Joint Assessor Certification

OVERVIEW JOINT ASSESSORS FOR TRIALS PERFORMED BY THE PEDIATRIC RHEUMATOLOGY COLLABORATIVE STUDY GROUP (PRCSG) AND THE PEDIATRIC RHEUMATOLOGY INTERNATIONAL TRIALS ORGANISATION (PRINTO)

December 1, 2007

Consistency in joint assessments is of critical importance to the overall validity of clinical trials performed by the PRCSG/PRINTO. The Core Set of Outcome Measures for Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) includes six parameters. Two of the six are directly derived from the joint exam. Accordingly, the PRCSG and PRINTO developed common standardized guidelines used by both networks to certify joint assessors for JIA clinical trials in 2003. These guidelines were revised in 2006 and an overview statement was added December 1, 2007. In all instances, changes have been reviewed and approved by leaders of the PRCSG and PRINTO networks. The current guidelines are shown in Attachment. Both PRCSG and PRINTO require extensive training in pediatric rheumatology to be eligible for membership in either network. It is expected that any person proposed as a joint assessor in a PRCSG/PRINTO trial already would have extensive training in the basics of performing a joint exam as part of this training in pediatric rheumatology. The Coordinating Center for each network maintains a list of certified joint assessors for that network. The mechanism, method of performing a joint exam and method of assessing a joint exam in PRCSG/PRINTO trials has remained stable and uniform. Therefore, the certification of joint assessors is not limited in duration. If however, performance of the joint exam to be performed by the joint assessors changes in any systematic way, e.g. introduction of ultrasound into joint assessment, then all joint assessors will need to be recertified using the new assessment approach. This Overview statement has been reviewed and agreed to by leaders of both the PRCSG and PRINTO as attested by signatures below.


Daniel Lovell, MD, MPH         Alberto Martini, MD

PRCSG Chairman                 PRINTO Chairman


Hermine Brunner, MD            Nicola Ruperto, MD, MPH

PRCSG Scientific Director      PRINTO Senior Scientist