Table 1.

Summary of the severity, occurrence, and detection scores and RPN by six selected core processes

Core process	No of potential failure modes	Score			RPN
		Severity	Occurrence	Detection
Obtaining informed consent	32	7.11±2.34	2.71±1.85	3.48±2.05	81.24±88.89
Screening and patient identification/enrolment	16	6.42±1.98	2.39±0.95	3.10±1.40	51.48±31.46
Site personnel training	8	7.80±1.47	4.80±2.24	5.40±1.35	195.25±82.42
Document management including source documents and essential documents	23	7.40±1.27	3.72±2.16	5.09±1.65	127.29±70.48
Safety management such as reporting SAE and SUSARs	25	6.76±2.27	2.43±1.17	4.63±0.95	69.04±28.38
Inspection readiness	10	5.63±1.89	1.95±1.18	3.53±2.06	37.53±25.46
Total	114	6.92±2.08	2.88±1.81	4.16±1.83	86.07±75.12

Note: Mean ± standard deviation is displayed.

Abbreviations: RPN, risk priority number; SAE, serious adverse event; SUSAR, suspected unexpected serious adverse reaction.