Table 3.
Baseline characteristics of protocols reviewed by screening audit
| Characteristics | N(%) |
|---|---|
| Phase | |
| Phase 1, 1/2 | 3 (0.6) |
| Phase 2 | 36 (7.8) |
| Phase 2/3 | 2 (0.4) |
| Phase 3 | 13 (2.8) |
| Phase 4 | 40 (8.7) |
| Post-market surveillance | 1 (0.2) |
| Medical device | 6 (1.3) |
| Non-phase clinical research | 361 (78.1) |
| Total | 462 (100) |
| Multicenter | |
| Single center | 281(60.8) |
| Domestic multicenter | 162(35.1) |
| International multicenter | 19(4.1) |
| Total | 462 (100) |
| Department of principle investigatorc | |
| Clinical department I | 179(38.7) |
| Clinical department II | 45(9.7) |
| Clinical department III | 123(26.6) |
| Supportive departments | 101(21.9) |
| Basic Science departments | 14(3.0) |
| Total | 462 (100) |
| Risk Levela | |
| Level I | 263(56.9) |
| Level II | 152(32.9) |
| Level III | 31(6.7) |
| Level IV | 1(0.2) |
| Undeterminatedb | 15(3.2) |
| Total | 462 (100) |
| Responsible entity | |
| Investigator initiated | 455(98.5) |
| Sponsor initiated | 7(1.5) |
| Total | 462 (100) |
aLevel 1=minimal risk, Level 2=minor increase over minimal risk, Level 3= Possible significant sequelae, must be transient, Level 4= could result in death or irreversible, debilitating damage, or major unknowns with respect to the intervention
bProtocols reviewed by the IRB prior to 2007 did not have their risk level determined
cClinical department I (Department of Internal Medicine including Oncology, Gastroenterology, Rheumatology, Endocrinology, Nephrology, Cardiology, Hematology, Pulmonology); Clinical department II (Department of Surgery including General surgery, Transplantation, Orthopedic surgery, Cardiovascular surgery, Neurosurgery, Plastic surgery); Clinical department III (Family medicine, Urology, Obstetrics and Gynecology, Pediatrics, Neurology, ophthalmology, Emergency medicine, otorhinolaryngology, Rehabilitation, Psychiatry, Dermatology); Supportive departments (Pathology, Laboratory medicine, Anesthesiology and Pain Medicine, Radiology, Nuclear medicine, Radiation oncology); Basic Science departments (Forensic Science, Microbiology, Physiology, Public health, Preventive medicine, Pharmacology)