7 Steps To Manage Local HCPs In A Decentralized Trial

By Dan Schell, Chief Editor, Clinical Leader

In my article Local HCPs in DCTs: Big Benefits, Bigger Burdens?, I mentioned the need to implement a centralized system to verify the credentials, licenses, and professional standing of all local healthcare professionals (HCPs) participating in a DCT. There’s no right or wrong way to do this, but I did want to follow up and give you this multi-step process that you could use as a template and customize as needed.

1. DEFINE THE SCOPE AND REQUIREMENTS:

• Identify Required Credentials: Determine the specific credentials, licenses, certifications, and professional affiliations that are necessary for each type of local HCP involved in the trial, based on their roles and responsibilities. This will vary depending on the country, region, and the specific tasks they will perform.
• Establish Verification Criteria: Define the acceptable sources and methods for verifying each credential (e.g., primary source verification, online databases, professional organizations).
• Determine Frequency of Verification: Decide how often credentials need to be verified (e.g., at onboarding, annually, or if there are any changes in their status).
• Consider Data Privacy and Security: Plan how sensitive personal and professional data will be collected, stored, and accessed in compliance with relevant data privacy regulations (e.g., GDPR, HIPAA).

2. CHOOSE A TECHNOLOGY PLATFORM:

• Dedicated Credential Management System: Consider using a dedicated credential management software platform designed for healthcare or clinical research. These systems often offer features like automated verification workflows, document management, and expiration tracking.  
• Clinical Trial Management System (CTMS): Some CTMS platforms have built-in credential management modules or the ability to integrate with external credentialing systems.
• Custom-Built Database: For smaller trials or organizations with specific needs, a secure, custom-built database might be an option, but it requires significant IT resources for development and maintenance.
• Factors to Consider: When selecting a platform, consider factors like security, scalability, user-friendliness, integration capabilities, reporting features, and cost.

3. DEVELOP STANDARDIZED PROCESSES AND WORKFLOWS:

• HCP Onboarding Process: Integrate credential verification seamlessly into the HCP onboarding process. Clearly outline the required documents and the steps involved for the HCP.
• Document Collection: Establish a secure and efficient method for collecting required documents from local HCPs (e.g., secure online portal, encrypted email). Provide clear instructions and support to HCPs during this process.
• Verification Workflow: Define a clear workflow for the verification process, including who is responsible for each step (e.g., a dedicated credentialing team, study coordinator).
• Verification Methods: Implement the chosen verification methods (e.g., direct contact with licensing boards, accessing online databases, using third-party verification services).
• Documentation of Verification: Maintain a clear and auditable record of all verification activities, including the date of verification, the source of information, and the outcome.  
• Expiration Tracking and Renewal: Implement a system to track the expiration dates of licenses and certifications and trigger reminders for renewal. Establish a process for verifying renewed credentials.
• Handling Discrepancies: Define a clear process for addressing any discrepancies or issues identified during the verification process. This may involve requesting additional information from the HCP or escalating the issue to the appropriate personnel.

4. ASSIGN ROLES AND RESPONSIBILITIES:

• Dedicated Credentialing Team/Personnel: Consider assigning specific individuals or a team responsible for overseeing the credential verification process. This ensures expertise and consistency.
• Study Team Responsibilities: Clearly define the roles and responsibilities of the central study team and local study coordinators in supporting the credential verification process.
• HCP Responsibilities: Clearly communicate the HCP's responsibilities in providing accurate information and necessary documentation.

5. IMPLEMENT TRAINING AND SUPPORT:

• Training for Internal Teams: Provide thorough training to the central study team and anyone involved in the credential verification process on the system, procedures, and relevant regulations.
• Support for Local HCPs: Offer clear instructions, FAQs, and dedicated support channels to assist local HCPs with the credential submission process.

6. ENSURE DATA SECURITY AND COMPLIANCE:

• Secure Data Storage: Store all sensitive credentialing information in a secure and compliant manner, adhering to data privacy regulations.  
• Access Control: Implement strict access controls to limit who can view and modify credentialing data.  
• Audit Trails: Maintain comprehensive audit trails of all actions taken within the credential management system.
• Regular Audits: Conduct regular audits of the credential verification process and system to ensure accuracy, compliance, and identify areas for improvement.

7. CONTINUOUS IMPROVEMENT:

• Regular Review of Processes: Periodically review and update the credential verification processes to ensure they remain efficient and effective.
• Feedback Mechanisms: Gather feedback from both internal teams and local HCPs to identify challenges and opportunities for improvement.
• Stay Updated on Regulations: Continuously monitor changes in relevant regulations and guidelines related to healthcare professional licensing and credentialing.

By implementing these steps, sponsors and CROs can establish a robust and centralized system for verifying the credentials, licenses, and professional standing of local HCPs in DCTs, ensuring patient safety, data integrity, and regulatory compliance.

For more on DCTs, be sure to check out our resource page “A Guide For Managing Decentralized Clinical Trials.”