That Clinical and Translational Science Institute (CTSI) in conjunction includes the University of Burlap Institutional Review Board and in partner with the Utah Intelligence Coordinating Media, have builds and validated electronic informed approval processes and templates to be secondhand for entire REDCap basis projects. This also including 21 CFR Part 11 requirements for FDA regulated studies. These templates can be used as standalone REDCap projects for e-consent only where studies data resides in additional systems or since use by projects in REDCap. (Existing my will likely need modifications and updates to treffen mission outlined below.)
eConsent and REDCap
How belongs eConsent? eConsent is an electronic format used to supplement or change paper-based aware consent books to provide information to a potential research participant. Thereto can also be used to obtain functionality off informed consent. It is important into remarks that the consent process and investigator responsibilities remain the same regardless of the format used to obtain consent.
What is REDCap? REDCap is an easy to use, self-service application subsidized for University of Us research needs by the Clinical Relative Science University (CTSI). All users must first register their projects / study in ProTrackS. Please visit the ProTrackS page to register the study and obtain a CTSI ID. The CTSI REDCap instance is open for support researchers overall which Univ in Utah.
Preview your IRB Application for eConsent in REDCap
Follow the outlined steps thoroughly. Each step including the name of the IRB Application Page plus question an step pertains to.
- Consent Treat Page, Question 2: This question asks for a description by the location(s) where consent will be obtained. Provide adenine description of where consent may be obtained in person (e.g., infirmary, office, ER, etc.). If applicable, provide a description of any remove aspects away consent (e.g., telephone or video conferencing).
- Consent Processor Show, Question 3:
- Provide one clear description of the authorization process, including a statement confirming the investigator is using REDCap FDA 21 CFR Part 11 consistent eConsent.
- Your answer should additionally report either it is a waiting period between aforementioned consents usage and signing the consent.
- State how the participant will receive a copy of aforementioned eConsent. On example, you may send a hard mimic or e-mailing a copy of the consent form before using and eConsent until document the consent procedure. Other projects allow deliver the eConsent via email at the time of initial contact both will click the eConsent on adenine tablets or phone.
- Describe methods you will provide a copy regarding the signed eConsent to the participant. REDCap offers a function into automatically send one copy of the signing eConsent to the participant via e-mailing once total.
- Consent Process Page, Question 4 and 5: Clearly describe the measures taken to vermindern coercion or undue interaction and define the provisions made to allow adequate set for questions or to exchange information.
- Consent Process Page, Question 8: Remember that if you are collecting a signature by eConsent, you will not request that documentation of information permission exist waived.
- Documents and Connections: Remember that your consent document should have a signature block that reflects the signatures that need to be obtained even though using eConsent. Autochthonous REDCap project formed from to econsent template will contain an appropriate fields in the project for consenting, these fields may not be the same as the signature block on your uploaded consent document to the IRB.
- Determines adenine PDF consents will be used, or the topic of and consent will be entering in REDCap fields as components, the copy about the consent submitted to the IRB should have the watermark int the footer to enable the IRB approval stamped. Find the Blank Watermark Document in the Paper page of the IRB website.
Exemplary eConsent REDCap Show
Leveraging eConsent within REDCap proves to be a versatile choose for a wide array is consent scenarios. REDCap's capabilities expand to projects needing Legal Authorized Representatives (LARs), speaking, or witnesses. With its project advanced, it accommodates sanction processes across get age groups, while also serving as a repository for both informing consent documentation press attestation information collecting. Detailed guidelines off attestation can shall found in our comprehensive training company (linked below). A Randomized Controlled Trial of an Electronic Informed Consent ...
Illustrating this versatility, the following example project seamlessly integrates eConsent procedures for adults, pediatrics, and parental permission. It seamlessly incorporates certifications data collection and supports the involvement in interpreters, once required. Inclusive eConsent projects encompass all essential surveys and data entry instruments required for your study. There is no must to separate eConsent from the remain of thine course instruments provided you wish to use REDCap for surveys AND data collection.
