Table 1 Description of parameters regarding the detection of adverse events
National sponsors | International sponsors | |||
|---|---|---|---|---|
Indicator | Observation | Yes (%) | Yes (%) | Total (%) |
Persons assigned to detect adverse events | 104 | 4 (3.8) | 37 (35.6) | 41 (39.4) |
Defined a minor adverse event | 104 | 4 (3.8) | 53 (51.0) | 57 (54.8) |
Defined a serious adverse event | 104 | 4 (3.8) | 53 (51.0) | 57 (54.8) |
Indicated a time frame to detect adverse events | 104 | 3 (2.9) | 41 (39.4) | 44 (42.3) |
Described a Procedure for detecting adverse events | 104 | 2 (1.9) | 31 (29.8) | 33 (31.7) |
Case Report Form | 96 | 4 (3.8) | 35 (33.7) | 39 (37.5) |