Category: Managing Participants

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.

Effective and respectful communication with matched participants is a critical component of ethical clinical research. As soon as your site chooses to accept a participant through the DecenTrialz platform, all subsequent interactions whether via phone, email, SMS, or another approved method, must align with institutional review board (IRB) guidelines, participant rights, and industry regulations.

This section outlines the principles and expectations for site-to-participant communication during the pre-screening and referral process.

Why Communication Matters

Each participant matched to your site is a prospective volunteer who has:

• Taken the time to complete a health-based pre-screener
• Expressed interest in learning more about clinical research
• Not yet committed to enrollment or in-person screening

The goal of your communication is not to convince or enroll, but to inform, answer questions, and support the participant’s decision-making process. This includes helping them understand what to expect and whether the study may be right for them, without pressure or bias.

Core Communication Principles

When contacting a matched participant, site staff must follow these principles:

Principle	Description
Respect & Dignity	Speak with empathy. Acknowledge their time, interest, and right to ask questions or decline.
Clarity & Simplicity	Use plain, accessible language. Avoid complex medical terms unless the participant asks.
Transparency	Clearly state your name, role, the trial name, and why you are contacting them.
Voluntariness	Emphasize that participation is voluntary and that they may opt out at any time.
No Pressure	Never use urgency, guilt, or incentives to pressure participation or scheduling.
Privacy Respect	Confirm the participant’s identity discreetly before discussing study details.

Before You Initiate Contact

Before making contact, site teams must:

• Confirm the participant has been formally accepted in the Match Dashboard
• Review their pre-screener responses to tailor your outreach appropriately
• Use only the IRB-approved contact script or templates stored in your site’s communication library
• Determine the best time and method for outreach based on participant-provided preferences (when available)

Reminder: Participants may withdraw their interest at any time. If a participant communicates withdrawal, mark the record accordingly and cease further contact.

What to Say in the First Message or Call

Your initial outreach should include the following elements:

1. Your name and institutional affiliation
   (e.g., “Hello, my name is Dr. Patel, and I’m a research coordinator at ABC Medical Center.”)
2. Mention of DecenTrialz referral
   (e.g., “You recently filled out a brief survey on DecenTrialz, and based on your answers, we’d like to share more about a study we’re conducting.”)
3. Clarification of next steps
   (e.g., “This call is just to provide information. You can take your time before deciding whether to move forward.”)
4. Respect for time and consent to proceed
   (e.g., “Is this a good time to speak, or would you prefer to schedule a follow-up?”)

Recording Calls

Some jurisdictions require participants to be notified if a call is being recorded. If your site records outreach for training or compliance, always obtain verbal consent (e.g., “With your permission, this call may be recorded for quality purposes.”)

Do’s and Don’ts of Participant Communication

Do:

• Use professional, polite language
• Let the participant lead the pace of the conversation
• Provide IRB-approved study facts
• Log each contact attempt and response in the platform

Don’t:

• Promise benefits or outcomes
• Misrepresent the nature of the study
• Use phrases like “you have been selected” (unless IRB-approved)
• Discuss non-study-related health advice

Handling Sensitive Scenarios

If a participant:

• Expresses fear or uncertainty: Acknowledge their concerns and offer to provide official materials or follow-up later.
• Requests a copy of the consent form early: Refer them to the site’s standard process or send pre-consent material, if approved.
• Mentions previous negative trial experiences: Remain empathetic and non-defensive. Offer support without persuasion.

All team members must complete DecenTrialz communication compliance training before outreach begins.

Inclusivity Note: If a participant appears to require additional language support or accessibility accommodations, refer to your institution’s translation and communication assistance policies. DecenTrialz also offers template guidance in multiple languages upon request.

Documenting Your Outreach

Every communication attempt must be logged in the system with:

• Date and time
• Type (call, email, SMS, etc.)
• Outcome (spoke, no answer, follow-up needed)
• Notes (optional but recommended for continuity)

This log supports audit readiness and protects participant safety and site integrity.

Key Note: Communication with participants is not just outreach, it is a reflection of your site’s professionalism, ethical standards, and commitment to human research protection. Treat every interaction with care, transparency, and respect. Always defer to IRB guidance when in doubt, and never substitute informal practices for approved protocol.

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.

Once a trial is listed and live on the DecenTrialz platform, eligible participants who complete the pre-screening process may be algorithmically matched to that study. This section explains how site personnel, under the supervision of the Site Administrator, can view and manage participant matches in a secure, compliant, and auditable manner.

What Is a Match?

A “match” occurs when a participant’s pre-screening responses align with the basic inclusion/exclusion criteria set by your site during trial setup. A match indicates that the participant may be eligible and has shown interest in learning more about your study. However, final eligibility must still be determined through your site’s standard screening and consent process.

Note: DecenTrialz only facilitates pre-screening and referral. It does not make medical determinations or replace site-level screening.

Who Can View Matches

Only authorized site personnel with one of the following roles may access the Match Dashboard:

User Role	Access Permissions
Site Administrator	Full access to all matches, filters, and exports
Principal Investigator	View participant data for trials they are assigned to
Study Coordinator	View, filter, respond to, and document match actions
Regulatory Staff	No access to participant data
Viewer (Read-Only)	View-only access, no interaction or logging rights

All user activity is logged and timestamped for audit purposes.

Example Workflow by Role

• Site Admin: Logs in daily to review all new matches, assigns team leads.
• Study Coordinator: Filters for matches by date, logs outreach, and updates status.
• PI: Reviews final referral list before screening begins.

Where to View Matches

Matches can be accessed via the “Match Dashboard”, which is available under the “Participants” tab of each trial listing. The dashboard displays:

• Participant initials or anonymized ID
• Match status (New, Reviewed, Action Taken)
• Date of match and time of pre-screener completion
• Key matching tags (e.g., age range, condition match, location proximity)
• Communication status (e.g., outreach pending, in progress, completed)

No sensitive identifiers (e.g., full name, contact info) are shown until the site confirms interest and data-sharing compliance.

Filtering and Sorting Options

To streamline your workflow, the Match Dashboard offers advanced filtering by:

• Match date
• Trial arm (if applicable)
• Eligibility confidence score (based on pre-screener accuracy)
• Participant proximity (by ZIP/postal code or region)
• Outreach status (not contacted, contacted, declined, referred)

These filters help prioritize outreach efforts and ensure timely follow-up.

Best Practices for Reviewing Matches

1. Check daily for new matches: Especially during active recruitment windows.
2. Prioritize high-probability matches: Use filters to target participants meeting multiple core criteria.
3. Document all review actions: Whether proceeding, declining, or requesting additional info, all actions must be logged.
4. Coordinate internally: Assign matches to appropriate site staff using built-in assignment tools.

Data Security and Access Control

• All match data is stored on HIPAA-compliant, access-controlled servers.
• Participants remain anonymous until your site formally opts to initiate outreach.
• Match data must not be downloaded or stored externally unless authorized under your institution’s data policy and participant consent provisions.
• Any suspected misuse or unauthorized access must be reported immediately to DecenTrialz Support.

Audit-Ready Logs and Reporting

• All user activity on the Match Dashboard is timestamped and linked to platform user IDs.
• Site administrators can export match logs (CSV or PDF) for internal records or sponsor reporting.
• All exports are watermarked and include metadata for audit traceability.

Key Note: Viewing a participant match is the beginning,  not the end of the engagement process. Sites must follow up ethically, respectfully, and in accordance with IRB-approved communication templates and consent policies. Misuse of match data or failure to document outreach may result in platform-level compliance action.