User's blog

Category: Research Sites

  • Data Retention Standards

    Data retention is a critical aspect of regulatory compliance, ethical accountability, and operational continuity in clinical research. Research sites using DecenTrialz must ensure that all data collected, generated, and stored during the course of trial recruitment and pre-screening is retained in accordance with applicable laws, institutional policies, and sponsor agreements.

    This section outlines the default data retention policies on the DecenTrialz platform, site-level responsibilities, and key considerations under HIPAA.

    What Is Data Retention in the Context of Clinical Trials?

    Data retention refers to the duration for which clinical trial-related data, including participant screening records, communication logs, audit trails, and regulatory documentation, is securely stored and made accessible for verification, monitoring, or inspection.

    Even though DecenTrialz only handles pre-screening and referral activities, records generated during this phase are subject to the same ethical and regulatory scrutiny as those generated during the full study lifecycle.

    Platform-Level Data Retention Policies (DecenTrialz)

    By default, DecenTrialz maintains a minimum data retention period of 6 years, consistent with HIPAA regulations.

    Data stored includes:

    • Pre-screener responses
    • Eligibility outcomes (without PHI unless consented)
    • Communication records with participants
    • Audit logs of site activity
    • Referral timestamps and status history
    • Site user access records

    All retained data is:

    • Encrypted at rest and in transit
    • Time-stamped and version-controlled
    • Hosted on secure U.S.-based servers compliant with HIPAA and 21 CFR Part 11

    No participant-identifiable data is retained beyond the referral stage unless explicitly consented and governed by the research site’s own data handling protocol.

    Site-Level Responsibilities for Retention

    Although DecenTrialz enforces foundational data retention standards, research sites are ultimately responsible for aligning retention practices with:

    • Local IRB or EC (Ethics Committee) policies
    • Institutional SOPs
    • Sponsor contracts
    • National data protection laws (e.g., HIPAA in the United States, GDPR if operating cross-border)

    You must ensure that:

    • Required study logs and reports are downloaded and archived before trial closure
    • PI (Principal Investigator) oversight is maintained for long-term document custody
    • Participant communication notes and eligibility status history are preserved in case of audits

    Sites may export DecenTrialz-generated data to their internal systems using the “Download Record Archive” feature prior to trial archival.

    Retention of Consent-Related Records

    Even during the pre-screening stage, some communications (such as expressions of interest or voluntary opt-ins) may constitute limited informed consent records. These must also be retained for a minimum of 6 years, or longer if your IRB or sponsor requires.

    If your site collects any additional documentation from participants outside of the DecenTrialz system (e.g., handwritten notes, phone transcripts), retention of those records must also follow institutional policy.

    Data Destruction After Retention Period

    At the end of the applicable retention period:

    • DecenTrialz will notify site administrators prior to scheduled data archiving or destruction
    • Sites may request extended retention or secure export for permanent archiving

    Sites must not delete any data prematurely without written authorization from the sponsor and/or IRB.

    Key Note: Maintaining accurate, secure, and complete data records is an ethical obligation and a legal requirement. Failure to retain data for the appropriate duration can lead to regulatory penalties, audit deficiencies, or even trial invalidation. Always confirm your site’s retention policy with your IRB or institution’s research office and document all retention-related decisions for audit readiness.

  • Reporting to Sponsors

    Timely and transparent communication with study sponsors is a critical responsibility for all research sites. The DecenTrialz platform is equipped with features that support standardized, audit-ready reporting to sponsors at every phase of participant engagement and study operations,  particularly during the pre-screening and referral process.

    This section outlines what information can be shared with sponsors, how to generate reports from the platform, and the ethical and regulatory considerations for site-to-sponsor communication.

    What Can Be Reported to Sponsors via DecenTrialz?

