NIH

IRB Template:

The following content may be used in your IRB application if you are planning to use REDCap:

Study data will be collected and managed using REDCap (Research Electronic Data Capture). REDCap is a secure web application designed to support data capture for research studies, providing user-friendly web-based case report forms, real-time data entry validation (e.g. for data types and range checks), audit trails and a de-identified data export mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus). The system was developed by a multi-institutional consortium which includes The Pennsylvania State University and was initiated at Vanderbilt University. The database is hosted at the Penn State Hershey Medical Center and College of Medicine data center, which will be used as a central location for data processing and management. REDCap data collection projects rely on a thorough study-specific data dictionary defined in an iterative self-documenting process by all members of the research team. This iterative development and testing process results in a well-planned data collection strategy for individual studies. REDCap is flexible enough to be used for a variety of types of research and provides an intuitive user interface for database design and data entry.

Publications / Proceedings / Presentations:

P.A. Harris, R. Thielke, R. Taylor, J. Payne, N. Gonzalez, J.G. Conde. Research Electronic Data Capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support. Journal of Biomedical Informatics, 2008


Citing REDCap:

Please cite the REDCap project and the Penn State CTSI grant when publishing manuscript using the following language:

Study data were collected and managed using REDCap electronic data capture tools hosted at the Penn State Milton S. Hershey Medical Center and College of Medicine. 1REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing:

  • an intuitive interface for validated data entry
  • audit trails for tracking data manipulation and export procedures
  • automated export procedures for seamless data downloads to common statistical packages
  • procedures for importing data from external sources

1Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81.

Please Acknowledge NIH Grant Support in each publication, press release or other documents about research that benefited from the Penn State Clinical and Translational Research Institute Clinical and Translational Science Award (CTSA) UL1 Grant and include a disclaimer such as the following:

“This publication (or project) was supported by the Penn State Clinical & Translational Research Institute, Pennsylvania State University CTSA, NIH/NCATS Grant Number UL1 TR000127 and UL1 TR002014. The contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH or NCATS.”