‘Screening audit’ as a quality assurance tool in good clinical practice compliant research environments

BMC Medical Ethics

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 investigator^c
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 Level^a
Level I	263(56.9)
Level II	152(32.9)
Level III	31(6.7)
Level IV	1(0.2)
Undeterminated^b	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)

ISSN: 1472-6939