Assessment of Knowledge and Awareness of Patients Safety, Regulatory Compliance and Quality Assurance in Clinical Trials among Medical and Paramedical Students
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- 1.Proportion of students demonstrating adequate knowledge of clinical trial components, determined by achieving a predefined passing score on a validated structured assessment.
研究概览
简要总结
This study aims to assess the knowledge and understanding of clinical trials (CTs) among final-year undergraduate (UG) and postgraduate (PG) medical, pharmacy, and nursing students through a questionnaire-based survey. Despite their involvement in CTs, students often lack formal training in regulatory and ethical aspects, highlighting a knowledge gap. The study will use a validated questionnaire covering ten CT domains, with responses analyzed using descriptive and inferential statistics. Findings will help evaluate the impact of prior exposure to CTs and emphasize the need for foundational CT training
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Above 18 years who provides Informed Consent b) Final year UG & PG medical graduates c) Final year UG & PG Pharmacy & Nursing.
排除标准
- •a) Who does not provides Informed consent b) Incomplete questionnaire.
结局指标
主要结局
1.Proportion of students demonstrating adequate knowledge of clinical trial components, determined by achieving a predefined passing score on a validated structured assessment.
时间窗: After obtaining Informed Consent, Single point of time
2.Mean knowledge score of medical and paramedical students, categorized into predefined levels based on score distribution.
时间窗: After obtaining Informed Consent, Single point of time
3. Comparison of mean knowledge scores between medical and paramedical students using appropriate statistical tests to determine significant differences.
时间窗: After obtaining Informed Consent, Single point of time
次要结局
- 1.Analysis of knowledge gaps in key areas such as patient safety, regulatory compliance, & quality assurance, based on incorrect responses & self-reported uncertainty in the structured assessment.(2.Development of targeted educational interventions based on identified knowledge gaps to enhance awareness & understanding of clinical trial components.)
研究者
Dr Satyajit Mohapatra
SRM Medical College Hospital and Research Centre