    Sponsors may require regular updates from sites to track recruitment progress, assess protocol adherence, and ensure overall study performance. The DecenTrialz platform enables sites to report pre-screening-level data that is:

    • De-identified (unless explicit participant consent allows otherwise)
    • Aggregated or participant-level, depending on sponsor needs and IRB allowances
    • Fully aligned with ICH-GCP, HIPAA, and 21 CFR Part 11 requirements

    Typical reporting categories include:

    Report TypeDetails Shared
    Prescreening Funnel MetricsNumber of pre-screeners started, completed, disqualified
    Referral ActivityNumber of participants referred, referral timestamps
    Eligibility TrendsCommon inclusion/exclusion barriers (non-identifiable)
    Participant DispositionInterested, declined, unreachable, withdrawn (no PHI shared)
    Communication LogsContact attempt dates, no content of messages shared

    Important: Sites must never share identifiable health data or direct participant contact details with sponsors unless:

    • Explicit consent has been obtained
    • Sharing is IRB-approved
    • Required by a regulatory agreement and properly documented

    How to Generate Reports for Sponsors

    Site admins and delegated coordinators can generate sponsor-ready reports directly from the Reporting Module on DecenTrialz.

    To Create a Sponsor Report:

    1. Navigate to Dashboard → Reporting → Sponsor Reports
    2. Select your trial of interest
    3. Choose reporting period (e.g., weekly, monthly, custom)
    4. Select metrics to include:
      • Referral stats
      • Pre-screener conversion
      • Communication status
      • IRB document updates (if applicable)
    5. Click Generate Report
    6. Download in PDF or CSV format, or securely share via sponsor-facing portal link (if activated)

    All reports are automatically:

    • Timestamped and version-controlled
    • Watermarked with trial ID and your site code
    • Backed by corresponding audit logs (see Section 5.3.1)

    Sponsor Portal Access (Optional)

    If enabled by the sponsor and permitted by the site, certain designated sponsor representatives may receive read-only access to a real-time recruitment dashboard.

    Sponsor views are:

    • Permission-controlled
    • Anonymized by default
    • Monitored by the platform to prevent data misuse

    You may control what metrics are shared and revoke access at any time via the Site Admin Panel.

    Regulatory and Ethical Responsibilities

    When reporting to sponsors, your site must adhere to the following standards:

    • Do not overstate or understate enrollment progress
    • Avoid sending reports via unsecured or personal email
    • Ensure internal consistency between platform data and your own site SOP logs
    • Include IRB reference numbers when submitting updates on approved protocol changes

    Sponsors rely on site-reported data to make trial-wide decisions, including budget adjustments, site activation status, and recruitment strategy shifts. Accuracy and ethical rigor are essential.

    Key Note: All sponsor reports generated through DecenTrialz are designed to protect participant confidentiality while ensuring full transparency around recruitment and referral activity. When in doubt, always confirm with your site PI or IRB liaison before sharing sensitive or detailed metrics.

  • Logging Consent Progress (Pre-Screening Stage Only)

    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.

  • Communication Etiquette

    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:

    PrincipleDescription
    Respect & DignitySpeak with empathy. Acknowledge their time, interest, and right to ask questions or decline.
    Clarity & SimplicityUse plain, accessible language. Avoid complex medical terms unless the participant asks.
    TransparencyClearly state your name, role, the trial name, and why you are contacting them.
    VoluntarinessEmphasize that participation is voluntary and that they may opt out at any time.
    No PressureNever use urgency, guilt, or incentives to pressure participation or scheduling.
    Privacy RespectConfirm 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.

  • Accepting or Rejecting Applicants

    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.

  • Understanding Your Dashboard

    The Site Performance Dashboard on DecenTrialz provides real-time insights into participant engagement, recruitment effectiveness, referral progress, and site-specific activity. This centralized view helps Principal Investigators (PIs), Site Coordinators, and Research Administrators make informed operational decisions while ensuring compliance with sponsor expectations and regulatory benchmarks.

    This section provides a comprehensive overview of the dashboard’s features, data visualization tools, interpretation guidance, and role-based visibility settings.

