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Clinical Database and Survey Management Tool

The University of Kansas Center for Research Methods & Data Analysis (CRMDA) together with the Information and Telecommunication Technology Center (ITTC) offer REDCap as a comprehensive solution for data capture and storage needs.  REDCap is a secure, web-based clinical research data capture and storage application developed by a consortium between Vanderbilt University, the NIH, and nearly 1000 participating international research institutions, including KU.  REDCap resides on HIPAA compliant servers maintained by KU ITTC and certified by KU Information Security.   The CRMDA provides application support while ITTC ensures your data is safe and secure.  This secure web-based system allows data to be validated upon entry into standardized formats compliant with NIH reporting.

Advantages of REDCap as your research data capture system:

  1. Highest level security assurances for data entry, storage, and archiving on HIPAA compliant servers
  2. Automated export procedures for seamless downloads of de-identified clinical data to common statistical packages (SPSS, SAS, Stata, R)
  3. Robust user rights control access to confidential or identifying variables
  4. Clinical report creation and data quality checks at participant- and study-level
  5. Audit trails for tracking the development of study protocols, amendments, data manipulation, and exports
  6. Web-based collection through data entry, bulk import, or surveys; or export forms to pdf for paper copies
  7. Intuitive interface for database/survey creation along with access to the REDCap Shared Library allows for rapid project development
  8. Branching logic and calculated fields to aid in real time participant screening and enrolling criteria
  9. Integrated scheduling and automated survey invitations through email for efficient clinical follow up
  10. Dynamic Data Pulls (DDP) for the direct importing of medical records or a similar database structure to a REDCap project
  11. Advanced API support allows for secure downloads to active statistical programs - data never needs to be written to disk outside the secure server

REDCap Fee Structure

REDCap access is a service for which the CRMDA recovers its cost by following an approved rate structure.  The standard fee for REDCap access is $2290 for a 3 year research project.  Additional years of access and storage are available.

The basic rate includes only a minimal amount of project support--just enough to get the researcher "up and running." We offer additional assistance in the planning and development of survey instruments on a fee-for-service basis. The hourly labor charge for that support is charged at the standard CRMDA rate.

To request a REDCap User ID

PIs and team members need to have REDCap accounts.  Each individual (REDCap PI or assistant) who intends to log in on REDCap must complete the  Redcap ID Request Form ».

After accounts are created, then the REDCap project PI uses tools inside REDCap to welcome team members into each project and assign rights.  The REDCap framework puts the responsibility for project management on the Principal Investigator.  The PI has the duty to make sure that the pieces of information that need to be secured are properly protected.  The Principal Investigator has the right to designate other research team members who can design surveys, import and export information. 

REDCap Roles: The Difference between PI and REDCap PI

Some research projects are so large that the principal investigator is too busy to manage details in REDCap. In cases like that, another team member will be designated as the as the REDCap Principal Investigator (REDCap PI).  This is necessary because, for every project, CRMDA staff needs to know which team member is the primary point of contact. When new projects are created, we will ask for the name and email address of the REDCap PI.

To Create a REDCap Project

REDCap principal Investigators may contact the CRMDA's REDCap administrator to discuss the suitability of REDCap for a given research project. To initiate a REDCap project, it is necessary to complete the form to initiate a new REDCap Project Survey.

CAUTION: Please be aware of the following technical limitation of the REDCap framework:

Our REDCap server is designed to handle projects with no more than 15,000 records.  If a project is allowed to grow significantly beyond that size, the server becomes slow/unstable during some phases of data retrieval. We have asked all existing project to take this into account and we insist that all new projects take this into account when surveys are designed.  We have some experience advising teams that need to split projects into segments or otherwise re-organize data in order to remain under the 15,000 record limit.

 

Freecap - Learning, Development, and Testing

FREECap is a REDCap system that is not HIPAA compliant: Do not upload secure data to this system.

Many faculty members and graduate students want to give REDCap a try, but they do not yet have a funded research project that would afford access to the secure REDCap environment.  The CRMDA staff needed a "practice server" for that same purpose and we have decided to open the doors and welcome all members of the KU community.  Our alternative server, FREECap, is managed by CRMDA staffers. It runs the regular REDCap software, the only difference is the hardware.  This server is not in the secure vault; we do not have precautions in place required to safeguard the server that would be required for a true HIPAA compliant server.  This is the system that we use for workshops and other instructional seminars.

We regularly update the REDCap software on this server and the user experience will generally be the "latest and greatest" that REDCap has to offer.  This is a great way to get familiar with the REDCap interface instead of having to learn it under pressure in a project with hard deadlines.

We encourage KU affiliates to use this for teaching, practice, and testing.  This server is perfect for research that doesn't need to be HIPAA compliant.  Please note that the CRMDA cannot offer unpaid technical support for projects hosted on this server; however, we do offer limited FREECap and REDCap support via our Open Consulting structure.  Please see the consulting page for more information.

Links:

  1. Request a FREECap Account Fill out a form, we approve all requests by people that have KU login accounts.
  2. Go to the FREECap login page

 


Human Subject / HIPAA Compliance Training

The level of formal Human Subjects / HIPPA compliance training is left to the discretion of the PI.  However, formal training for how to handle sensitive data is strongly recommended.

Human Subjects Training at the University of Kansas is provided through the Collaborative Institutional Training Initiative (CITI).  The links below will take you to KU's instructions for completing the training and the official CITI site.

KU HIPPA and HIPS

CITI

For any other general questions regarding KU Human Subjects compliance policies visit thier site here.

For More Information Please Contact:

REDCap Administration
The University of Kansas
Center for Research Methods and Data Analysis
1425 Jayhawk Blvd.
Lawrence, KS 66045 -7556
E-mail: redcap_admin@ku.edu

 


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