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willing to withdraw. Factor analysis had grouped awareness level into two components
viz.: Information to be taken for participation and Knowledge of approach for study
related concern. Also factor analysis had grouped factor considered into three
components viz.: Behaviour of CRO Staff and Compensation, Information Provided by
CRO Staff and Services by CRO. Significant positive relation was asserted by multiple
regression between ‘the factors considered, the awareness level and the objectives for
participation’ and ‘the overall participation experience’.

Conclusion: Majority of participants have low socioeconomic and education status.
Participants like repeated participation as around four-fifth of participants have
participated more than once. Government of India should allow to conduct such studies
is agreed by 95.2% respondents. Overall awareness level is average and top-rated
objective for participation is to get money but compensation is not one of top three
factors considered by participants for participation. Concerns for not to participate by
other people is not their less knowledge about safety precautions and trust in CRO
personnel but their family restriction and experience of participation in past. Participants
are not withdrawing the consent even they want to so because they feel they will lose
future medical care if required. Increase in awareness increases overall participation. This
study can provide a documented reference and add knowledge about participation
pattern in Gujarat state of India.
Key words: Early Phase; Bioequivalence; Pharmacokinetic endpoint; Questionnaire;
Validation; Face validity; Content validity.

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