1. EPI 218 Web-Enabled Research Data Management Platforms Michael A. Kohn, MD,MPP 30 August 2012

2. Final Project: Part A Send in or Demonstrate Your Study Database Due 9/20/2012 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.

3. 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. Final Project: Part A Send in or Demonstrate Your Study Database Due 9/20/2012

4. Original Data Collection Forms NHAMCS 2004 NHAMCS 2005 Pletcher, M.J., et al., Trends in opioid prescribing by race/ethnicity for patients seeking care in US emergency departments. Jama, 2008. 299(1): p. 70-8.

5. General description of database Data collection and entry Error checking and data validation Analysis (e.g., export to Stata) Security/confidentiality Back up Final Project: Part B Submit Your Data Management Plan Due 9/20/2012

6. Final Project Due 9/20/2012 Start thinking about this now. Build your own study database as you work through the labs. Use extra time in lab to work on your study database. Set up appointments with course faculty early.

7. 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?

8. 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, Medidate 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).

9. 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?

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

11. Loose Ends: When is yes/no field useful? All-that-apply questions Check lists (e.g. forms that need to be filled out)

12. Loose Ends: Parental Education Access database QuesGen database

13. 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)

14. 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.

15. Web-based Platforms REDCap (last week) QuesGen (this week) Medidata RAVE (next week) Others OpenClinica Oracle InForm Oncore

16. 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.)

17. 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 questionnaire features (automatic emailing, URLs, etc.) Built-in data quality tools

18. Disadvantages of Being Web- based Limited look-and-feel options on forms (In contrast, Access forms are highly customizable.) Limited data structures (REDCap) Requires an internet connection

19. Advanced Capabilities of Infant Jaundice MS Access Database* Displayed on subject form Any number of exams Any number of medications Any number of lab results (bilirubin trajectory, direct antiglobulin, etc) Detailed information on examiners Table lookups to calculate z-scores and percentiles for weight, height and BMI Sophisticated conversion of trade names to generic drugs * Generally would require the assistance of an Access developer $$$

20. Web-enabled Databases REDCap – No advanced capabilities QuesGen – Can do almost anything the Access database can do, but may be more expensive (Access developer vs. QuesGen developer) MediData RAVE, OpenClinica, Oncore, etc – Who knows?

21. QuesGen Demo Delete and restore Helen’s record* Run the NIH Report Dashboard AvgScore Data Dictionary Use Jif database in studydata.net. * Auditing is one place where REDCap and QuesGen are much better than Access

22. Comparison REDCap vs. QuesGen Posted on course website If you don’t have a budget and you can’t use Access, you should use REDCap.

23. Questionnaires: Branching Logic Paper Access REDCap QuesGen

25. Access SkipLogicExample.mdb

26. REDCap SmokingHx

27. QuesGen JIF Smoke example

28. SurveyMonkey