Questionnaire Structure Information
The questionnaire was divided into eight sections. The questionnaire designed based on the literature review and formulated using Likert scale.
Section I
Demographics: This section covers the age, gender, experience and designation (five questions).
Section II
Factors facilitate QMS implementation: This section comprises of 10 items that covers the factors that facilitate implementation e.g., ‘…..a sense of trust’, ….development of goal setting’ etc.
Section III
Effect of the quality Management System on the Practical Work: A comprised of 20 items that examine the benefits of QMS at work level including concrete efforts and general effects.
Section IV Quality Planning:
A 10 item scale that comprised of several items on quality planning including SOP creation, protocol, assessment and selection etc.
Section V: Quality Assurance:
A 12 items scale on quality assurance including adverse event reporting, ethical committee, data queries etc.
Section VI: Quality Control:
A 5 item on quality control including data management and storage.
Section VII: Quality Improvement:
Five item scales focused on audit system.
5-point Likert scale was used to assign scores and the participants were asked to select options 1 to 5 where 1 represents strongly disagrees and 5 represents strongly agree.
Questionnaire was designed using Google survey doc and link was sent to the participants through emails. In addition, face book and LinkedIn was to send the links. Since researcher is working in one of the clinical trial industry, it was easier to access the potential participants. In addition, participants for the study were chosen from various sources including ‘http://in.linkedin.com/title/clinical+investigator’.