    Purpose of the Dashboard

    The dashboard is designed to:

    • Present a real-time view of participant activity across all live and draft trials hosted by your site
    • Highlight trends in eligibility, referral, and outreach outcomes
    • Surface bottlenecks or drop-offs in the pre-screening process
    • Support recruitment planning and capacity forecasting
    • Facilitate internal and sponsor reporting through exportable charts and tables

    It functions as a mission control panel for your site’s performance on the DecenTrialz platform.

    Key Metrics Displayed

    Each dashboard is tailored to your site’s user role (e.g., Admin, Coordinator, PI) and includes the following data panels:

    MetricWhat It ShowsHow to Use It
    Trial Status SummaryNumber of trials in Draft, Live, Paused, or Closed statusTrack activation pipeline and active enrollment periods
    Pre-Screeners CompletedTotal and per-trial breakdownIdentify trials with strong vs. weak engagement
    Eligibility Pass Rate% of participants who met inclusion/exclusion criteriaAdjust outreach messaging or site targeting if needed
    Referral ActivityCount of participants referred, with time stampsAssess time-to-referral and team responsiveness
    Participant DispositionOutcome of each referral (Interested, Declined, No Show)Improve follow-up workflows and participant communication
    Avg. Time to Review Pre-ScreenerTime between participant submission and site reviewOptimize site staffing or auto-reminders if delays occur
    Outreach Attempts LoggedNumber of site-initiated contact attempts (no PHI)Monitor follow-through by coordinator teams

    Note: All displayed data is de-identified by default. Participant-level views are accessible only to users with appropriate role permissions and after referral.

    Interactive Features

    The dashboard is not static, users can interact with charts and filter data based on:

    • Trial (individual or grouped view)
    • Date range (e.g., last 7 days, monthly, custom)
    • Coordinator activity (to monitor internal performance)
    • Referral status (to track participant flow stage-by-stage)

    You can also click on any chart element (e.g., a data bar or trendline) to drill down into the specific data table powering that visualization.

    Role-Based Access

    To ensure data security and ethical transparency, dashboard access is governed by user role:

    RoleView Level
    Site AdminFull access to all trials, metrics, and user performance
    Study CoordinatorAccess to assigned trials and participant interactions only
    PI / InvestigatorFull trial-level visibility but cannot modify admin settings
    Sponsor Liaison (if granted)Read-only, de-identified data view for performance audits

    If a staff member changes roles or responsibilities, site administrators can update permissions via the Admin Panel → User Management section.

    Exporting Data for Internal Use or Sponsor Review

    You may export dashboard data in multiple formats:

    • CSV: For spreadsheets or internal performance trackers
    • PDF: For sponsor presentations or IRB reports
    • Dashboard Snapshot: Save current screen as a visual (for briefings)

    Exports are watermarked with trial and site ID for version control and stored securely in your Reporting Archive tab.

    Troubleshooting Dashboard Discrepancies

    If you notice incorrect, missing, or outdated information on your dashboard:

    1. Check your date filters and ensure the correct trial is selected.
    2. Confirm your user role allows access to the trial or metric in question.
    3. Use the “Refresh Dashboard” button to pull the latest data.

    FAQ: What if our site changes Principal Investigators (PI)?
    Update the PI in your site settings and notify DecenTrialz Support. IRB documentation for the new PI will be required to maintain compliance.

    If issues persist, contact DecenTrialz Support at support@decentrialz.com with your Site ID and a screenshot of the problem.

    Key Note: Your dashboard is not just a reporting tool, it’s an operational command center. Use it to anticipate problems, validate success, and maintain regulatory readiness. Data visibility supports better recruitment planning, faster decisions, and more effective site management.

  • Digital Audit Trails

    In clinical research, accurate documentation is not only a regulatory requirement but also a foundational aspect of ethical trial conduct. Digital audit trails within the DecenTrialz platform ensure that all participant-related actions, data access, and communication events are transparently recorded, time-stamped, and traceable.

    This section outlines how audit trails are maintained, what actions are tracked, who has access to audit logs, and how they support regulatory compliance for sites, sponsors, and IRBs.

    What Is a Digital Audit Trail?

