How to Centralize Credential Verification for Local HCPs in Decentralized Clinical Trials (DCTs)
In a recent article, Dan Schnell, Chief Editor at Clinical Leader, talked about the benefits and burdens of involving local healthcare professionals (HCPs) in decentralized clinical trials (DCTs). He mentioned that one of the biggest challenges decision-makers face is verifying that all local HCPS have the proper credentials, licenses, and professional standing to participate.
Since DCTs often rely on HCPs outside the formal research network, there’s an added layer of complexity when it comes to vetting qualifications. Without a streamlined, centralized system in place, it’s easy for things to fall through the cracks.
Although there’s no one-size-fits-all solution, a simple seven-step framework can help point you in the right direction. Here’s a quick breakdown to help you get started:
- Define what you need to verify
Begin by defining what credentials are required for each role. This might include medical licenses, specialty certifications, or professional affiliations. It’ll also vary depending on the region and what the HCP is actually doing in the trial.
Once you have that information, decide:
- Where you’ll get verification data (e.g., licensing boards, professional organizations)
- How often you’ll re-verify (e.g., just at onboarding? annually?)
- How you’ll manage sensitive information in line with GDPR, HIPAA, or other data privacy rules
Setting these parameters up front helps ensure everyone’s working from the same playbook.
- Choose the right technology
There are several technology options for managing credential verification. The one that’s right for you will depend on your budget, scale, and internal resources.
A few options:
- Dedicated credential management platforms: These systems often come with automated workflows, document storage, and alerts for expirations.
- Clinical Trial Management Systems (CTMS): Some CTMS platforms include credentialing modules or allow for third-party integrations.
- Custom-built databases: These work best for smaller studies with specific needs but require IT bandwidth and long-term maintenance.
Whatever system you choose, make sure it checks key boxes: data security, scalability, ease of use, and reporting capabilities.
- Standardize your process
Once you’ve picked a TMS platform, standardize how you onboard HCPs and verify their credentials.
That means:
- Creating clear onboarding instructions
- Offering a secure, user-friendly way for HCPs to upload documents
- Laying out who is responsible for each part of the verification process
- Establishing a consistent method of verification (e.g., primary source checks, third-party services)
- Documenting everything, including when credentials were verified, what source was used, and the outcome
Additionally, build a system to track license expirations and remind HCPs when renewals are due. Discrepancies should follow a predefined escalation path to avoid delays.
- Assign clear roles
Successful credentialing requires coordination and a clear designation of roles. These roles typically fall into one of three categories:
- Credentialing personnel: Whether it’s an internal team or a dedicated vendor, someone needs to own the process.
- Study teams: Define how central and local study staff will support credentialing efforts.
- HCPs: Be upfront about what’s expected. Let providers know what documents they need to provide, their project timelines, and who they can reach out to for help if they run into any issues.
- Provide training and support
Technology is constantly changing. Don’t assume everyone knows how to navigate a credentialing portal or interpret local licensing requirements. To prevent headaches:
- Train internal teams on how the system works and why it matters.
- Offer resources to HCPs, including FAQs, how-to guides, and a dedicated support contact, to smooth out the process and prevent unnecessary back-and-forth.
- Lock down security and compliance
Credential data is sensitive, so make sure your system follows best practices for security and compliance. We recommend you:
- Store data securely with encryption
- Use strict access controls to limit who can view or change records
- Maintain audit trails of all activity
- Conduct regular audits to ensure your processes are working and compliant
These efforts take additional time and planning, but they can help reduce the risk of penalties, fines, and investigations.
- Focus on continuous improvement
Credential verification shouldn’t be a one-and-done process, it requires frequent analysis. Build in regular reviews to improve efficiency and identify pain points. To do that:
- Solicit feedback from study staff and HCPs
- Adjust workflows based on what’s working (or not)
- Stay on top of evolving regulations and update your processes accordingly
Final thoughts
Credentialing local HCPs in DCTs is so much more than a box to check. It’s critical for patient safety, data quality, and regulatory compliance. While the process can feel overwhelming, building a centralized, well-defined system can save time, reduce risk, and make your DCTs more scalable in the long run.
Start with this framework and make it your own. The most effective systems are those that are customized, collaborative, and continuously evolving.
