Boilerplate language for inclusion in grants and IRB documentation

 

Grant Acknowledgement:
Please note that any publication that results from a project utilizing REDCap should cite grant support (Supported by Clinical and Translational Science Award (CTSA) Grant [UL1 TR000448] and Siteman Comprehensive Cancer Center and NCI Cancer Center Support Grant P30 CA091842).

Examples of Text for inclusion into submissions:

Example 1: (more for general citation)

The Division of Biostatistics will be used as a central location for data processing and management. Washington University, belongs to a consortium of institutional partners that work to maintain a software toolset and workflow methodology for electronic collection and management of research and clinical trial data. REDCap (Research Electronic Data Capture) 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 with planning assistance from the Division of Biostatistics. The iterative development and testing process results in a well-planned data collection strategy for individual studies. REDCap also contains a Survey tool for building and managing online surveys. The research team can create and design surveys in a web browser and engage potential respondents using a variety of notification methods. Both REDCap and REDCap Survey systems provide secure, web-based applications that are flexible enough to be used for a variety of types of research, provide an intuitive interface for users to enter data and have real time validation rules (with automated data type and range checks) at the time of entry. These systems offer easy data manipulation with audit trails and reporting for reporting, monitoring and querying patient records, and an automated export mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus).

Example 2: (more for IRB, need to update stats accordingly)
The Division of Biostatistics Informatics Core will be used as a central location for data processing and management. Washington University, belongs to a consortium of institutional partners that work to maintain a software toolset and workflow methodology for electronic collection and management of research and clinical trial data. REDCap (Research Electronic Data Capture) 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 with planning assistance from the Division of Biostatistics Informatics Core. The iterative development and testing process results in a well-planned data collection strategy for individual studies. REDCap servers are securely housed in an on-site limited access data center managed by the Division of Biostatistics at Washington University. All web-based information transmission is encrypted. The data is all stored on a private, firewall protected network. All users are given individual user ids and passwords and their access is restricted on a role-specific basis. REDCap was developed specifically around HIPAA-Security guidelines and is implemented and maintained according to Washington University guidelines. REDCap currently supports > 500 academic/non-profit consortium partners on six continents and 38,800 research end-users [1].

Example 3: (more for general citation)
Study data were collected and managed using REDCap electronic data capture tools hosted in the Biostatistics Division of Washington University School of Medicine. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) 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.
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 (doi:10.1016/j.jbi.2008.08.010).

P.A. Harris, R. Taylor, R. Thielke, J. Lee, R. Sanders, M. Isozaki, H. Howard, S. Hemphill, C. McGraw, B. Nieves, A. Peshansky, A. Nida, M. Lin. The REDCap Consortium Project: A Case Study in Collaborative Software Development for Clinical Research Informatics. (Panel Presentation – AMIA Spring Conference, 2008)

P. Harris, R. Thielke, R. Schuff, J. Obeid, M. Oium. The REDCap consortium – A case study in translational research informatics resource sharing among academic institutions. (AMIA Spring Conference, 2007)

P.A. Harris. REDCap (Research Electronic Data CAPture) project progress report for informatics resource sharing / collaboration at ten academic institutions. (Clinical Research, 2007)

P.A. Harris, N. Gonzalez, M Silva-Ramos, J.G. Conde. Web-based data collection – collaborative development of metadata collection and export modules. (Clinical Research, 2006)

P.A. Harris, J.D. Payne. Creating custom web-based data collection systems. (Clinical Research, 2005) (Abstract)
The following is an overview of our REDCap installation.

Our REDCap database is hosted on a Unix servers on our divisions secure computer network. User access is provided via an external secure web server.  All web communication between the user web browser and the web server is SSL encrypted. The database server itself is currently not encrypted via any encryption at rest schema. Further protections are provided via strict Unix permission configurations on the servers themselves.

The database is incrementally backed-up nightly, with baseline snapshots taken at the beginning of each month.  Daily incremental backups are stored for approximately 30 days, and the baseline snapshots are currently store indefinitely.  Uploaded files are stored on a secure Unix file servers and are protected by our off-site backup server.

Access to the data username/password keys is restricted in accordance with our University’s HIPAA policy.

 

SCC Biostatistics Core Acknowledgement Statement

It is very important to the continued funding of the Siteman Comprehensive Cancer Center that the productive collaboration of its cores is acknowledged in publications and presentations.  This aids in measuring our productivity and provides documentation of the scope of our services.

In addition, all publications using the services of the Biostatistics Core should contain one of the following acknowledgements:

“The authors wish to acknowledge the support of the Biostatistics Core, Siteman Comprehensive Cancer Center and NCI Cancer Center Support Grant P30 CA091842 .”

“The authors wish to acknowledge the support of the Biostatistics Core and NCI Cancer Center Support Grant P30 CA091842, Siteman Comprehensive Cancer Center,  for supporting the REDCap clinical data capture service as a research resource at WUSM

ICTS Member Publication Acknowledgement Instructions.
NIH Funding Acknowledgement

Use of any ICTS Core or service requires the following NIH Funding Acknowledgement for all publications and projects.

“Research reported in this publication was supported by the Washington University Institute of Clinical and Translational Sciences grant UL1 TR000448 from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official view of the NIH.”
ICTS Scholars and Trainees, please note:

ICTS grant supported scholars and trainees should reference the applicable NIH sub award number noted below for their direct career development/training support.

KL2 TR000450 – ICTS Multidisciplinary Clinical Research Career Development Program TL1 TR000449 – ICTS Clinical Research Predoctoral Training Program
Questions can be directed to icts@dom.wustl.edu or 314-362-9829.

Information on the National Center for Advancing Translational Sciences (NCATS) is available at http://www.ncats.nih.gov/. Information about the Clinical and Translational Science Awards program can be found at http://www.ncats.nih.gov/research/cts/cts.html.

Publication Requirements Applicable clinical trials must be registered with ClinicalTrails.gov. (http://www.clinicaltrials.gov/)

PubMed Central ID (PMCID)

NIH-funded investigators are required to submit (or have submitted for them) their final, peer-reviewed manuscript to PubMed Central (PMC) upon acceptance of publication to be made publicly available within 12 months of publication. This policy applies to NIH-funded manuscripts accepted for publication on or after April 7, 2008. Note: PMCID is not the same as PMID.

See the WU Benard Becker Medical Library website for complete instructions: https://becker.wustl.edu/classes-consulting/specialized-expertise/nih-public-access-policy.