REDCap eConsent in Clinical Research: Best Practices for UAE CROs and Hospital Research Units

Paper consent fails in predictable ways: missing signatures or dates, an outdated form version, and copies that are hard to retrieve when a monitor asks. It also makes remote recruitment slow. Reviews of electronic informed consent in clinical research report better completeness, easier version control and support for remote participation, with digital literacy and regulatory uncertainty as the main obstacles [1, 2].

REDCap eConsent is attractive because many hospitals already run REDCap for data capture [3]. If your study database is being built at the same time, our REDCap database build guide for UAE clinical trials covers the data side; this article covers consent.

REDCap’s e-Consent Framework turns a survey into a consent form with a signature, a certification step and an archived PDF [4]. Switching it on does not create a compliant consent process by itself. Table 1 separates what the software does from what your protocol must decide.

1. Write for the participant first. Build the consent text from the ethics-approved document, split into short descriptive fields; long blocks can break the PDF footer [4].
2. Lock completed forms. Turn off “allow respondents to return and modify completed responses”, so changes go through the study team [4].
3. Version every form. Set the e-Consent version, and change it whenever the approved form changes, so each PDF shows which version was signed [4].
4. Verify identity before consent. Choose a method and record it per participant: identity check at the site, a one-time code to a registered phone, or a video call for remote consent [1, 6].
5. Keep the conversation. eConsent replaces the paper, not the discussion. Record how participants could ask questions and who answered [6, 9].
6. Control access. Restrict File Repository and export rights to the roles that need identified consent PDFs.
7. Test end to end. Sign test consents on phone, tablet and desktop, in each language, and check the archived PDF and audit log.

ICH E6(R3), the current Good Clinical Practice guideline, allows consent to be obtained and documented electronically, and expects computerised systems to be validated and access to be controlled and attributable [5]. For studies under US FDA oversight, the FDA and OHRP guidance on electronic informed consent sets expectations for identity, comprehension and electronic signatures [6].

Whether a REDCap signature meets these expectations depends on how the hosting institution has installed, validated and documented its REDCap instance, and on your procedures. Ask your REDCap administrator for the validation documentation before you tell a sponsor the process is compliant.

Consent PDFs contain identifiable health data. Under Federal Law No. 2 of 2019 on the use of ICT in health fields, health data is generally to be stored and processed inside the UAE; Ministerial Resolution No. 51 of 2021 sets out exceptions, including scientific research under conditions such as consent [7, 8]. An institutional REDCap instance hosted in the UAE is usually the simpler route.

Your research ethics committee must approve electronic consent, the signature method and the bilingual forms. Emirate-level health authorities and sponsors may add their own requirements, so confirm them before you build.

• Digital literacy and access: keep a paper or assisted-consent route for participants who need it [1, 2].
• Ethics committee expectations: committees differ on remote consent and signature types; submit screenshots of the actual REDCap form [2].
• Version drift: an amended form must reach REDCap on the same day it is approved, with a new version number.
• Change management: coordinators need training and a short SOP covering identity checks, re-consent and withdrawals.