• Title/Summary/Keyword: Risk Checklist

Search Result 225, Processing Time 0.025 seconds

Analysis of Indicated Points and Main Factors Affecting the Quality of Clinical Research for the Development of Internal Audit Tools (자체점검 도구 개발을 위한 지적사항 및 임상연구의 품질에 작용하는 요인 분석)

  • Hye Yun Jang;Jung-Hee Jang;Yoon Jin Lee
    • The Journal of KAIRB
    • /
    • v.5 no.1
    • /
    • pp.14-20
    • /
    • 2023
  • Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

  • PDF

Malaria Risk Factors in Kaligesing, Purworejo District, Central Java Province, Indonesia: A Case-control Study

  • Cahyaningrum, Pratiwi;Sulistyawati, Sulistyawati
    • Journal of Preventive Medicine and Public Health
    • /
    • v.51 no.3
    • /
    • pp.148-153
    • /
    • 2018
  • Objectives: Malaria remains a public health concern worldwide, including Indonesia. Purworejo is a district in which endemic of malaria, they have re-setup to entering malaria elimination in 2021. Accordingly, actions must be taken to accelerate and guaranty that the goal will reach based on an understanding of the risk factors for malaria. Thus, we analysed malaria risk factors based on human and housing conditions in Kaligesing, Purworejo, Indonesia. Methods: A case-control study was carried out in Kaligesing subdistrict, Purworejo, Indonesia in July to August 2017. A structured questionnaire and checklist were used to collect data from 96 participants, who consisted of 48 controls and 48 cases. Univariate, bivariate, and multivariate analyses were performed. Results: Bivariate analysis found that education level, the presence of a cattle cage within 100 m of the house, not sleeping under a bednet the previous night, and not closing the doors and windows from 6 p.m. to 5 a.m. were significantly ($p{\leq}0.25$) associated with malaria. Of these factors, only not sleeping under a bednet the previous night and not closing the doors and windows from 6 p.m. to 5 a.m. were significantly associated with malaria. Conclusions: The findings of this study demonstrate that potential risk factor for Malaria should be paid of attention all the time, particularly for an area which is targeting Malaria elimination.

The Effects of Risk Factors and Protective Factors on Children's Problem Behavior: The Theoretical Process Model (아동의 문제행동에 영향을 미치는 위기요인과 보호요인의 이론적 과정모델)

  • Lee, Seon Kyung;Lee, Jae Yeon
    • Korean Journal of Child Studies
    • /
    • v.19 no.2
    • /
    • pp.49-64
    • /
    • 1998
  • The theoretical process model was used to study problem behavior of children growing up at-risk. A sample of 339 children living in at-risk families were selected from among 2, 134 children in grades 4, 5, and 6 of five elementary schools in Seoul. The instruments were five risk factor scales and four protective factor scales. The Child Behavior Checklist was also used. The results of the hypothetical model of children at-risk showed that the factor of socioeconomic status led to positive child rearing attitudes in mothers, which is turn influenced children's problem behavior indirectly. In contrast, stressful life events and mother's depression influenced children's problem behavior directly. However, negative family functioning, marital discord and father's depression did not influence mother's child rearing attitudes or children's problem behavior. Mother's child rearing attitudes directly influenced children's social competence and academic achievement and indirectly influenced their problem behavior. Academic achievement did not influence problem behavior directly, but social competence influenced it directly. Mother's child rearing attitude was the most significant factor affecting children's adaptation.

  • PDF

Effects of nonpharmacological interventions on the psychological health of high-risk pregnant women: a systematic review and meta-analysis

