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Data Collection, Storage and Transmission
Research 201 May 9, 2019
Jennifer Bonifas, DOM IT Director
Adam DeFouw, DOM Information Processing Consultant
Shari Zeldin, DOM Compliance and IRB Officer
Data Classifications
• Public• Internal• Sensitive• Restrictive
IT Operations considers all data, that is not public, to be restrictive ( as in containing PHI)
IT Operations
• DOM IT is accountable and responsible for the security of all data
• Faculty and staff primary appointment with the University dictates which department IT provides services
i.e. Divisions, Centers and Institutes
IRB Data Types
• Identifiable- the identity of the subject can be readily ascertained
• Coded- direct identifiers have been stripped from data and replaced with a study ID or code, which can be linked to identifiable information.
• De-Identified – identifies that were connected to the research data during collection have been permanently removed
The workflow and security plan you have in place depends on what kind of data you have
Data Storage
Ensure data is securely stored• Shared Drive (or Folder)
i.e. If data is coded, the file linking the code to identifiable data must be separate from coded data, and it is articulated who has access to this file
Data Capture/Storage
• RedCap• nVivo• Customized applications- submit a request through
the ORS• Third party vendor applications
Adam De FouwREDCap Administrator
Department of Medicine
• What is REDCap?
– A secure web application for building and managing online surveys and databases
– Collects any kind of data• Tailored towards capturing clinical and operation support data
– A free-to-use tool for DOM users
• It’s NOT …
– a Relational Database• Complex data models not generally a good fit• Provides some limited “relational-database-like” functionality
– Supports repeating forms and instruments
– a Billing Platform• You will need other systems to handle this type of functionality
– a Workflow Solution• Does have some automation: emails, scheduling, surveys, and reports
– a Replacement for Good Study Design• REDCap won’t automatically give you good data• Adhere to best practices and solid experimental design to get good data• GIGO principle: Garbage In, Garbage Out
Common Uses & Project Types
Project Types
Project Requests for DOM REDCap
Obvious Conclusion:
REDCap is mostly used to support research projects
Project Types Supported
• Research– Basic or Bench Research– Clinical Research Trials– Translational Research– Behavioral or
Psychosocial– Epidemiology– Specimen Repository
• Operational Support• Quality Improvement Projects
• Survey– Public survey (unable to link to subject)– Individualized survey links (subject identifiable)
• Electronic Data Capture (in Project)– New Data
• Example : Entering clinical data directly into REDCap
– Existing Data• Example : Entering existing paper form data into REDCap
Common Uses
Public Survey
Characteristics:
• Data entered by anyone with link
• Same URL / link for everyone
• Participants NOT directly identifiable– Exception:
You ask identifying information within the survey
• Example: REDCap Project Request Formhttps://redcap.medicine.wisc.edu/surveys/?s=AWK73FTFTD
Individualized Survey
Characteristics:
• Looks the same as public survey to the person entering data
• Unique URL / link for every participant
• Participants are identifiable– You can override this, however
• Required to use: A list of email addresses for all participants
Direct Data Entry in Project
Characteristics:
• Entered only by authorized users with access to REDCap
• Uses the same form (instrument) as the surveys
• Administrator of Project:Granular control over data entry through User Rights / Permissions
Common Problems & Remedies
Common Problems & Remedies
DESIGN PROBLEM :
Inconsistent Coding of Yes / No options
– Solution / Best Practice: Yes = 1 No = 0– Good News: REDCap makes it easy to avoid incorrect coding!
Multiple ChoiceField Type
Yes – NoField Type
DESIGN PROBLEM :
Unconventional “Other / Unknown” Coding
– Solution / Best Practice: Other = 99 / 999 / 9999
– Why?• Separates option from standard choices• Allows for easy future expansion
Non-Standard, Unclear, Brittle Standardized, Clear, Future-Proof
Common Problems & Remedies
PROCESS PROBLEM :
Production Data Collected in Development Mode
Production data should NOT be collected until project is in Production Mode.
Why? Changes to instruments can cause:– DATA LOSS
- OR -– LOSS OF DATA INTEGRITY
How? If you make a change to a field:– REDCap does NOT UPDATE DATA when you update “field choices”– REDCap does NOT WARN you that this has happened (Development Mode)
SOLUTION:
Collect production data in PRODUCTION MODE:– In Production Mode, REDCap provides SAFEGUARDS against accidental loss of data– All instrument changes are reviewed by DOM REDCap team to prevent data problems
Common Problems & Remedies
Exporting Data
Data Export Capabilities
Data Export Best Practices
• Prevent Data Loss & Spread of PHI
DON’T• Export to your Computer’s Hard Drive
– If your drive fails, you lose your exported data– If your computer is lost or stolen, data is more vulnerable
DO• Export to Network Folder (i.e. G Drive)
– If your drive fails, you won’t lose your exported data» Network Folder is backed up on scheduled intervals
– If your computer is lost or stolen, exported data is not present
Data Export Best Practices
Identifier Fields
DON’T Forget to Mark Identifiers
DO Audit fields using Project Codebook
Identifier Examples:
1. Names
2. Postal address
3. Dates Telephone numbers
4. Fax numbers
5. Electronic mail address
6. Social security numbers
7. Medical record numbers
8. Account numbers
9. Health plan beneficiary number
10. Certification/license numbers
11. Vehicle identifiers and serial numbers, including license plate numbers
12. Device identifiers and serial numbers
13. Name of relative
14. Web Universal Resource Locator (URL)
15. Internet Protocol (IP) address number
16. Biometric identifiers, including fingers and voice prints
17. Full face photographic images and any comparable images
18. Any other unique identifying number, characteristic, or code
Data Transmission
• Never use email to transfer data sets!• RedCap is not a mechanism to transfer data• DOM has various data transmission solutions
– Encrypted & secure– filesend.medicine.wisc.edu is a secure service for
data transmission and enforces encryption – ZendTo is the product and filesend is the server
• DOM will provide how to describe this in your IRB application (and DUAs!)
HIPAA Risk Analysis of DOM
• Vulnerability: Agreements ( DUAs, BAAs, MOUs) that are signed by campus that are not reviewed by our IT department
• IT and Compliance need to review all agreements that involve research data in order to ensure there are data security plans in place to address control and technical safeguards
• All DUAs received by Betty via WISPER will be forwarded to the Compliance Officer and IT in order to ensure they are reviewed for data security compliance.
Data Sets and Security
Compliance Officer and DOM IT will:• Assist with data storage, data transfers, and security services• Ensure contracts and data security plans are congruent with the
contracts in WISPER (DUAs).
If you involve DOM IT at the protocol development phase, they can help provide you with appropriate solutions for data collection, storage and transmission