    A digital audit trail is an automated, system-generated log that records the who, what, when, and how of every significant action taken within the platform.

    These logs are:

    • Immutable (cannot be edited after recording)
    • Time-stamped with date and time
    • Linked to specific user accounts and site roles
    • Stored securely in accordance with 21 CFR Part 11 and HIPAA standards

    Purpose: To provide complete accountability, support internal QA/QC, and enable defensible evidence during audits or regulatory inquiries.

    FAQ: Can our site request a log export for only one user?

    Yes. Use the filter tools in the Audit Log panel to generate reports by user role, action type, or date.

    Which Actions Are Tracked?

    The platform logs and preserves all material interactions related to trial management and participant engagement, including but not limited to:

    Action TrackedExamples
    User login and session activityLogin time, logout, failed attempts
    Trial creation or status updatesMarking a study as Live, Paused, Closed
    Participant match viewingWhich user viewed which match and when
    Consent progress loggingStatus changes, notes added
    Document uploadsIRB forms, eligibility criteria
    Participant communicationContact attempts, message timestamps
    User permission changesRole assignment, deactivation, reassignments
    Data exports or report generationMatch CSV exports, dashboard PDF downloads

    Each log entry contains:

    • Timestamp (UTC)
    • User ID and role
    • Site name and trial ID
    • Action type
    • Device metadata (e.g., IP address)

    Where to Access Audit Logs

    Site Administrators have full access to their site’s audit logs through the Compliance & Reporting Panel in their dashboard.

    • Navigate to Dashboard → Compliance → Audit Logs
    • Apply filters (date range, user role, trial ID)
    • Export reports (CSV, JSON, PDF)
    • Downloadable logs include platform watermark and authentication hash

    All logs are encrypted at rest and in transit. Logs are retained in compliance with HIPAA (minimum 6 years) and can be extended to meet sponsor or IRB-specific retention policies.

    Why Audit Trails Matter

    Audit trails:

    • Support regulatory readiness: Required by FDA, OHRP, and IRB bodies
    • Protect participant safety: Detect unusual access or communication patterns
    • Reduce compliance risk: Enable proactive review before issues arise
    • Ensure internal accountability: Hold staff and collaborators to SOP-aligned practices

    Best Practices for Sites

    • Review logs regularly during high-volume recruitment periods
    • Assign access based on minimum-necessary permissions
    • Escalate anomalies (e.g., data viewed outside working hours, access by wrong role)
    • Document corrective actions taken in response to any discrepancies

    If a user error or protocol deviation is detected via logs, report it immediately to your IRB and DecenTrialz Support.

    Key Note: Audit trails are not just a backend function,  they are your first line of defense in regulatory inspections. Proper use demonstrates transparency, preparedness, and ethical commitment to participant protection. All site staff should be trained to understand the role of audit logs and their implications.

  • Viewing Matches

    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 RoleAccess Permissions
    Site AdministratorFull access to all matches, filters, and exports
    Principal InvestigatorView participant data for trials they are assigned to
    Study CoordinatorView, filter, respond to, and document match actions
    Regulatory StaffNo 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.

  • Who Can Register as a Site

    To ensure participant safety, ethical oversight, and regulatory alignment, only verified and qualified research organizations may register as sites on the DecenTrialz platform. Registration grants access to tools for managing clinical trials, receiving pre-screened participants, and maintaining compliance across the trial lifecycle.

    This section outlines which types of institutions are eligible to register, who is not permitted to register, what baseline requirements must be met, and how DecenTrialz evaluates site-level readiness before access is granted.

    Overview: Who Qualifies as a Research Site

    A research site is defined as a physical or virtual location that conducts one or more components of a clinical trial, under the direction of a licensed Principal Investigator (PI), and with oversight by an Institutional Review Board (IRB) or Ethics Committee.

