EPI 218 Web-Enabled Research Data Management Platforms Michael A. Kohn, MD,MPP 29 August 2013

Final Project: Part A Send in or Demonstrate Your Study Database Due 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 , you can send us a link or work out another way to review your database.

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 ing the author of the original study. Final Project: Part A Send in or Demonstrate Your Study Database Due 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 Final Project: Part B Submit Your Data Management Plan Due 9/18/2013

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?

Final Project (cont’d) 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).

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?

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

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)

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,...

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

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) Can’t use iPhone, iPad, etc. Occasionally, still the best option (PHTSE Study)

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

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.

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

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.)

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 ing, URLs, etc.) Built-in data quality tools Shared form library (REDCap)

Getting to Shared Forms Library in REDCap Demonstration if time Note that REDCap SF-36 does not score the form

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

Web-based Platforms REDCap (last week and this week) QuesGen (next week) Oncore (two weeks?) Others OpenClinica Oracle InForm

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)

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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