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Abstract: Clinical trials and management is a unique course offered to the students of Biotechnology and life science graduates in few engineering institutions. This course recently came into limelight due to its huge value in the pharmaceutical job market in both India and abroad which also made private institutions to offer certification, diploma and special degree courses related to this field. This course needs a practice and activity based teachinglearning approach unlike other courses offered in the programme, due to its novel concepts and as to provide the learners complete knowledge to work in this clinical trial industry. To bring in the practicability approach various special assessment methods are applied which includes case study reports, sample clinical trial document preparation, open book test, seminar and also assessment by industry person. Apart from the unique assessment pattern followed, the activity based teaching-learning process such as mock clinical trials, guest lecture by industry persons, clinical trial documentary sessions, clinical trial scenario discussions, role play activities, etc were also emphasized. From the feedback collected from the 42 Biotechnology undergraduate students who learned the course under this method it was understood that they had a very different learning experience compared to the students who went through the conventional assessment system. As an outcome the impact of this course made many students from this group to get special interest towards this field and made a new trend in the student community, as many went to pursue higher studies and jobs related to this field. The students were able to understand the complete process behind clinical trials in an effective manner than in the conventional method. Thus, based on the learning outcome observed at the end of this course, it was evident that the use of such assessment methods brought in the practicability and effective learning of this course. The faculties and institutions offering similar courses could try such approaches specific for the courses to enhance their teaching- learning process.

Keywords

Assessment, Clinical Trials, Activity Based Learning, Practicability.
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