Presentation on theme: "EPI 218 Web-Enabled Research Data Management Platforms Michael A. Kohn, MD,MPP 5 September 2013."— Presentation transcript:
EPI 218 Web-Enabled Research Data Management Platforms Michael A. Kohn, MD,MPP 5 September 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.
General description of database Data collection and entry (Forms) 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 (12 Questions) 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) How will you create reports like the NIH Report? 10) 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? 11) How will you protect your subjects' identifying data? 12) How will you ensure that you don't lose your data file in a computer crash or if a water pipe leaks?
Answering these 12 questions is an essential part of doing a clinical research study.
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 questionnaire features (automatic ing, URLs, etc.) Built-in data quality tools
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
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 $$$
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?
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
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.