Are you planning a registry? You have to first consider, What is our driving question? What is our goal? How will we know, and what happens, when the registry is complete?

Here are 11 steps to planning your next registry:

  1. Articulate the purpose of the registry.
  2. Determine if a registry is an appropriate means to achieve the purpose.
  3. Identify key stakeholders.
  4. Assess feasibility of a registry.
  5. Build a registry team.
  6. Establish a governance and oversight plan:
    • Internal Governance
    • Executive or Steering Committee
    • Scientific Committee
    • Liaison Committee/individual
    • Data Access, Use and Publications Committee
  7. Define the scope and rigor needed.
  8. Define the dataset, patient outcomes, and target population.
    • Three data element domains:
      • Personal Domain
      • Exposure Domain
      • Outcomes Domain
    • Data sources for registries
      • Patient identifier
      • Patient selection criteria
      • Treatments and tests
      • Confounders
      • Cost/resource utilization
      • Disease or condition data
      • Treatment or therapy data
      • Laboratory data
      • Health care provider characteristics
      • Insurance data
  9. Develop a study plan or protocol.
  10. Develop a project plan:
    • Scope
    • Timeline and Schedule Management Plan
    • Cost Management Plan
    • Quality Management Plan
    • Communication Plan
    • Procurement Plan
    • Risk Management Plan
  11. When the registry ends, what happens next?