title: Consensus recommendations on rater training and certification.
abstract: There is currently no accepted standard for the clinical research industry to follow when selecting and training raters to administer rating scales in clinical neuroscience trials. This article offers guidelines, based on expert recommendations of the CNS Summit Rater Training and Certification Committee, for selecting, training, and evaluating raters. The article also defines terminology and offers recommendations for considering raters with prior training and certification. These guidelines are intended for investigators, pharmaceutical companies, contract research organizations, and other entities involved in clinical neuroscience trials.
authors.affiliation: Mr. West is Principal Consultant with Innovum Research, Las Vegas, Nevada (was with ePharmaSolutions, Plymouth Meeting, Pennsylvania, at the writing of this article); Dr. Daniel is Senior Vice President, Chief Medical Director, Bracket Global LLC and is with the Department of Psychiatry and Behavioral Sciences, George Washington University, McLean, Virginia; Dr. Opler is Chief Scientific Officer, Founder, ProPhase LLC, New York, New York; Dr. Wise-Rankovic is Vice President, CNS Clinical Development, INC Research, Raleigh, North Carolina; and Dr. Kalali is Professor of Psychiatry, University of California, San Diego, and Vice President, Global Head, Neuroscience Center of Excellence, Quintiles, San Diego, California.
authors.forename: Mark D
authors.initials: MD
authors.lastname: West
authors.affiliation: Mr. West is Principal Consultant with Innovum Research, Las Vegas, Nevada (was with ePharmaSolutions, Plymouth Meeting, Pennsylvania, at the writing of this article); Dr. Daniel is Senior Vice President, Chief Medical Director, Bracket Global LLC and is with the Department of Psychiatry and Behavioral Sciences, George Washington University, McLean, Virginia; Dr. Opler is Chief Scientific Officer, Founder, ProPhase LLC, New York, New York; Dr. Wise-Rankovic is Vice President, CNS Clinical Development, INC Research, Raleigh, North Carolina; and Dr. Kalali is Professor of Psychiatry, University of California, San Diego, and Vice President, Global Head, Neuroscience Center of Excellence, Quintiles, San Diego, California.
authors.forename: David G
authors.initials: DG
authors.lastname: Daniel
authors.affiliation: Mr. West is Principal Consultant with Innovum Research, Las Vegas, Nevada (was with ePharmaSolutions, Plymouth Meeting, Pennsylvania, at the writing of this article); Dr. Daniel is Senior Vice President, Chief Medical Director, Bracket Global LLC and is with the Department of Psychiatry and Behavioral Sciences, George Washington University, McLean, Virginia; Dr. Opler is Chief Scientific Officer, Founder, ProPhase LLC, New York, New York; Dr. Wise-Rankovic is Vice President, CNS Clinical Development, INC Research, Raleigh, North Carolina; and Dr. Kalali is Professor of Psychiatry, University of California, San Diego, and Vice President, Global Head, Neuroscience Center of Excellence, Quintiles, San Diego, California.
authors.forename: Mark
authors.initials: M
authors.lastname: Opler
authors.affiliation: Mr. West is Principal Consultant with Innovum Research, Las Vegas, Nevada (was with ePharmaSolutions, Plymouth Meeting, Pennsylvania, at the writing of this article); Dr. Daniel is Senior Vice President, Chief Medical Director, Bracket Global LLC and is with the Department of Psychiatry and Behavioral Sciences, George Washington University, McLean, Virginia; Dr. Opler is Chief Scientific Officer, Founder, ProPhase LLC, New York, New York; Dr. Wise-Rankovic is Vice President, CNS Clinical Development, INC Research, Raleigh, North Carolina; and Dr. Kalali is Professor of Psychiatry, University of California, San Diego, and Vice President, Global Head, Neuroscience Center of Excellence, Quintiles, San Diego, California.
authors.forename: Alexandria
authors.initials: A
authors.lastname: Wise-Rankovic
authors.affiliation: Mr. West is Principal Consultant with Innovum Research, Las Vegas, Nevada (was with ePharmaSolutions, Plymouth Meeting, Pennsylvania, at the writing of this article); Dr. Daniel is Senior Vice President, Chief Medical Director, Bracket Global LLC and is with the Department of Psychiatry and Behavioral Sciences, George Washington University, McLean, Virginia; Dr. Opler is Chief Scientific Officer, Founder, ProPhase LLC, New York, New York; Dr. Wise-Rankovic is Vice President, CNS Clinical Development, INC Research, Raleigh, North Carolina; and Dr. Kalali is Professor of Psychiatry, University of California, San Diego, and Vice President, Global Head, Neuroscience Center of Excellence, Quintiles, San Diego, California.
authors.forename: Amir
authors.initials: A
authors.lastname: Kalali
keywords: CNS; certification; clinical research; guidelines; rater; rating scales; recommendations; training; training methodology