  • Yoo, Hyeji;Ahn, Sukhee
    • Women's Health Nursing
    • /
    • v.27 no.3
    • /
    • pp.180-195
    • /
    • 2021
  • Purpose: This study aimed to summarize the current evidence on the effects of nonpharmacological interventions on psychological health outcomes for women with high-risk pregnancies due to conditions such as preeclampsia, gestational diabetes, or preterm labor. Methods: The following databases were searched from January 2000 to December 2020: PubMed, Ovid Embase, CINAHL, Web of Science, DBpia, RISS, and KISS. Two investigators independently reviewed and selected articles according to the inclusion/exclusion criteria. RoB 2 and the ROBINS-I checklist were used to evaluate study quality. Results: Twenty-nine studies with a combined total of 1,806 pregnant women were included in the systematic review and meta-analysis. Psychological health improvements were found in women with preeclampsia (Hedges' g=-0.67; 95% confidence interval [CI], -0.91 to -0.44), gestational diabetes (Hedges' g=-0.38; 95% CI, -0.54 to -0.12), and preterm labor (Hedges' g=-0.73; 95% CI, -1.00 to -0.46). The funnel plot was slightly asymmetrical, but the fail-safe N value and the trim-and-fill method showed no publication bias. Conclusion: Nonpharmacological interventions for women with high-risk pregnancies due to conditions such as preeclampsia, gestational diabetes, and preterm labor can improve psychological parameters such as anxiety, stress, and depression. Nurses can play a pivotal role in the nursing management of pregnant women with high-risk conditions and apply various types of nonpharmacological interventions to meet their needs in uncertain and anxious times during pregnancy.

Risk-based Safety Impact Assessment for Construction Projects (위험도 접근방법에 의한 건설사업 안전영향평가방안에 관한 연구)

  • Choi Hyun-Ho;Jung Pyung-Ki;Seo Jong-Won;Choi Ook
    • Proceedings of the Korean Institute Of Construction Engineering and Management
    • /
    • 2004.11a
    • /
    • pp.504-509
    • /
    • 2004
  • Safety assessment of construction projects may be affected by various factors such as types and scale of projects, construction methods, procedure, climactic, and site conditions etc. Presently, in planning and design phases, designers are still often uncertain of their responsibilities, l3i]I information and training of safety. Therefore, designers are still failing to exploit the potential that have to eliminate and reduce risks on site. In this study, the concepts of safety impact assessment is introduced in order to derive the performing design for safety in design phase. For this purpose, a framework for safety impact assessment model using risk-based approach for construction projects is suggested. The suggested model includes of information survey and scenarios, classification of safety impact factors occurred by design and construction, and quantitative estimation of magnitude and frequency. Moreover, the checklist which is enable to identify relationship between safety impact factors and design factors is developed and the methodology of safety impact assessment model using risk-based approach is also proposed.

  • PDF

Risk analysis of checklist for efficient web vulnerability inspection (효율적인 웹 취약점 점검을 위한 점검항목의 위험도 분석)

  • Lee, Hyun-A
    • Proceedings of the Korea Information Processing Society Conference
    • /
    • 2018.05a
    • /
    • pp.126-128
    • /
    • 2018
  • 웹 해킹 사고 건수와 피해규모가 매년 증가하고 있다. 해킹사고의 대부분이 웹을 통해 발생하고 있으며 웹 취약점 점검을 통해 사전에 예방할 수 있지만 인력과 예산 부족으로 주기적인 점검이 어려운 것이 현실이다. 본 연구에서는 효율적인 웹 점검을 위해 공격가능성을 바탕으로 점검 항목의 위험도를 분석하고 향후 지속되어야 할 연구 방향을 제시한다.

A Study on the Improvement of Risk Assessment Method in Laboratory (연구실 위험성평가방법 개선에 관한 연구)

  • Kim, Soo-Tae
    • Journal of the Society of Disaster Information
    • /
    • v.18 no.3
    • /
    • pp.444-456
    • /
    • 2022
  • Purpose: Laboratories require Preliminary Risk Analysis of Hazard Factors, but there are many laboratories that do not. For the purpose of securing the safety of the laboratory, it is intended to find improvements so that the Risk Assessment can be easily applied. Method: Research papers and data from the Laboratory Safety Management Survey Report by the Ministry of Science and ICT were used. The study was conducted by comparing Preliminary Risk Analysis of Hazard Factors and Risk Assessment under the Occopational Safety and Health Act. Result: A technique for Risk Assessment of a laboratory was proposed. When Risk Assessment of the laboratory, a method was proposed to estimate the size of the possibility(frequency) and severity(intensity). Conclusion: For easy application in the laboratory, a checklist-type Risk Assessment technique was presented and actual evaluation was conducted. It is expected that the laboratory will improve through Risk Assessment to help prevent safety accidents.

