薬理と治療

Abstract

Background Clinical research coordinators（CRCs）in Japan often have to respond flexiblyto changing situations of daily work. Anxiety−provoking stressful situations and factors associatedwith such anxiety were investigated. Relationships between anxiety and various factorssuch as medical qualifications, CRC experience, and CRC certification／accreditation wereanalyzed.Methods A total of 174 currently active CRCs were asked via questionnaire to name workrelatedsituations that caused tension and anxiety during the previous week. Anxiety levelwas measured using the State Trait Anxiety Inventory（STAI）and Visual Analogue Scale（VAS）. Stressful situations were classified into 15 categories, and the relationship of eachcategory to STAI score, VAS level, medical qualifications, CRC experience, and CRC certification／accreditation was analyzed.Results The mean state anxiety level（measured by STAI）was high, and a tendency to behighly anxious was shown in all CRC respondents. Stress and anxiety levels were significantlyhigher in CRCs with 1−2 years’experience than in those with 3−4 years’experience.The most commonly−named stressful situations were“communication with subjects, andschedule management”for pharmacist and nurse CRCs, and“liaison and coordination withinvestigators”for clinical technologist CRCs. CRCs working in Site Management Organization（SMO）named“clinical study pre−commencement duties”significantly more frequently thanCRCs working in medical institutions. State anxiety level was lower in CRCs with CRC certification／accreditation than in those without.Conclusions In CRCs, perceived stressful situation and anxiety depend on medical qualifications,affiliated institution, length of experience, and certification／accreditation. A cooperativeapproach and support systems will reduce anxiety levels.（Jpn Pharmacol Ther 2010；38：69−80）KEY WORDS CRC, Anxiety, Stress