Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access
Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc
Journal website http://www.jocmr.org

Original Article

Volume 10, Number 12, December 2018, pages 877-882

Present Status and Perspectives on Future Roles of Japanese Clinical Research Coordinators

Tables

Table 1. Respondent Characteristics
 
Number (%)
Respondents (n = 69)
Gender
  Male11 (15.9)
  Female58 (84.1)
Age
  20 - 298 (11.6)
  30 - 3924 (34.8)
  40 - 4920 (29.0)
  > 5017 (24.6)
Basic qualifications
  Medical doctor4 (5.8)
  Pharmacist7 (10.1)
  Nurse26 (37.7)
  Medical technologist14 (20.3)
  Clinical nutritionist4 (5.8)
  No medical qualifications14 (20.3)
Affiliations
  Medical institution50 (72.5)
  Contract research organization1 (1.4)
  Site management organization18 (26.1)
  Pharmaceutical company0
  Others0

 

Table 2. Field and Total Length of Main Engagement
 
Number (%)
Respondents (n = 69)
Field of main engagement
  Support and management68 (98.6)
  Investigator of registration trials1 (1.4)
  Investigator of clinical research0
  Not involved0
  Others0
Total length of main engagement
  < 6 months8 (11.6)
  6 - 12 months2 (2.9)
  1 - 5 years31 (44.9)
  ≥ 5 years28 (40.6)

 

Table 3. Main Area and Roles of Involvement
 
Number (%)
Respondents (n = 69)
Main area of involvement
  Industry-initiated registration trials48 (69.7)
  Investigator-initiated registration trials1 (1.4)
  Industry-initiated clinical research5 (7.2)
  Investigator-initiated clinical research10 (14.5)
  Others0
  No response5 (7.2)
Main roles of involvement
  Conventional activities of a CRC in registration trials41 (59.5)
  Ethics committee support17 (24.7)
  Study planning and/or biostatistics1 (1.4)
  Project management1 (1.4)
  Data management2 (2.9)
  Monitoring and auditing2 (2.9)
  Others0
  No response5 (7.2)

 

Table 4. Perspectives of the Two Groups of Respondents - CRCs and Others - on CRC Involvement as Professionals in Clinical Research Beyond Their Conventional Activity in Industry-Initiated Registration Trials
 
Number (%)
CRCs* (n = 41)Others* (n = 28)Total (n = 69)
“CRCs” and “Others” are designated as those who answered conventional activities of a CRC in registration trials as their main roles, and as those who provided other answers in question Part 2, No. 5, respectively.
Strongly agree9 (22.0)8 (28.6)17 (24.6)
Agree11 (26.8)5 (17.9)16 (23.2)
Neutral7 (17.1)9 (32.0)16 (23.2)
Disagree11 (26.8)4 (14.3)15 (21.7)
Strongly disagree3 (7.3)1 (3.6)4 (5.8)
No response01 (3.6)1 (1.4)