EPI 218 Web-Enabled Research Data Management Platforms

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EPI 218Web-Enabled Research Data Management
Platforms
Michael A. Kohn, MD,MPP 29 August 2013
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Final Project Part ASend in or Demonstrate Your
Study DatabaseDue 9/18/2013

• Send in a copy of your research study database.
• We prefer a database that you are currently using
  or will use for a research study.
• However, a demonstration or pilot database is
  acceptable.

If you are unable to package your database in a
file to email, you can send us a link or work out
another way to review your database.
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Final Project Part ASend in or Demonstrate Your
Study DatabaseDue 9/18/2013

• If you are doing secondary analysis of data
  collected by someone else,
• obtain the data collection forms used in the
  original data collection,
• set up a new database that you would use for a
  follow-up study.

Often easily obtained by doing a Google search
or emailing the author of the original study.
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Final Project Part BSubmit Your Data Management
PlanDue 9/18/2013

• General description of database
• Data collection and entry
• Error checking and data validation
• Reporting (e.g., NIH Report)
• Analysis (e.g., export to Stata)
• Security/confidentiality
• Back up

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Final Project

• 1) What is your study?  ("The CUTE ACRONYM
  study is a DESIGN study of the association
  between PREDICTOR and OUTCOME in STUDY
  POPULATION").
• 2) What data points are you collecting?  (Your
  data collection forms.)
• 3) Who collects the data? You?  RAs?  MDs?  Chart
  abstractors? Maybe the study subjects enter the
  data themselves?

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Final Project (contd)

• 4) How are the data collected? Written onto a
  paper form and then transcribed into a computer
  database?  Entered directly into the computer? 
  (If data are transcribed, who does it? Have you
  hired/will you hire somebody? Or have you
  enlisted/will you enlist some med students?)
• 5) Will the above-mentioned computer database be
  in Access, REDCap, QuesGen, Oncore, OpenClinica,
  SurveyMonkey, Medidata RAVE, or something else?
• 6) Try to provide a detailed data dictionary with
  the name, data type, description, and validation
  rules for each field (column) in the data
  table(s).

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Final Project

• 7) If it's a multi-table database, even a
  hand-drawn relationships diagram would help but
  is not required.
• 8) How do you validate the data for correctness
  and monitor the data collection effort?  (Usually
  you have some range checks on individual
  variables and you periodically query for outliers
  that are nonetheless within the allowed range.)
• 9) You should periodically analyze the data, not
  only to look for problems, but also to see where
  the study is headed.  How do/will you do this? 
  Query in Access and export to Stata?
• 10) How will you protect your subjects'
  identifying data?
• 11) How will you ensure that you don't lose your
  data file in a computer crash or if a water pipe
  leaks?

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Answering these questions is an essential part of
doing a clinical research study.
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Main Options

• Access data collection forms, Access queries and
  reports for monitoring and reporting, with export
  to Stata for analysis (Labs 1,2,3)
• REDCap data collection forms, with export to
  Stata for monitoring, reporting, and analysis
  (Labs 4, 5)
• QuesGen data collection forms, QuesGen queries
  and reports for monitoring and reporting, with
  export to Stata for analysis. (Lab 6)

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Other Options

• Qualtrics/SurveyMonkey/REDCap survey with export
  to Stata/SAS/R/SPSS for monitoring, reporting,
  and analysis
• OnCore, SF Coordinating Center, MUSC, MediData
  Rave, Dacima, Oracle InForm, DataLabs EDC,
  OpenClinica, ...

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Not Acceptable in Epi 218

• Collect data by hand-writing on paper forms
• Transcribe into Excel tables
• Import into Stata for monitoring, reporting and
  analysis

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Hand-writing onto paper forms

• Subsequent transcription into computer introduces
  errors
• No validation checks (allows April 31)
• Branching logic can be confusing (Chapter 15
  Appendix)
• Cant use iPhone, iPad, etc.
• Occasionally, still the best option (PHTSE Study)

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Transcribing into Excel tables

• No data dictionary (meta-data)
• No automatic data validation (text in numeric
  fields)
• On-screen forms are much easier and less error
  prone
• No skip logic
• Security, auditing, and file corruption problems
• Not acceptable for Epi 218 Final Project

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Importing into Stata for monitoring and reporting

• Perfectly acceptable option
• Necessary if using REDCap and not Access or
  another tool
• Some (e.g., MAK) prefer Access query design grid
  and report-writer to Stata command lines and Do
  files

REDCap does not have a report writer and has
very limited querying capabilities.
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Access vs. REDCap (Differ in 2 dimensions)

• Installed vs. Web-based
• Relational, multi-table, SQL-based vs. flat file
• There are web-based platforms, e.g. QuesGen, that
  accommodate complex data structures

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Web-Enabled Research Platform

• Available anywhere with an internet connection
  (no terminal server)
• No software requirement beyond a browser (no
  Parallels, MS Office, etc)
• Easy to share data
• No PHI on laptops or USB drives
• Hosted (Neither you nor your departmental
  computer person administer the database server.)

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Advantages of Web-Enabled Research Platforms over
Access Databases

• User security, roles, and management
• Data security (back ups)
• Auditing data changes
• Skip logic (easier to program)
• Other survey features (automatic emailing, URLs,
  etc.)
• Built-in data quality tools
• Shared form library (REDCap)

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Getting to Shared Forms Library in REDCap

• Demonstration if time
• Note that REDCap SF-36 does not score the form

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Disadvantages of Being Web-based

• Limited look-and-feel options on forms (In
  contrast, Access forms are highly customizable.)
• Limited data structures (REDCap)
• Limited data validation (REDCap)
• Requires an internet connection

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Web-based Platforms

• REDCap (last week and this week)
• QuesGen (next week)
• Oncore (two weeks?)
• Others
• OpenClinica
• Oracle InForm

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Jargon from the Clinical Trials World

• EDC (electronic data capture)
• eCRFs (electronic case report forms)
• CDM (Clinical Data Management)
• Edit checks (validation rules)
• Queries (can mean SQL queries of data tables or
  questions to study sites to clarify data)
• AE (Adverse Event), SAE (Serious Adverse Event)
• CFR 21 Part 11 (Code of Federal Regulations,
  Chapter 21, Part 11)

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CFR 21 Part 11

• Required for submission of electronic data to the
  FDA when applying for drug or device approval
• Audit trail of all data entries, updates, and
  deletions.

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Prokscha, 3rd Edition