The New Drugs and Clinical Trial Rules, 2019 India: research professionals perception and perspectives
Dear Sir/Madam,

My name is Vishal Vennu, and I am a doctoral student of clinical research program. I am kindly requesting your participation in a doctoral research study that I am conducting titled: “A survey of research professionals’ awareness and opinions regarding the new drugs and clinical trial rules, 2019 India.” The purpose of this survey is to investigate the present awareness and opinions of various research professionals (investigators, member of ethics committee, assistant, coordinators, associates, and managers) who have engaged in clinical trials regarding the new drugs and clinical trial rules, 2019 India released by the Ministry of Health and Family Welfare on March 19, 2019.

The proposed project survey questionnaires were validated in previous research, and those researchers granted permission to use in this project with slightly modification. Participation in this survey is entirely voluntary and anonymous. Therefore, it does not require you to provide your name or any other identifying information, except age and gender. Your participation in the research will be of great importance to assess the present awareness or opinion regarding the new rules, 2019.

Thank you for your time and participation.

Sincerely,
Vishal Vennu, B.Sc, M.Sc, Doctoral Student.

1) Please indicate your age *
2) Please indicate your gender *
3) In which region of India do you live? *
4) What is your role in clinical trial or research? *
5) If you are a member of ethics committee, What is your role ?
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6) Are you aware of the New Drug and Clinical Trial Rules, 2019 India? *
7) Are your manager and the clinical staff involved in clinical trials aware of the new rules, 2019? *
8) If so, how aware do you think they are of the implications that this might have on clinical trials? (from 1=not at all to 5= a lot) *
9) Would it be useful to share this issue with the Principal Investigators and sub Investigators in your department to understand what the issues there might be at all levels and to understand their level of awareness and opinions? *
10) If you are not aware of the New Drugs and Clinical Trial Rules, 2019 India, do you think it would be useful to have information about it? *
11) What do you think the best ways to keep up to date? (answer any that apply) *
12) What are the changes have new rules, 2019 brought to the previously published Drugs and Cosmetics Rules, 1945? (multiple choice allowed) *
Required
13) Which issue, among the following, do you think it has not been treated with adequate clarity? (answer any that apply) (multiple choice allowed) *
Required
14) Do you think that the new rules have not treated some issues enough? *
15) What do you think will be the most important consequences of the new rules? *
16) Do you think that the adoption of the new rules will change your way of working? *
17) Do you think that Ethics Committee staff and/or scientific boards are ready to face the new challenges of the new rules, 2019? *
18) Is the new rule on reducing timeline of the clinical trial of new drugs appropriate and adequate? *
19) Is the new rule on phase IV appropriate and adequate? *
20) Is the new rule regarding free post trial drug access appropriate and adequate? *
21) Is new rule on clinical trial approval validity appropriate and adequate? *
22) What you thing about the new rule on welcoming equality is appropriate and adequate? *
23) The new rules, 2019 on serious adverse event and compensation are appropriate and adequate concerning what has to be reported, to whom, how and provide the timelines for the same? *
24) What kind of clinical trials will the new rules bring most change to? *
25) As a research professional, what is your opinion on the new rules, 2019? *
26) What is your general opinion about the new rules, 2019 India? *
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