Halvey, Patrick
Farutin, Victor http://orcid.org/0000-0002-9220-1461
Koppes, Laura
Gunay, Nur Sibel
Pappas, Dimitrios A.
Manning, Anthony M.
Capila, Ishan
Article History
Received: 15 December 2019
Accepted: 8 January 2021
First Online: 19 January 2021
Ethics approval and consent to participate
: The Corrona-CERTAIN protocol was reviewed and approved by a central IRB, New England Independent Review Board (NEIRB). For academic investigative sites that did not receive a waiver to use the central IRB, full board approval was obtained from the respective governing IRBs and documentation of approval was submitted to the Sponsor prior to initiating any study procedures. Further pertinent details are provided in the publication describing CERTAIN study design characteristics [CitationRef removed]. All CERTAIN subjects were required to provide written informed consent prior to participating. Whole blood for the investigation of the impact of pre-analytical variables through designed experiments was drawn from healthy donors after informed consent was obtained. The collection, handling and biomolecular characterization of blood samples from healthy human volunteers per experimental protocol 102013–001 was approved by the Western Institutional Review Board.
: Not applicable.
: All Momenta-affiliated authors are currently (or were at the time the study was conducted) employees of Momenta Pharmaceuticals Inc., and may own stock and/or stock options in Momenta Pharmaceuticals, Inc. DAP is an employee at Corrona, LLC, and also an instructor at Novartis.