Development of Standard Risk Indicators for the Prevention of Serious Accidents in Mobile Crane Operations (Focused on Construction Industry) (이동식크레인 작업의 중대재해예방을 위한 표준 리스크 평가 지수 개발 (건설업을 중심으로))

  • Jonggook Choi;Jongwoo Lee
    • Journal of the Society of Disaster Information
    • /
    • v.19 no.3
    • /
    • pp.719-728
    • /
    • 2023
  • Purpose: Mobile cranes are machines that contribute to high mortality, and the High Risk Factor (SIF) information, which analyzed 2,574 accidental deaths in the construction industry in the past 6 years (2016~2021), resulted in a total of 61 mobile crane accidents. Despite safety measures in the field, it is not used properly. In this study, we present standard risk assessment indicators that contribute to accident prevention. Method: Through expert interviews, fatal accident case analysis, field analysis, and literature research, we present the standard risk assessment index method of the 4M risk assessment method. Result: As a result of analyzing the risk assessment of eight sites, it was concluded that it cannot make a significant contribution to disaster prevention and should be applied as an improvement measure of the Standard Risk Assessment Index Law. Conclusion: Switching to the standard risk assessment index method at construction sites has been proposed to make it easier for health and safety personnel and workers to use, contributing to the reduction of accidents.

Risk Assessment of Physical Hazards in Greek Hospitals Combining Staff's Perception, Experts' Evaluation and Objective Measurements

  • Tziaferi, Styliani Gewrgios;Sourtzi, Panayiota;Kalokairinou, Athina;Sgourou, Evi;Koumoulas, Emmanouel;Velonakis, Emmanouel
    • Safety and Health at Work
    • /
    • v.2 no.3
    • /
    • pp.260-272
    • /
    • 2011
  • Objectives: The promotion of health and safety (H&S) awareness among hospital staff can be applied through various methods. The aim of this study was to assess the risk level of physical hazards in the hospital sector by combining workers' perception, experts' evaluation and objective measurements. Methods: A cross-sectional study was designed using multiple triangulation. Hospital staff (n = 447) filled in an H&S questionnaire in a general hospital in Athens and an oncology one in Thessaloniki. Experts observed and filled in a checklist on H&S in the various departments of the two hospitals. Lighting, noise and microclimate measurements were performed. Results: The staff's perception of risk was higher than that of the experts in many cases. The measured risk levels were low to medium. In cases of high-risk noise and lighting, staff and experts agreed. Staff's perception of risk was influenced by hospital's department, hospital's service, years of working experience and level of education. Therefore, these factors should be taken into account in future studies aimed at increasing the participation of hospital workers. Conclusion: This study confirmed the usefulness of staff participation in the risk assessment process, despite the tendency for staff to overestimate the risk level of physical hazards. The combination of combining staff perception, experts' evaluation and objective measures in the risk assessment process increases the efficiency of risk management in the hospital environment and the enforcement of relevant legislation.

Development of Runway Incursion Risk Assessment Checklist (활주로 침범 위험 분석 체크리스트 개발)

  • Maeng, Sung-Kyu;Jung, Yoon-Sik;Choi, Jin-Kook;Kwon, Bo-Hun
    • Journal of the Korean Society for Aviation and Aeronautics
    • /
    • v.20 no.1
    • /
    • pp.46-54
    • /
    • 2012
  • One major safety issue of surface operations is the occurrence of runway incursions. Runway incursions are the consequence of multiple operational and/or environmental factors. Human error is known to contribute to almost every runway incursion. One major contributing factor for runway incursion is crew's lack of situational awareness during airport surface operations, induced by weather considerations, by complex airport factors or by crew technique itself; it is also caused by ATC issues. Various airport factors may affect pilot situational awareness, distract the crew, or lead to crew confusion. The recommendations to avoid runway incursions are manifold; Proper Crew's CRM/TEM skills, adequate communication technique, proper knowledge of airport surface markings, lights and signs and preparation of preparation of expected taxi out/in routing. Also runway incursion risk assessment on specific airport before flight may lead to aware of risk level and contribute to prevent runway incursion.