ClinicalPath Trial Placement Policy

Clinical trial placement will follow ClinicalPath’s placement and disclosure practice, which may be updated from time to time. Clinical trials will be placed into ClinicalPath only for those hospital and provider customers who have approved their inclusion.

In an effort to increase and maintain the number of available clinical trials, Elsevier may license access to ClinicalPath Trial Manager to sponsors as defined in 21 CFR 312.3 Investigational New Drug Application and which may include pharmaceutical companies, to submit inclusion and exclusion criteria of clinical trials to Elsevier. All sponsor submitted inclusion and exclusion criteria are reviewed by Elsevier prior to being included in ClinicalPath.

Editorial Independence

Elsevier has a firewall policy to ensure editorial independence in order to protect the integrity of the recommendations and information presented in the ClinicalPath clinical decision support system. The Elsevier editorial team reserves the right to review, edit, accept, and reject sponsor submitted inclusion and exclusion criteria for clinical appropriateness. The Elsevier editorial team will not provide feedback regarding decisions on the final placements within ClinicalPath following its review.

Data

ClinicalPath Trial Manager only uses hospital, provider, and patient data that has been de-identified consistent with HIPAA requirements and only as permitted under a valid data use agreement.

Anti-Kickback Statute

Elsevier ensures that commercial transactions in connection with ClinicalPath Clinical Trial Manager are in compliance with the Federal Healthcare Programs Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)) and the RELX Code of Ethics and Business Conduct(Wird in neuem Tab/Fenster geöffnet).

Formularies and Guidelines

Any employee, subcontractor, or agent of Elsevier involved with the development or delivery of ClinicalPath Trial Manager who is or becomes a member of a committee that sets formularies of covered medicines or develops clinical practice guidelines or treatment protocols or standards, shall comply with the disclosure requirements of the respective committee(s), and at a minimum disclose their development or delivery of ClinicalPath Trial Manager to the respective committee(s).