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2015
May
I
INDIAN CLINICAL RESEARCH STRIGENT REGULATION
INDIAN CLINICAL RESEARCH STRIGENT REGULATION
IMPACT OF NEW REGULATIONS ON CLINICAL TRIALS IN INDIA: A SURVEY
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Exit Survey
Dear Participants,
This survey is being conducted as a part of the special project for Master’s degree, by Ms. Nisha Devi Muthu Krishnan from Eastern Michigan University. You are invited to participate in a survey about "Impact of new regulations on clinical trials in India".
The aim of this survey is to evaluate the impact, positive or negative, if any due to the promulgation of new clinical trial regulations in the period 2013 to 2015.
In this survey, clinical trial professionals from various organizations in India will be requested to provide their opinion on a number of questions related to the topic.
It will take approximately 5-7 minutes of your time to complete the questionnaire, and your participation in this study is completely voluntary. There are no foreseeable risks associated with this project.
Your survey responses will be strictly confidential, we will not collect your name and other identifiers, and data from this research will be reported only in aggregate.
At the outset I thank you very much for your time and support. Please start with the survey now by clicking on the
Continue button below.
I Agree
*
1) Which of the following best describes your current work setting?
Sponsor
CRO
Ethics Committee
Other Trial Site
*
2) Have you attended any training on new Clinical Research regulations in India?
Yes
No
*
3) How will you rate your knowledge on new Indian Clinical Research Regulations?
Poor
Average
Excellent
*
4) In general, how satisfied you are with the new regulations of Indian Clinical research after 2013?
Completely unsatisfied
Somewhat unsatisfied
Neither satisfied nor unsatisfied
Somewhat satisfied
Completely satisfied
*
5) Do you find any difference in number of new trials initiated after new regulations compared to the years before:
Yes
No
Not for me
*
6) The new compensation formula is necessary for the volunteers involved in clinical trial!
Completely disagree
Somewhat disagree
Neutral
Somewhat agree
Completely agree
*
7) Audio-Video recording of informed consent of volunteers is necessary!
Completely disagree
Somewhat disagree
Neutral
Somewhat agree
Completely agree
*
8) Do you think is their any impact on
patient enrollment
after the new regulations?
Yes, High Impact
Yes, Moderate
Yes, but minor
No, not at all
*
9) Do you think is there any
economic impact
on India due to new regulations?
Yes, High Impact
Yes, Moderate
Yes, but minor
No, not at all
Not for me
*
10) In general, how will you support on easing the clinical trial norms in future?
Strongly disagree
Disagree
Neither agree nor disagree
Agree
Strongly agree
Impact of new clinical trial regulations in India
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