In the DecenTrialz platform, participant consent is a multi-step process, beginning with digital pre-screening and concluding at the research site after full consent and enrollment procedures. As a research site, your responsibility during the pre-screening stage is to accurately log whether a participant has been:

• Contacted with IRB-approved information
• Provided initial details about the study
• Given the opportunity to ask questions
• Informed that no decisions or commitments are required at this stage

This section outlines how to log consent-related progress ethically and accurately, while remaining fully aligned with U.S. regulations such as 21 CFR Part 50, ICH-GCP, and HIPAA.

What Is Considered ‘Consent Progress’ at the Pre-Screening Stage?

While formal informed consent (signing a full consent form) does not occur until the participant visits or engages with the research site directly, there are important ethical touchpoints that must still be documented.

At the pre-screening stage, consent progress may include:

• Participant has been contacted and acknowledged your outreach
• Participant has received basic study information
• Participant expressed continued interest or requested more information
• Participant verbally agreed to proceed to site-level consent

This process ensures that participants are never enrolled or pressured prematurely and are aware of their rights, including the right to delay or decline.

How to Log Consent Progress in DecenTrialz

To maintain an accurate and auditable record, site teams must use the DecenTrialz platform to log each step taken:

1. Access the Match Dashboard
   • Locate the participant under your active matches list.
2. Open the Consent Progress Panel
   • Select the participant and click on “Log Progress.”
3. Choose the Appropriate Status
   • Contact Attempted – No Response
   • Initial Info Shared – Awaiting Feedback
   • Participant Requested More Info
   • Verbal Interest Confirmed – Ready for Site Consent
   • Participant Declined
4. Add Optional Notes
   • (e.g., “Called on July 2, participant asked for study brochure.”)
5. Save and Timestamp
   • The entry will be locked and added to the audit trail.

Important: This log is not a legal substitute for signed informed consent. It exists solely to document pre-screening communication and participant status as part of early engagement tracking.

Why This Step Is Important

Logging consent progress:

• Ensures transparency and consistency across your site team
• Helps monitor participant interest and readiness
• Supports regulatory documentation during audits
• Protects both the participant and the site from miscommunication
• Enables smoother handoffs between coordinators and investigators

Even if a participant decides not to proceed, logging this accurately helps the platform avoid duplicate follow-ups or unnecessary recontact.

Consent-Related Language to Use During Pre-Screening

To avoid coercion and ensure clarity, use approved phrasing when discussing next steps. For example:

Acceptable:

• “Would you like to receive more information about this study?”
• “You’re welcome to take time before making any decisions.”
• “If you’re still interested, we can set up a time for you to speak with our site team.”

Avoid:

• “You’ve been selected for the study.”
• “We can enroll you today.”
• “This is your only chance to join.”

All communications must reflect voluntariness and allow for participant autonomy.

Exporting Consent Logs for Auditing

Site admins may export consent logs as part of the study documentation package. Export files include:

• Participant ID (de-identified)
• Date/time of status changes
• Action taken and by whom
• Notes (if any)

These logs may be used for:

• IRB reporting
• Sponsor communication
• Site SOP audits

Key Note: Logging consent progress at the pre-screening stage is not just a recordkeeping task, it is an ethical safeguard. It ensures that each participant is approached respectfully, kept informed, and never advanced without their awareness or agreement. Always prioritize clarity, voluntariness, and proper documentation.