Home

What Is Required Of An ATHN Affiliate?

Submitted by brazeej on Thu, 09/06/2007 - 11:35am

Collaboration, competence, commitment and compliance are characteristics to be demonstrated by all ATHN Affiliates.  Evidence of these characteristics is listed below.

Collaboration

  • Work cooperatively with other ATHN Affiliates, ATHN management and other participating entities in fulfilling projects and studies to which it has agreed to participate
  • Respond in a timely manner to project inquiries
  • Contribute to the continuous improvement of group processes, products and outcomes related to this important community resource

Competence

  • Deliver multidisciplinary care to patients with bleeding and/or blood clotting disorders through a federally-funded hemophilia treatment center or thrombosis site, OR meet other criteria which may be published by ATHN
  • Ensure that data managers are adequately trained in terms of data definitions, data standards and application systems and accurate, timely data submission

Commitment

  • Use its best efforts to enroll patients into the ATHN database, achieving enrollment and minimum data requirements established by the network
  • Maintain accurate and up-to-date core data for enrolled patients
  • Designate a Principal Investigator to represent the affiliate organization in votes and to serve as the primary contact for communications.  An alternate communications contact may be designated as well.

Compliance

  • Deploy Lab Tracker® -web created by Ground Zero and hosted by the CDC, or other ATHN endorsed patient management software, which will allow the community to share HIPAA compliant non-identifiable patient data through ATHN.
  • Access to an Institutional Review Board (IRB) or willingness to utilize a central IRB adopted by ATHN
  • Assure compliance with regulations related to IRB approvals, Patient Informed Consent, HIPAA Privacy and Security Rule.
  • Adhere to minimum data standards, quality assurance standards, data utilization guidelines, training requirements, publication guidelines or other criteria which may be recommended by ATHN Affiliates and adopted as ATHN policy.


Each ATHN Affiliate will be expected to execute a letter agreement confirming the relationship.

X
Loading