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:
| Requirement | Description |
| Legal Registration | Must 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 Approval | Valid affiliation with a central or local IRB/EC with documentation on file |
| Data Security Capability | Must be capable of storing and managing participant data in accordance with HIPAA, GCP, and relevant local regulations |
| Designated Site Administrator | One 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 Applicant | Reason |
| Individual investigators without site affiliation | Platform requires organizational accountability and IRB governance |
| Contract staff, consultants, or freelancers | Lack of institutional oversight, unclear responsibility chain |
| CROs or Sponsors acting as their own sites | Conflicts of interest; platform separates sponsor and site functions |
| Sites without IRB oversight | All participant referrals must be governed by IRB-approved protocol and safety procedures |
| Unlicensed facilities or pop-up units | Should 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.