This page is meant to answer questions specific to the ITHS REDCap installation and its governing policies.
We recommend you review the dedicated REDCap FAQ page embedded in REDCap if you have a general question about how to accomplish certain tasks. Please note that a REDCap account is required to access those materials.
General REDCap training videos are available within REDCap itself. Please sign in to REDCap to view the videos. Note that a REDCap account is required for access.
Please view the FAQ section dedicated to user management.
People without a UW NetID can request a very limited version of the UW NetID by following the instructions below:
Before starting this process, please make sure that the user you are adding has logged into REDCap at least once before. If you try to add a user without them logging in at least once, you will effectively block this user from REDCap.
Provided you have the appropriate user rights (i.e. rights to edit user rights), you should find a link in the application list on the left hand side of the screen called “user rights”.
If this is not the case, contact someone with the appropriate rights or the REDCap Administrator.
Double check if you used the correct formatting for adding a user.
The correct format is [uwnetid]@washington.edu.
The formats [uwnetid]@uw.edu & [uwnetid]@u.washington.edu will not work correctly due to security constraints.
If you double-checked the format and the problem still exists, contact the REDCap Administrator.
REDCap sends out these verification emails automatically, so they sometimes get caught in spam filters.
Try checking your spam filter folder for the verification email. If you can’t find the verification email, contact the REDCap Administrator to remove this verification requirement. Make sure to mention which ID you are using to login.
Yes, you can possibly use any project(s) in the ITHS REDCap instance as the database part of your study in order to adhere to Part 11 compliance. However, you will need to implement the additional necessary procedures yourself in order to become fully compliant.
REDCap is 21 CFR Part 11-ready, meaning that if implemented in conjunction with appropriate procedures, documentation, and qualification, then your study may meet part 11 requirements. However, compliance depends on the setting, which includes both the technical aspects of the installation and maintenance, quality requirements [Implementation Quality (IQ) – Operational Quality (OQ) – Production Quality (PQ)], as well as the essential processes put in place by users.
To be clear, 21 CFR Part 11 compliance requires compliance on two fronts: (i) the ITHS side, which includes REDCap and (ii) the user side, which is outside the purview of the ITHS.
The ITHS has provided a secure environment for REDCap instances, which are frequently upgraded and backed up daily to a secure site. Login accounts to these instances are provided and monitored by ITHS personnel. Logins are provided to personnel of the ITHS partner institutions and organizations affiliated with the ITHS or its partner institutions.
Details about the general REDCap security features that may support Part 11 compliance can be found in the “About REDCap” document released by Vanderbilt University. In addition, ITHS procedures are in compliance with University of Washington’s Information Technology Services (ITS) security requirements and are described in the current version of “ITHS REDCap Security”. Information about ITHS practices that may support Part 11 compliance can be found in other parts of this FAQ. The ITHS policies supporting our REDCap instance can be found below.68 kBAbout REDCap (Vanderbilt)134 kBREDCap System Security Statement – 03-29-2013136 kBITHS REDCap Support Policies – 09-24-2012
On the user side, the individual user or study team is also responsible for ensuring compliance, including establishing appropriate standard operating procedures to protect and document data. Many of the activities encouraged by Part 11 are good practice in general, including explicit definition of study team roles and responsibilities, database change control and documentation, and record retention. Personnel training commensurate with responsibilities is also required.
FDA guidance on 21 CFR Part 11 compliance in the context of clinical studies is available on the FDA website, http://www.fda.gov/regulatoryinformation/guidances/. Guidance documents are searchable, and the following are suggested:
(1) Part 11, Electronic Records; Electronic Signatures – Scope and Application, published 8/2003
(2) Computerized Systems Used in Clinical Trials, published 5/2007.
Vanderbilt University had a committee evaluate the Part 11 compliance status of REDCap. A PDF (created 19-Sept-2013) of their findings published on the Vanderbilt wiki page can be found below.147 kBPart 11 Compliance Validation – REDCap Wiki
The bookmark module will allow you to set up project bookmarks, or custom links, that point to webpages that exist either inside REDCap (i.e., other REDCap projects) or outside REDCap (i.e., webpages on a different server on the web). Any user with “project design & setup” rights can add bookmarks to that particular project. The main difference between a project bookmark and a browser bookmark is that the project bookmark is linked to the project and a browser bookmark is linked to that particular browser on that particular computer.
Project bookmarks are commonly used to access custom plugins enabled in any given installation of REDCap.
You can create simple web links for navigating to those webpages, and the links will be displayed on the left-hand project menu. You may set various settings for each link, such as defining the label for how it appears on the left-hand menu, whether or not the link opens a new window/tab in your web browser, and which individual users (or Data Access Groups) within your project will be able to utilize these bookmarks.
Most REDCap users will use the normal web-based user interface to interact with their REDCap projects. However, REDCap also has the capability to support programmatic access through an API protocol (Application Programming Interface).
Once enabled, any other program with Internet access can then use the API protocol to interact with REDCap projects. API access is limited by an API token that is unique for every user/project combination and is constrained by the applicable user rights for that user in that project.
Documentation on how to use the API feature can be somewhat difficult to find. The standard API documentation can be found in any REDCap installation. For the ITHS installation, the API documentation can be found by accessing the ITHS REDCap instance, which requires an active account.
A basic introduction on how to use the REDCap API can be found by visiting a page maintained on sburns.org. Alternatively, ITHS’ Chris Nefcy has created a web page that allows people to “try out” various API calls in combination with their project without actually needing to program it themselves. This is a great way to discover what each API call type does and how you can best implement it for your specific project.
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