Linda Kok, MA

September 11, 2013

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Good Data Practices

 Series Recap

 Session 1: Early Data Planning for Research 

 Session 2: Managing and Documenting Data Workflow

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Session 3: Planning for Data Re-use

 Data activities at project close

 Why make research-generated data available for re-use? 

 Policy on sharing data for re-use 

 Planning for sharing data for re-use 

 Documentation required for re-use 

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Poll Question #1

 Are you planning or already working on a project that will 

produce a dataset that might be shared for re-use? 

 Yes

 No 

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Session 3: Outline

 Data activities at project close

 Why make research-generated data available for re-use? 

 Policy on sharing data for re-use 

 Planning for sharing data for re-use 

 Documentation required for re-use 

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Data activities at project close

 Data handling at project close 

 Decision to share data for re-use

 R&D Committee notification 

 IRB permission/notification

 VHA records retention requirements for research data

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Data activities at project close

 VHA records retention requirements for data

 What to retain?

 Analytic dataset

 Unique source data

 How long to retain?

 VHA 1200.05 Requirements for the Protection of Human 

Subjects in Research: 

 Retain secured copy of select dataset(s) until a record control 

schedule for VA research data is created. 

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Data activities at project close

 Example: Project closure process –Hines VA Hospital

 Turn in study data disks to the research office – if any exist

 Discontinue using identifiable data

 Request that IT staff remove research access & secure data 

on network server

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Session 3: Outline

 Data activities at project close

 Why make research-generated data available for re-use? 

 Policy on sharing data for re-use 

 Planning for sharing data for re-use 

 Documentation required for re-use 

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Why make research-generated data 

available for re-use? 

“Every day, we create 2.5 quintillion bytes of data — so 

much that 90% of the data in the world today has been 

created in the last two years alone. “ 

August, 2012 – IBM, Bringing Big Data to the Enterprise

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Why make research-generated data 

available for re-use? 

 Reduce, Reuse, Recycle! 

 Reduce redundant (expensive) data preparation

 Reuse existing research data

 Recycle subsets of research data 

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Why make research-generated data 

available for re-use? 

National Institutes of Health: Goals of data sharing 

 Permit access to unique data 

 Expedite the translation of research into knowledge, products & 

procedures

 Permit testing of new alternative hypotheses & methods

 Support methods and measurement studies 

 Facilitate the education of new researchers 

 Reinforce open scientific inquiry

 Comply with funder requirements 

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Why make research-generated data 

available for re-use? 

 Why make your data available for re-use? 

 To re-use the data yourself 

 Promote your research

 Enable new discoveries with your data

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Session 3: Outline

 Data activities at project close

 Why make research-generated data available for re-use? 

 Policy on sharing data for re-use 

 Planning for sharing data for re-use 

 Documentation required for re-use 

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Policy on sharing data for re-use 

• NIH Data Sharing Requirements 

• All data should be considered for data sharing

• Applications > $500,000 must include data sharing plan 

• Data should be 

• Widely & freely available 

• With timely release and sharing

• While protecting patient/subject privacy

 NIH guidance: 

http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm

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Policy on sharing data for re-use 

 VHA Policy on Data Re-use for Research

 Permits re-use of research-generated data within the VHA 

in an IRB approved research data repository 

 VHA Handbook 1200.12 “Use of Data and Data 

Repositories in VHA Research”

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Policy on sharing data for re-use

 Data sharing authorization checklist

 HIPAA compliant patient authorizations

 IRB approval of waiver of HIPAA authorization

 VHA data owners/steward permission

 Agreements with non-VHA data sources

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Session 3: Outline

 Review of planning and documentation 

 Why make research-generated data available for reuse? 

 Policy on sharing data for re-use 

 Planning for sharing data for re-use 

 Documentation required for re-use

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Poll Question #2

 Have you used public data from an external sources such 

as MEPS or ICPRS? 

 Yes

 No 

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Planning for sharing data for re-use

 Key Components of Data Sharing Plans 

 What data are to be shared?

 What is the authority to share for re-use?

 How will data re-use be approved?

 In what form will the data be shared?

 How will data be provided?

 How will data be protected? 

 Where will the data be stored? 

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Planning for sharing data for re-use

 What makes a good data repository host? 

 Data security

 Scheduled back-ups

 File recovery system 

 Adequate volume capacity

 Compatible data formats

 Long-term data retention capacity

 Data access provisioning capability 

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Planning for sharing data for re-use

 What makes a good VA data repository? 

 Data security

 Scheduled back-ups

 File recovery system 

 Adequate volume capacity

 Compatible data formats

 Long-term data retention capacity

 Data access provisioning capability

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Poll Question #3

 If there were a central research data repository available 

in the VHA, how likely would you be to share data from 

one of your research projects for re-use? 

 5 = Very likely

 4 = Likely

 3 = Maybe

 2 = Unlikely

 1 = Never 

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Session 3: Outline

 Data activities at project close

 Why make research-generated data available for re-use? 

 Policy on sharing data for re-use 

 Planning for sharing data for re-use 

 Documentation required for re-use

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Documentation required for re-use

 Importance of documenting as you go 

 Accurate, systematic record of the research process

 Captures decisions and the reasoning behind them

 Reduces mistakes, confusion and wasted time 

 Provides the basis for re-using data with confidence 

 It’s all in the details

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29 9/10/2013 

Details: ICPSR Data Deposit 

Form

Note:

• Codebook

• Data collection 

instruments 

• Data File Inventory
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Details: Documentation of 

derived variable in an 

analytic dataset. 

Note: 

• Source

• Description 

• SAS code 

From: “Impact of Medicare Drug Benefit 

on VA Drug Use, Healthcare Use and 

Cost”; Funding Agency: Department of 

Veterans Affairs Health Services Research 

and Development; Study Number: IIR 07-

165-2 - Kevin Stroupe, PI
Documentation required for re-use

Documentation checklist

 Project Description

 Title 

 Creator

 Identifier 

 Subject 

 Dates

 Funders 

 Location 

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Checklist continued on next slide...
Documentation required for re-use

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 Data description 

 File format

 File structure

 Variable list & description

 Variable format

 Code lists & definitions

 Derived variables description

Checklist continued on next slide...
Documentation required for re-use

 Methodology description

 Cohort definition

 Sources of data

 Data processing description

 Data linkages

 Cleaning processes

 Data issues found & resolution

 Creation of derived variables

 The reasoning behind each decision that formed your data and 

analysis

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Checklist continued on next slide...
Documentation required for re-use

 Study Citation 

 PI & affiliation

 Descriptive title study & data 

 Place & date of production 

 Organizational name of data producer 

 Sponsoring or funding agency and grant number 

 Person/organization responsible for collecting data

 Special collaborator(s) (if applicable)

 Contact person for questions about the data.

 Study Abstract

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Contact Information

Linda Kok, MA

VA Information Resource Center

A VA Health Services Research & Development Resource Center 

working to improve the quality of VA research that utilizes 

databases and information systems

Hines VA Hospital

VIReC@ va.gov 

708-202-2413 

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Session 3: Planning for Data Re-use

 Recap 

 Data activities at project close

 Why make research-generated data available for re-use?

 Policy on sharing data for re-use 

 Planning for sharing data for re-use

 Documentation required for re-use

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Session 4: Research Application

 Preview

 Proposal planning and development

 Funding, IRB, and Study Initiation considerations

 Documentation Content and Locations

 Study Design and Implementation

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