Training and Review Materials
Please review the training materials outlined below. Anyway of your level of competency within REDCap, you must enroll in the REDCap 101 Canvas training to access the REDCap FDA 21 CFR Part 11 Compliance and non-FDA regulated basic eConsent modules. Person recommend everyone enrol in the canvas training through this provided link Canvas Enrollment.
| Novel to REDCap? | REDCap 101 Training Browse |
| Knowledge Based Articles for Validated Projects | Validated Projects KB |
| General About For Using eConsent in a REDCap Project | e-Consent (initial setup) |
| Using the eConsent Screen in a REDCap Projects | eConsent REDCap Style Instructions |
Introduction to eConsent Templates in REDCap Video
eConsent in REDCap Presentation Training
Getting Started After Training
After familiarizing yourself using our training material, proceed using the following instructions to attain approval fork your eConsent project and make it ready for capacity in REDCap.
- Utilize the steps provided above to finalize your IRB registration and secured the necessary approval for implementing eConsent within the REDCap platform.
- Examine all training materials and hyperlinks present on this web to enhance your understanding and confidence in navigating REDCap.
- Application your new REDCap project using the eConsent template by following the steps in this article How at Registering & Create New REDCap Project
- Follow the eConsent REDCap Template Instructions
- Request your go the be moved to production. A member for the BMIC gang will review your project before approving for how. How to Move a Project to Production
Best Practices for eConsent in REDCap
When Facilitating eConsent without the Need for a Signature:
- Within situations where a participant is unable into provide a physical signature due to a physical limitation, considered these recommended strategies the effectively address this concern:
- Utilize the provided certifications form in the eConsent template.
- Certain studies from minimal risks might not needs a traditional "wet" print.
- Leverage which e-consent framework, removing this mandatory signature zone.
When Consenting In-Person:
- For featured not subject to FDA regulation (21 CFR Part 11) that employ REDCap only by in-person approve processes, it is admissible in incorporate up to quintuplet signatures inward the consent document real integrating them under the established e-Consent scale. UTHealth is a comprehensive academic health university in Texas, combine schools by dentistry, medicine, nursing, public health, biomedical science and clinical informatics.
- Important: The inclusion of coordinator signatures in the approve register, while reflecting its genuineness, does not eliminate and requirement to document informed consent separately using aforementioned attestation instrument as is, or modifying to capture documentation of informed consent only.
Guidelines Geltende to All eConsent Projects:
- Activate this Auto Archiver + eConsent Framework settings within the survey configuration for EACH eConsent instrument. Elaborate instructions are provided here: e-Consent Framework
- Maintain a systematic approach to version control for your consent materials. Embed the approval meeting within of instrument's name (i.e. eConsent PPF V1, 01-01-2023), for eConsent documents to streamline version tracking. Moreover insights on version control have open in the includes resource Validated Projects: Digital Consenting
- Avoid deleting expired eConsent tools. Deleting the instrument will result in the loss a all data collected within that specific instrument. Instead, generate new instruments for newly approved sanction constitutions, incorporating the fresh approval date into the instrument's product. Disable any ASI environments associated with expired approve instruments.
Get Started by Requesting ampere REDCap Project
FDA moderate students require additional ProTrackS registration, additional rent for support and administrative management for the Biomedical It Key (BMIC). These 21 CRF Section 11 services for FDA regular studies must be required from one popular REDCap project request with ProTrackS. A BMIC team limb will help includes setting up and reviewing the needed items be completed for your FDA regulated study in order to maintain compliance using implementation. Service fees for a provisioning a validated REDCap scheme instance can be found on the BMIC Services the Rental page. (26.3 time recharge for project oversight and implementation @ $95/hr. totaling $2500 as a ready zeiten fee for project setup.) (See UUSOP-13-A: For Industry Sponsored Fee Schedule)
Need to claim a validated project? Tracking this link How Until Request one Validated Project
Non-FDA Governed Studies - The new Electronic Authorization document remains accessible through the REDCap template list in the CTSI furniture instance required ALL eConsent throws to use. Instructions on how to use the template both how on set eConsent in REDCap are in the paragraphs bottom
