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REDCap Terms of Use

REDCap is a secure, web-based clinical studies management system used for building and managing the forms, surveys and underlying databases needed in health and clinical research studies. Because the REDCap system allows direct access to data, including Protected Health Information (PHI), access is allowed only for authorized users.

  • East Carolina University requires that all data collected or stored in REDCap follow the processes and procedures outlined in this document. All research studies must have IRB approval. All Quality Improvement projects must have approval from either the director, dean, or department chair.
  • If it is a research study, it must be approved by the University Institutional Review Board (IRB) before the research study can be moved to production and data collection can commence. If the research study will include other collaborative personnel such as co-investigators, technicians and students, the principal investigator must do several things: (1) the personnel must be listed on the approved IRB form (2) the PI must fill out a REDCap Project Account request form at ithelp.ecu.edu. Each project and user access must be approved prior to moving to production.
  • If data is collected for quality improvement, but still considered either sensitive, protected health information, or HIPAA information, then prior to using the system, approval from the departmental chair, dean or director is required. Each collection and user access must be approved prior to moving to production. The letter of approval must contain the project name, owner, secondary owner and collaborators. Any change to this information will require an updated approval letter.
  • It is the responsibility of the principal investigator or quality improvement collector to ensure that collaborative personnel have the appropriate study-specific, related training and have reviewed the required safeguards according to the East Carolina University policies and procedures.
  • Bi-annually, an email is sent to each REDCap user to confirm whether access is still required.If a project or collection is identified as not having an owner because the primary owner has left the university, the department head and secondary owner (if available) will be contacted to locate a new owner. The new owner must receive approval from the current department head and the new department head. If no new owner is approved, the project or collection will be removed from REDCap.
  • Users of REDCap must adhere to all ECU computer policies, regulations, rules and standards. It is the responsibility of the principal investigator and the administrator of each account to routinely monitor REDCap; however, ECU reserves the right to access any account to investigate issues that are reported or discovered to enforce applicable federal, state, University of North Carolina Board of Governors and university laws and policies.
  • In response to concerns and complaints, ECU administrators may examine accounts that are being used to conduct ECU business and use information in formal and informal disciplinary proceedings.

As the Principal Investigator:

  • I affirm that I have completed all necessary training including but not limited to Human Research Studies training (CITI) and HIPAA training required.
  • I affirm that all requested collaborators have completed all necessary training including but not limited to Human Research Studies training (CITI) and required HIPAA training.
  • I agree to safeguard my data in compliance with university policies and standards, federal regulations and state laws.
  • I agree not to release or share data except as described in my approved IRB application.
  • I agree I am solely responsible for who has access to my data.
  • I agree to monitor the activity and users who have access to my data, and I will promptly remove users who no longer need access.
  • I agree to only use the minimum necessary PHI identifiers linked to sensitive data.
  • I agree to notify REDCap administrators when the study is no longer needed in REDCap.
  • I agree that at the completion of my study: 1) I will move data to a storage area approved for sensitive data, 2) I will notify REDCap administrators to remove my data, and 3) I will contact Research and Graduate Studies to have my study archived.

As the Quality Improvement Collector:

  • I affirm that I have completed all necessary training including but not limited to required HIPAA training.
  • I affirm that all requested collaborators have completed all necessary training including but not limited to required HIPAA training.
  • I agree to safeguard my data in compliance with all applicable university policies and standards, federal regulations and state laws.
  • I agree not to release or share data except as defined and governed by all applicable university policies and standards, federal regulations and state laws.
  • I agree I am solely responsible for who has access to my data.
  • I agree to monitor the activity and users who have access to my data, and I will promptly remove users who no longer need access.
  • I agree to only use the minimum necessary PHI identifiers linked to sensitive data.
  • I agree to notify REDCap administrators when the collection is no longer needed in REDCap.
  • I agree that at the completion of my collection: 1) I will notify REDCap administrators to remove my data, 2) I will move data to a storage area approved for sensitive data.

As a Team Member:

  • I affirm that I have completed all necessary training including but not limited to Human Research Studies training (CITI) (for IRB Studies) and required HIPAA training.
  • I agree to safeguard my data in compliance with all applicable university policies and standards, federal regulations and state laws.
  • I agree not to release or share data except as described in my approved IRB application or the Quality Improvement collector.
  • I agree to follow all rules associated with the data and follow all procedures dictated by the PI of the study or the Quality Improvement collector.
  • I agree to only use the minimum necessary PHI identifiers linked to sensitive data.

Vanderbilt University Terms of Use

Grant of License

Vanderbilt is the owner of all rights, title and interest in the "Research Electronic Data Capture Software" known as REDCap, and hereby grants the Licensee, East Carolina University, and Licensee's Permitted Users to execute and use the Licensed Intellectual Property solely for the Licensee's own Non-Commercial Research Purposes and to create, or have created, Derivative Works. For the purposes of this agreement, "Non-Commercial Research Purposes" means research conducted by Licensee in a manner consistent with its tax-exempt status, and may include such research funded by commercial (for profit) organizations, but shall not include use of the Licensed Intellectual Property as the basis for providing a contract service to an entity.

Vanderbilt shall coordinate all publications related to the Licensed Intellectual Property and its methodologies, functionality, and/or abilities to support research electronic data capture. As such, Vanderbilt shall have the right to review, edit and have the Software and Consortium Members referenced on any publications created by Consortium Members which discuss the Software and it methodologies, functionality, and/or abilities.

Publications that describe scientific studies which have utilized the Licensed Intellectual Property shall reference the Software and Consortium, but neither Vanderbilt nor any other Consortium Member is not an author of the scientific student conducted utilizing the Licensed Intellectual Property shall have the right to review or edit such publications unless the authors request such assistance.

Export Controls

Licensee shall comply with all export laws and regulations of the United States and shall not export or re-export the Licensed Intellectual Property in violation of any such laws or regulations of the United States and shall not export or re-export the Software in violation of any such laws or regulations, or without all necessary approvals. Diversion of the Software contrary to U.S. law is prohibited. The parties acknowledge that neither the Software nor the underlying information or technology may be downloaded or otherwise exported or re-exported (A) into Cuba, Iran, North Korea, Sudan, Syria or any other country subject to U.S. trade sanctions applicable to the Software or (B) to anyone on (i) the U.S. Treasury Department's list of Specially Designated Nationals and Blocked Persons, (ii) the U.S. Commerce Department's Denied Persons List, Entity List or Unverified List or (iii) the Non-proliferation Sanctions List. Licensee agrees to the foregoing and represents and warrants that it complies with these conditions, is in good standing and eligible to receive the license granted hereunder, and shall continue to operate in compliance with these representations.

Use of Name

Neither Party shall use the other Party's name or any adaptation of it in any advertising, promotional or sales literature without the prior written consent of the other Party except as provided in this Agreement.

Confidentiality

Licensee shall treat such Confidential Information as confidential and use the same degree of care as it employs in the protection of its own confidential information, but in no event less than a reasonable degree of care.

Citing REDCap

Please cite the publication below in study manuscripts using REDCap for data collection and management. Use the following boilerplate language:

Study data were collected and managed using REDCap electronic data capture tools hosted at [YOUR INSTITUTION].1 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.

Paul 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.