Clinical Research Collaboration

Interested in working with us on a clinical trial? Learn more about our qualifications, credentials and protocols.

• What accreditations and certifications does Seattle Children’s hold?

  Our accreditations and certifications include:

  • ACS: American College of Surgeons
  • ASHP: American Society of Health System Pharmacies
  • CMS: Centers for Medicare and Medicaid Services Transplant and End Stage Renal Disease (ESRD)
  • CAP: College of American Pathologists
  • CARF: Commission on Accreditation for Rehabilitation Facilities
  • CLIA: Clinical Laboratory Improvement Act/Amendment
  • Magnet American Nurses Credentialing Center
  • DNV: Det Norske Veritas Hospital Accreditation
  • WA Department of Health (DOH): Hospital License, Behavioral Health Agency (BHA), Radiology
  • FACT: Foundation for Accreditation of Cellular Therapy
  • NAEC: National Association of Epilepsy Centers
  • DICOE: Diagnostic Imaging Center of Excellence
  • UNOS: United Network for Organ Sharing

  Back to Top
• What are the qualifications of your lab personnel and clinical research staff?

  All research lab personnel maintain current Human Subjects Protection (HSP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) training, and International Air Transport Association certification. All clinical research staff are required to complete GCP and HSP training every three years and maintain their licensure per their roles and responsibilities.

  Back to Top
• Do you have site-required language for consents?

  Yes, we have institutionally required language for study costs, payment for participation, compensation for injury and confidentiality/privacy.

  Back to Top
• How does your site optimize participant recruitment?

  Every study is different, and so are its recruitment and retention needs. Based on the specific goals of the trial and the available recruitment budget, we develop a tailored participant recruitment plan. This plan taps into a mix of strategies and creative tactics designed to attract, engage and retain the right participants.

  Some strategies include:

  • Clinic- and community-based referrals
  • Clinical data repository (CDR) housed by TriNetX
  • Institutional resources such as the Community Engagement Core
  • Printed materials
  • Recruitment through MyChart
  • Social media posts
  • Targeted advertising
  • Website posts

  Back to Top
• What are the steps to study activation?

  First, Seattle Children’s receives all applicable regulatory, budget, contract and operational documents, including the protocol, investigator brochure(s), unlocked budget and contract templates, and study-specific manuals for any clinical service. We require all these documents to proceed with budget and contract development.

  The Clinical Research Support Office then performs feasibility analysis and coverage analysis review, and conducts internal study budget meetings. Once that is complete, the Clinical Research Support Office initiates the budget and contract negotiation.

  Study teams may then complete regulatory documents and submit them for IRB review in parallel with budget and contract review. Or they may wait to submit to the reviewing IRB until the budget and contract terms have been agreed upon before IRB submission.

  Operations teams will then build study-specific order sets into Epic, clinical trial management calendars and billing protocol.

  Once we receive regulatory approval, we execute the budget and contract. The study sponsor conducts a site initiation visit, internal systems are signed off as accurate and complete, and the study team confirms receipt of all supplies and study products.

  Finally, the study is open to accrual and can start recruitment.

  Back to Top