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Evaluation of Knowledge and Awareness of Patients Safety, Regulatory guidance and Quality Assurance in Clinical Trials among Medical and Paramedical Students

Assessment of Knowledge and Awareness of Patients Safety, Regulatory Compliance and Quality Assurance in Clinical Trials among Medical and Paramedical Students - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/02/081015
Enrollment
400
Registered
2025-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

PARVATHA RAJA KUMARAN
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Above 18 years who provides Informed Consent b) Final year UG & PG medical graduates c) Final year UG & PG Pharmacy & Nursing

Exclusion criteria

Exclusion criteria: a) Who does not provides Informed consent b) Incomplete questionnaire

Design outcomes

Primary

MeasureTime frame
1.Proportion of students demonstrating adequate knowledge of clinical trial components, determined by achieving a predefined passing score on a validated structured assessment. 2.Mean knowledge score of medical and paramedical students, categorized into predefined levels based on score distribution. 3.Comparison of mean knowledge scores between medical and paramedical students using appropriate statistical tests to determine significant differences.Timepoint: After obtaining Informed Consent, Single point of time—

Secondary

MeasureTime frame
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.Timepoint: After obtaining Informed Consent -Single point of time—

Countries

India

Contacts

Public Contactnayak deeksha dayanand

SRM Medical College Hospital and Research Centre

vsprk98@gmail.com9566392461

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026