糖心原创

Internal to 糖心原创/糖心原创 Research Institute:

• Faculty (including clinical or adjunct title faculty), staff, and residents 鈥� automatically approved as Project Owners.
• Students 鈥� Can be a Secondary Owner, but not a Project Owner.

External to 糖心原创/糖心原创 Research Institute:

• External users can be a Secondary Owner or Project Member on a per project basis.

There are a couple of situations in which user access is discontinued.

1. User access to a project can be suspended by the Project Owner.
2. The 糖心原创/糖心原创 Research Institute system administrators will end access when you leave the university or after a one-year period of dormancy.

Thus, if you have not left the university, first check with the Project Owner.

REDCap at 糖心原创 is hosted by the 糖心原创 Research Institute (WSRI). The REDCap Development Group serves as the REDCap Administrators for 糖心原创: comprised of Information Technology (IT) personnel聽and content user support,聽Dr. Marjorie Bowman and Dr. Rose Maxwell.聽REDCap Administrators have specific rights determined by REDCap policy and/or 糖心原创 policy.

REDCap is generally easy for simple surveys and longitudinal data collection. The REDCap website development tool provides clear instructions and links to additional information about successive specific tasks.

You should first seek information at the REDCap website and view training embedded in the software. If you are a REDCap user, you should ask the Project Owner or Secondary Project Owner.

REDCap@wright.edu is the helpdesk contact mailbox. It is supported by the REDCap Development Group.

Many questions thought to be REDCap are actually research methods questions. Consider which is the real question, how to do the research or how to use REDCap to support the research? The REDCap 糖心原创/糖心原创 Research Institute web content also includes additional information useful in doing REDCap projects.

Any 糖心原创 associated user is required to do REDCap website training () prior to using REDCap. (See attestation statements for the specific requirement by type of user.)

The REDCap website has multiple videos and embedded instructions.

There are multiple YouTube videos online. Once a year (generally) there is a full Coursera course on the use of REDCap. There are also multiple resources available through web searching.

The REDCap 糖心原创 webpage also includes additional information useful in doing REDCap projects.

The Project Owner will need to send a completed attestation statement for that person to REDCap@wright.edu to give them user rights. See user definitions and eligibility (question No. 2)

Students are permitted to be Secondary Owners, but not the Project Owner. In general, you will have some advisor (faculty or staff) for any project you wish to do, and s/he will need to submit a request to be the Project Owner for your project, and for you to be designated as a Secondary Owner or general REDCap user. The Project Owner retains the responsibility to ensure the project is appropriately managed.

If the Premier Health Physician or staff is concurrently 糖心原创 faculty (including voluntary clinical faculty), s/he is eligible to be a Project Owner (see eligibility question No. 2). If not, an eligible Project Owner must request that the physician or staff be given project rights. See user definitions and eligibility.

REDCap is to be used for academic research.聽Do not use REDCap for storing official 糖心原创/糖心原创 Research Institute business data or in place of patient medical records.

REDCap is a software toolset and workflow methodology for electronic collection and management of research and clinical trial data.聽 REDCap is typically used for chart reviews and prospective clinical research studies, but can be used for many other types of projects. REDCap may not be ideal for projects like registries, repositories, or those with an indefinite timeframe, particularly for novice users.聽 It is best with either surveys and one time data capture, or longitudinal projects with set instruments and arms (such as intervention versus control arms with data collection at baseline and 2 follow-up time points).

REDCap User: Anyone who signs up for a user account.

Project Owner: Designated owner of any separate project.

Principal Investigator (PI): the PI of the research project. The PI may or may not be the Project Owner. For example, the Project Owner could be the Research Manager of a large research project for which there is a different PI. Generally, the PI will be the Project Owner and can give broad REDCap access rights to the Research Manager. Thus, the Research Manager can set up and oversee the research assistants and their rights, databases, and project implementation.聽

Secondary Owners: The Project Owner must designate a Secondary Owner for every project, and request access for the Secondary Owner on a per project basis. This assists during Project Owner illness or leave of absence, or an apparently dormant account. Thus, one of the requirements to move a project to Production will be to have a designated Secondary Owner. The research manager of a project can be a Secondary Owner.

