27/2012 12:00pm VA Informatics and Computing Infrastructure 

Saoudian, Hamid VINCI Data Services

Standardization is really a VHA-wide activity. The group responsible is Standardization and Terminology. 

There is a subgroup for Lab standardization and a pharmacy group. The best source of information is 

VIReC - the VA Information Resource Center.

Q: Can NLP be used on radiology notes?

Yes. VINCI can provide some custom NLP tools.

Q: Will the data manager extract the cohort data in SAS format or SQL format?

Both formats are possible.

Q: Does a project need to have a well-defined cohort criteria from the beginning of the data 

abstraction? Can cohort be modified over time?

A cohort can be modified over time and VINCI data managers can help with cohort identification.

Q: Is it possible to have extracted data provided in another format other than SQL Server database 

(e.g. SAS or STATA)?

All SQL data can be provided in SAS format. May “native” SAS datasets are available. In general, SAS 

data sets can be used with most other analytical software programs such as Stata.

Q: What are the steps for getting NDS approval...is there a website with forms, etc.? 

Please see the National Data Systems (NDS) website.