    To qualify for registration on DecenTrialz, an organization must:

    • Be legally registered in its operating jurisdiction
    • Be capable of conducting human subject research under GCP
    • Be affiliated with at least one licensed PI
    • Be covered by IRB or equivalent ethical oversight

    Eligible Entity Types

    The following categories of organizations are considered eligible for site registration:

    1. Academic Medical Centers

    Universities, medical colleges, and affiliated research hospitals that operate formal clinical trial units or research departments. These institutions often conduct both investigator-initiated and sponsor-supported studies.

    Examples include:

    • University hospitals with clinical research offices
    • Teaching hospitals with PI-led trials
    • NIH-funded academic research consortia

    2. Independent Research Clinics / Private Trial Units

    Privately owned research centers that specialize in clinical trials across one or more therapeutic areas, and that maintain their own IRB affiliations or use a central IRB.

    Examples include:

    • Standalone clinical trial sites with dedicated CRCs
    • Community-based research clinics

    Note: Must provide proof of GCP adherence, PI oversight, and ethical governance.

    3. Hospital-Based Research Departments

    Specialty or general hospitals that maintain in-house research programs. These may be part of a larger health system or independently operated but must demonstrate:

    • Research-specific infrastructure
    • Staff training in clinical trial operations
    • Protocol management processes

    4. Site Management Organizations (SMOs)

    Organizations that manage multiple research sites under centralized administration. SMOs may register individual sites under a network structure or request umbrella access with linked sub-sites.

    Requirements include:

    • Documentation of site relationships
    • Central IRB usage where applicable
    • Oversight structure for sub-site activity

    5. Integrated Research Networks / Investigator Groups

    Multi-location research groups or collaborative physician networks conducting decentralized, community-based, or hybrid trials. Must designate a lead administrative site and PI.

    Baseline Requirements for Site Registration

    Every entity must meet the following minimum standards:

    RequirementDescription
    Legal RegistrationMust be a recognized business entity with a valid Tax ID, EIN, or local equivalent
    Principal Investigator (PI)One or more licensed PIs responsible for trial oversight and participant safety
    IRB or Ethics ApprovalValid affiliation with a central or local IRB/EC with documentation on file
    Data Security CapabilityMust be capable of storing and managing participant data in accordance with HIPAA, GCP, and relevant local regulations
    Designated Site AdministratorOne individual accountable for platform access, user permissions, and document maintenance

    Accountability and Oversight Expectations

    Upon approval, each research site is expected to:

    • Operate in accordance with ICH-GCP guidelines
    • Maintain accurate credentials and IRB documents
    • Assign qualified staff to platform-based workflows (e.g., pre-screening follow-up, referral tracking)
    • Ensure communication with participants is ethically appropriate and IRB-compliant
    • Cooperate with platform-based audits or data verification processes when required

    Who Can’t Register as a Site?

    The following groups or individuals are not permitted to register as sites:

    Ineligible ApplicantReason
    Individual investigators without site affiliationPlatform requires organizational accountability and IRB governance
    Contract staff, consultants, or freelancersLack of institutional oversight, unclear responsibility chain
    CROs or Sponsors acting as their own sitesConflicts of interest; platform separates sponsor and site functions
    Sites without IRB oversightAll participant referrals must be governed by IRB-approved protocol and safety procedures
    Unlicensed facilities or pop-up unitsShould meet applicable state and national regulations to qualify for ethical research participation for human subject research

    Note: Any attempt to register using falsified information or without meeting the above criteria may result in permanent suspension from the platform.

    Key Note: If you’re unsure whether your site qualifies, you may contact DecenTrialz Support at support@decentrialz.com with your credentials for a preliminary check. We encourage early engagement before formal application.

    Multi-Site or Networked Sites

    Organizations that operate across multiple locations may request centralized account access with sub-site configurations. Approval will depend on:

    • Documentation of relationship between central and satellite locations
    • IRB coverage for each location or shared protocol
    • Appointment of sub-site administrators with clearly defined permissions

    Key Note: Site registration is not simply a technical step; it is a regulatory commitment. Only entities that demonstrate ethical, legal, and clinical readiness to engage in human subject research are permitted to operate on the DecenTrialz platform. Our team reviews each application carefully to protect the integrity of the research ecosystem and the rights of participants.