| CTRI Number |
CTRI/2017/07/009066 [Registered on: 17/07/2017] Trial Registered Prospectively |
| Last Modified On: |
15/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Survey of Public Knowledge and perceptions about clinical research in Mumbai |
|
Scientific Title of Study
|
Survey of Public Knowledge and Perceptions about clinical research in Mumbai. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr urmila Thatte |
| Designation |
Professor & head |
| Affiliation |
sethgsmcandkemh |
| Address |
Department of Clinical Pharmacology, First floor, New Multistorey Building Seth GSMC and KEMH,Parel,Mumbai
NA
NA
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224133767 |
| Fax |
24112871 |
| Email |
urmilathatte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drurmila Thatte |
| Designation |
professor and head |
| Affiliation |
sethgsmcandkemh |
| Address |
First floor new multistorey building seth gsmc and kemh parel Mumbai
NA
NA
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224133767 |
| Fax |
24112871 |
| Email |
urmilathatte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MsBrinal Figer |
| Designation |
Ph.D Scholar |
| Affiliation |
Seth GSMC and KEMH |
| Address |
First floor new multistorey building Seth GSMC and KEM Hospital parel Mumbai
NA
NA
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224133767 |
| Fax |
24112871 |
| Email |
brinz19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Reserach society, Seth GSMC and KEMH,Parel,Mumbai |
|
|
Primary Sponsor
|
| Name |
Seth GSMC and KEM Hospital |
| Address |
Seth GSMC and KEM Hospital,Acharya Donde Marg,Parel,Mumbai |
| Type of Sponsor |
Government medical college |
|
|
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 urmila thatte |
Seth GSMC and KEM Hospital |
first floor new multistorey building parel Mumbai
Mumbai
MAHARASHTRA |
02224133767
2224112871
urmilathatte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutionalethicscommittee2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult healthy participants. |
|
| ExclusionCriteria |
| Details |
peoplewhoarenotmumbairesidents |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine extent of awareness about clinical research among the people of Mumbai |
to determine extent of awareness about clinical research among the people of mumbai |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| toassessextentofmisinformationaboutclinicalresearchamongpeopleofmumbai |
nil |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
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)
|
29/07/2017 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a cross Sectional questionnaire based study to assess the extent of awareness about clinical research among the people of mumbai. |