Clinical Site Participation

 

Objectives of the National Patient Registry (NPR)

Primary Objectives
  1. To build a national data repository that will serve as a comprehensive source of longitudinal clinical data to aid in the study of clinicopathologic variations in benign and malignant disorders of the pancreas
  2. To collect patient health data and patient-reported outcomes focused on the following eight domains:
    • Clinical presentation prior to diagnosis;
    • Genetic and epigenetic factors;
    • Lifestyle patterns;
    • Diagnostic features of the pathologic and radiologic evaluations in benign and malignant pancreatic abnormalities;
    • Treatment interventions, including both surgical and non-surgical;
    • Patterns of follow-up, recurrence, and survival for patients treated for benign and malignant pancreatic conditions.

Secondary Objectives:
  1. To collect and maintain data that can be used for future studies to:
    • Objectively measure and determine clinical effectiveness, as well as clinical variance, of healthcare services provided to patients with pancreatic diseases
    • Develop and validate best practices for pancreatic conditions
    • Evaluate the quality of patient care and determine the level of influence per the following variables:
      • Geographical region
      • Type of healthcare facility
      • Type of healthcare providers
      • Point of entry into a healthcare facility
      • Socioeconomic factors
    • Aid in the development of clinical benchmarking related to quality and safety
    • Promote collaborative research among interested investigators by identifying a larger pool of potential research subjects than would be available to these investigators at their own institutions
    • Contribute to the development of personalized medicine for pancreatic diseases
    • Evaluate measures of quality of life in patients with these pancreatic disorders
    • Assess variations in patient satisfaction, adherence, and engagement activities

 

Site Eligibility

Any healthcare facility in the U.S. that provides care for patients diagnosed and/or treated for pancreatic disease is eligible to participate in the NPR.
 

Site Enrollment Process

To become a participating site of the NPR, the healthcare institution must complete the following steps:

  1. Complete the Site Participation Application and submit to NPF via e-mail at registry@pancreasfoundation.org
    • CLICK HERE to download the NPF Registry Site Participation Application
  2. Appoint a qualified individual as the Site Principal Investigator (PI)
  3. Assign a qualified study member as the Site Coordinator/ Administrator
    • Role serves as a designated site contact for the local site
  4. Complete the Site Enrollment Package
    • Distributed by NPF upon receipt of Site Participation Application
  5. Obtain Institutional Review Board (IRB) and/or Ethics Committee (EC) approval
    • Approval must be obtained by one of the following options:
      • NPF’s Central IRB
      • Local site’s IRB (or EC)
  6. Ensure all site research personnel are trained in Human Subject Protections (HSP), Good Clinical Practice (GCP), and health information security and privacy awareness (e.g. HIPAA for Research)
  7. Participate in the NPR Site Training