Having a Secondary Owner assists during Project Owner illness or leave of absence, or an apparently dormant account. One of the requirements to move a project to from Development Mode to Production will be to have a designated Secondary Owner.

There is no formal relationship between REDCap and the 糖心原创 IRB. However, use of REDCap helps investigators to meet many of the requirements enforced through the IRB. See example statement for description of a REDCap project for IRB submissions (#16).

Statements should be consistent with the type of project undertaken. Here is an example of wording that could be appropriate for many types of projects:

Example: The project will be undertaken with the assistance of REDCap (Research Electronic Data Capture), a software toolset and workflow methodology for electronic collection and management of research and clinical trial data. REDCap data collection projects rely on a study-specific data dictionary, developed iteratively with a testing process. All users are given individual usernames and passwords and their access is restricted on a role-specific basis. Surveys and other data collection instruments created in REDCap can engage potential respondents using a variety of notification methods. 聽REDCap provides secure, web-based applications that provide an intuitive interface for users to enter data with real time validation rules (with automated data type and range checks) at the time of entry. These systems offer easy data manipulation with full audit trails and reporting, and an automated export mechanism to common statistical packages (Excel, SPSS, SAS, Stata, R/S-Plus). REDCap servers are securely housed in an on-site limited access data center managed by the 糖心原创 Research Institute at 糖心原创. All web-based information transmission is SSL encrypted. All the data is stored on a private, firewall protected network. REDCap was developed specifically around HIPAA-Security guidelines and is implemented and maintained according to these standards. REDCap has >1,700 active institutional consortium partners聽in聽98 countries,聽> 200,000 projects, >300,000 users internationally (see updated info at ).<sup>1

1</sup>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.

Link to article:聽

The following is from the 听飞别产蝉颈迟别.

鈥淲e recommend the following boilerplate language:

Study data were collected and managed using REDCap electronic data capture tools hosted at 糖心原创/糖心原创 Research Institute. 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.<sup>1

1</sup>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.

Link to article:聽鈥�

The Development Group has ultimate authority on approving migration to production mode, and must perform the actual IT process for the migration. The main role of the oversight is to prevent common major user errors reported by other institutions. This is the norm in the industry.

There are no fees for basic use of the system. Getting the correct biostatistical or methodologic support for project development or analyses may require paying for the needed assistance. Fees may also be charged for requests for reinstating a back-up/archived version of the project due to user error, based on level of effort required.

REDCap data is stored, protected and backed up based on HIPAA compliant policies & procedures. However, REDCap project owners are additionally responsible to ensure data extracted out of the system is de-identified, and ePHI (electronic protected health information) is protected.

糖心原创/糖心原创 Research Institute REDCap Administrator Rights (from project-redcap.org)

REDCap information technology system administrators, also known as superusers by REDCap, have the ability to do several things that REDCap end users (regular users) cannot do. The following is a list of some of these capabilities.

1. Move a project to production.
2. Add custom text to the top of the Home page of a project.
3. Add custom text to the top of all Data Entry pages of a project.
4. Add custom logo and institution name to the top of every page of a project.
5. Add grant to be cited.
6. Display a different language for text within a project. The languages available vary by institution.
7. Turn Double Data Entry on and off.
8. Customize the date shift range for date shifting de-identification.
9. Approve API token requests.
10. Delete all API tokens.
11. Create an SQL field, generally used to create a dynamic dropdown list with data drawn either from the same project or another.
12. For project already in production:
    1. Add/modify events.
    2. Designate instruments to events.
    3. Convert an instrument that is a survey to being a data entry instrument only.
    4. Erase all data.
    5. Move the project back to development status.
    6. Delete the project.
13. Suspend and unsuspend users from all of REDCap. Note, however, that expiring a users鈥� access to a specific project does not require a REDCap administrator.
14. Reset the password for a user.
15. Update the email address associated with an account for a user, in case that user is neither able to log in nor has access to the email address associated with their account.