1. Web-Based, Hosted Research Data Management Platforms 2/12/2008

2. Outline General Comments SurveyMonkey DigMet SIMS/WATCH Carolyn Jasik Assignment 4 Course Evaluation

3. Web-based Data Collection Platforms Vendor Hosted –SurveyMonkey –DigMet and QuesGen –Medrio Not Vendor Hosted –Velos –LabMatrix –RedCap Not Discussed Here –Phase Forward –Oracle Clinical

4. Advantages of Being Web-Based Available anywhere with an internet connection No software requirement beyond a browser Easy to share data

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

6. Advantages of Being Hosted No need for servers, system administrators, etc.

7. Disadvantages of Being Hosted Patient confidentiality/HIPAA issues Auditing (CFR 21 Part 11– Electronic record- keeping requirements of the FDA) (Except for SurveyMonkey, the web-based data collection systems CLAIM to handle these issues and requirements) (Access databases can meet patient confidentiality requirements but not CFR 21 Part 11)

8. SurveyMonkey Demo

10. Enter Helen’s exam Show SF-36 (Time Permitting)

11. SurveyMonkey Advantages Beautiful forms Simple to create Hosted Inexpensive Great for surveys

12. SurveyMonkey Disadvantages Market-research oriented, not medical Flat file No audit trail Limited user roles, security Not designed for PHI/HIPAA compliance Limited skip logic

13. Digmet Demo

15. Set up database and enter Robert’s data Show populated database Data extract (time permitting)

16. Advantages of Digmet Multiple user roles (DB admin, team member, view-only) PHI fields explicitly identified (masked from user without PHI privileges) UCSF IT reviewed Easy to add/change/format fields Templates for clinical research (medication, lab sample, etc) and systematic reviews (publication) Inexpensive (1 st month free), but still under development

17. Disadvantages of Digmet Still has some bugs and unimplemented features Same as other web-based platforms –Limited look-and-feel options –Limited data structures (but not flat file like SurveyMonkey) –Requires network connection

18. SIMS/WATCH Carolyn Jasik

19. Assignment 4 Due 2/19/08, send to ucsfdbclass@yahoo.com Write a one-page data management section for your research study protocol or a one-page description of your current research study database. At the beginning of your assignment, for the readers, briefly describe your study, including design, predictors, outcomes, target population, and sample size. (1 or 2 sentences). Optionally, include with your assignment a relationships diagram* showing the structure of your study database. The elements of a data management protocol or database description were covered in the 2/5/08 lecture and include: General description of database (possibly including a relationships diagram*) Data collection and entry Error checking and data validation Analysis/Reporting (e.g., export to Stata) Security/confidentiality Administration/Back up Extra Credit: Include a budget or cost estimate for data management. *Relationships diagram is optional

20. Assignment 4 1) What is your study? ("The [CUTE ACRONYM] study is a [DESIGN] study of the associations between [PREDICTOR] and [OUTCOME] in [STUDY POPULATION]"). 2) What data points are you collecting? (Helps to have an actual data collection form mocked up in Word or Access.) 3) Who will collect the data? You? RAs? MDs? Maybe the study subjects will enter the data themselves.

21. Assignment 4 (cont’d) 4) How will the data be collected? Written onto a paper form and then transcribed into a computer file? Entered directly into the computer? (If it's going to be transcribed, will you be doing that? Will you hire somebody? Or will you enlist some med students?) 5) Will the above-mentioned computer file be an Excel file, Stata file, Access file, or something else? 6) If it's a single table database (e.g., Excel or Stata), what will the rows represent, what will the columns be? Try to provide a detailed data dictionary with the name, data type, description, and validation rules for each field (column) in the single table.

22. Assignment 4 7) If it's a multi-table database, even a hand-drawn relationships diagram would help but is not required. 8) How will 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 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?

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