Once a participant has been matched to your clinical trial through the DecenTrialz pre-screening process, your research site is responsible for determining whether to accept the match for referral and further contact or decline the applicant based on available information. This decision must be based on preliminary eligibility alignment and in accordance with your IRB-approved procedures.

This section outlines how to accept or reject matched participants, the associated responsibilities, and the documentation expectations that support compliance, transparency, and participant respect.

What Does ‘Accepting an Applicant’ Mean?

Accepting an applicant on the DecenTrialz platform means your site:

• Acknowledges that the matched participant appears to preliminarily meet the trial’s inclusion/exclusion criteria
• Agrees to initiate direct outreach or formal screening follow-up
• Accepts responsibility for safeguarding the participant’s contact information and ensuring IRB-compliant communication

Note: Accepting an applicant does not mean the participant is enrolled. It simply advances the process toward further screening and consent, as determined by your internal SOPs.

What Does ‘Rejecting an Applicant’ Mean?

Rejecting an applicant means that, based on pre-screening information:

• The participant does not meet key eligibility criteria
• The trial is no longer recruiting at your site
• The site has reached enrollment capacity
• The participant falls outside of geographic or logistical constraints (e.g., unwilling to travel)

Rejecting a participant:

• Does not notify the participant directly
• Does not impact their ability to match to other studies
• Must be documented with an appropriate reason code (see below)

FAQ: Will the participant know they’ve been rejected?

No. Participants are not directly notified if they are declined. However, they may be eligible for other trials in the future.

How to Accept or Reject a Matched Participant

Site personnel with appropriate access (e.g., Site Administrator, Study Coordinator) can manage applicants via the Match Dashboard:

Accepting a Participant:

1. Click on the participant record in the Match Dashboard.
2. Select “Accept for Outreach” or “Refer to Site Team.”
3. Confirm assignment to a responsible user (e.g., CRC or PI).
4. Securely unlock contact details for follow-up.
5. Log the intended method of communication (e.g., phone, email).

Rejecting a Participant:

1. Click on the participant record.
2. Select “Reject Match.”
3. Choose a reason from the predefined dropdown list:
   • Does not meet age/gender criteria
   • Ineligible condition or medical history
   • Site not enrolling at this time
   • Travel limitations or site location mismatch
   • Duplicate or repeated match
   • Other (with optional free-text comment)
4. Submit and finalize decision, the match will be archived for compliance logging.

Participant Communication Post-Acceptance

Once a participant is accepted:

• Their contact information becomes visible to the assigned user
• The site is responsible for initiating IRB-approved outreach
• Initial contact attempts must be documented within the platform
• All communication must comply with:
  • Your IRB’s consent and script guidelines
  • Institutional communication policies
  • HIPAA and participant privacy protocols

If the participant does not respond after multiple attempts, the status can be marked as “No Response” with corresponding time-stamped logs.

Responsibility & Documentation Requirements

Every action taken on a matched applicant must be:

• Performed by an authorized user
• Time-stamped and linked to the user ID
• Justified with an action reason (for audit traceability)
• Logged automatically in the platform’s compliance audit trail

Sites may export match outcome summaries for:

• Internal SOP review
• Sponsor feasibility reports
• Regulatory audits or IRB reviews

When to Escalate or Hold a Decision

If a participant’s match is borderline or if there is uncertainty regarding:

• Interpretation of eligibility
• IRB language for outreach
• Documentation completeness

The site may mark the record as “On Hold” and:

• Escalate internally to the PI or Regulatory Officer
• Request clarification from DecenTrialz Support
• Await pending IRB approval or protocol amendment

Participants on hold will not be contacted until a decision is logged.

Key Note: Accepting or rejecting a participant is not merely a technical step, it is a regulatory decision point. Each action must be intentional, compliant, and clearly documented. Sites are expected to treat every match with professional discretion, protect participant confidentiality, and act only within the boundaries of approved study criteria and ethical standards.