Web-Based, Hosted Research Data Management Platforms

2/12/2008

Outline

• General Comments

• SurveyMonkey

• DigMet

• SIMS/WATCH Carolyn Jasik

• Assignment 4

• Course Evaluation

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

Advantages of Being Web-Based

• Available anywhere with an internet connection

• No software requirement beyond a browser

• Easy to share data

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

Advantages of Being Hosted

• No need for servers, system administrators, etc.

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)

SurveyMonkey Demo

SurveyMonkey Demo

• Enter Helen’s exam

• Show SF-36 (Time Permitting)

SurveyMonkey Advantages

• Beautiful forms

• Simple to create

• Hosted

• Inexpensive

• Great for surveys

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

Digmet Demo

Digmet Demo

Set up database and enter Robert’s data

Show populated database

Data extract (time permitting)

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 (1st month free), but still under development

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

SIMS/WATCH

Carolyn Jasik

Assignment 4Due 2/19/08, send to ucsfdbclass@yahoo.comWrite 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 entryError checking and data validationAnalysis/Reporting (e.g., export to Stata)Security/confidentialityAdministration/Back upExtra Credit: Include a budget or cost estimate for data management.

*Relationships diagram is optional

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.

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.

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?

Answering these questions is an essential part of doing a clinical

research study.