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. 2018 Jun 18;26(2):86–92. doi: 10.12793/tcp.2018.26.2.86

Table 3. The requirements for the future CTMS (Q8~Q9).

Hospital Pharma-ceutical company CRO IT-related company Others Total
N (%) N (%) N (%) N (%) N (%) N (%)
Q8. Choose functions you think it should be included in a future CTMS? (THREE multiple responses)
Recruitment site for clinical trial subjects 59 (24) 7 (8) 19 (13) 3 (38) 14 (27) 102 (19)
Confirmation of participation history of subjects in hospital or other hospitals 99 (41) 26 (31) 31 (22) 4 (50) 19 (37) 179 (34)
Acquisition of electronic consent forms 89 (37) 23 (27) 42 (29) 2 (25) 10 (20) 166 (31)
Clinical trial-related document management including standard operating procedures and protocols 65 (27) 21 (25) 48 (33) 3 (38) 16 (31) 153 (29)
Management of project schedule, overseeing the subject enrollment status 116 (48) 38 (45) 49 (34) 1 (13) 21 (41) 225 (42)
Establishment and management of clinical trial budget and estimate, or remittance of research funds 39 (16) 32 (38) 41 (28) 2 (25) 9 (18) 123 (23)
Link to research and investigator registration sites (such as Clinicaltrials.gov, KRI) 30 (12) 17 (20) 21 (15) 3 (38) 8 (16) 79 (15)
Systemic link to electronic medical records including prescription and laboratory test results 113 (47) 33 (39) 63 (44) 0 (0) 11 (22) 220 (41)
Electronic data capture (EDC, eCRF) 41 (17) 15 (18) 28 (19) 0 (0) 4 (8) 88 (17)
Adverse events report 32 (13) 11 (13) 32 (22) 2 (25) 11 (22) 88 (17)
Reservation for a monitoring room, management of monitoring schedule and reporting the results 10 (4) 8 (9) 18 (13) 2 (25) 10 (20) 48 (9)
Management of the investigator status at each clinical trial center 22 (9) 19 (22) 29 (20) 1 (13) 7 (14) 78 (15)
Education management site for clinical trials (offline/online) 14 (6) 5 (6) 11 (8) 1 (13) 13 (25) 44 (8)
* p < 0.001