| CTRI Number |
CTRI/2025/02/081015 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive Study (Survey) |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Knowledge and Awareness of Patients Safety, Regulatory guidance and Quality Assurance in Clinical Trials among Medical and Paramedical Students |
|
Scientific Title of Study
|
Assessment of Knowledge and Awareness of Patients Safety, Regulatory Compliance and Quality Assurance in Clinical Trials among Medical and Paramedical Students |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyajit Mohapatra |
| Designation |
Director |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room No. 2, SRM CENTRE FOR CLINICAL TRIALS AND RESEARCH, Thrid Floor, E block Extension, SRM Medical College Hospital and Research Centre, Kattankulathur Campus, Tamil nadu, India 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09791161626 |
| Fax |
|
| Email |
satyajitmp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parvatha Raja Kumaran V S |
| Designation |
Research Scientist 1 |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room No. 17,
SRM CENTRE FOR CLINICAL TRIALS AND RESEARCH, Thrid Floor, E block Extension, SRM Medical College Hospital and Research Centre, Kattankulathur Campus Tamil nadu, India 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9566392461 |
| Fax |
|
| Email |
vsprk98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
nayak deeksha dayanand |
| Designation |
Research Scientist 2 |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room No. 17,
SRM CENTRE FOR CLINICAL TRIALS AND RESEARCH, Thrid Floor, E block Extension, SRM Medical College Hospital and Research Centre, Kattankulathur Campus Tamil nadu, India 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9739061639 |
| Fax |
|
| Email |
nayakdeeksha1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM CENTRE FOR CLINICAL TRIALS AND RESEARCH, Thrid Floor, E block Extension, SRM Medical College Hospital and Research Centre, Kattankulathur Campus, Tamil Nadu, India - 603203 |
|
|
Primary Sponsor
|
| Name |
PARVATHA RAJA KUMARAN |
| Address |
Room No. 17, SRM CENTRE FOR CLINICAL TRIALS AND RESEARCH,Third floor, E-block extension, SRM Medical College Hospital and Research Centre, Kattankulathur Campus, Tamil nadu, India-603203 |
| Type of Sponsor |
Other [SELF FUNDING] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Satyajit Mohapatra |
SRM Medical College Hospital and Research Centre |
SRM CENTRE FOR CLINICAL TRIALS AND RESEARCH, E Block extension, Third floor, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Kattankaluthur TN 603203
Kancheepuram
TAMIL NADU |
9791161626
satyajitmp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRM College Hospital and Research Centre,Tamil Nadu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
na |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
a) Above 18 years who provides Informed Consent
b) Final year UG & PG medical graduates
c) Final year UG & PG Pharmacy & Nursing
|
|
| ExclusionCriteria |
| Details |
a) Who does not provides Informed consent
b) Incomplete questionnaire |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
After obtaining Informed Consent, Single point of time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
After obtaining Informed Consent -Single point of time |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 |