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JSS College of Pharmacy, Mysore

Series of Guest Lectures on Clinical Trial Start-Up Activities

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Department of Pharmacy Practice organised a series of guest lectures on the topic ‘Clinical Trial Start-Up Activities’ for the Pharm.D, Postgraduate Diploma in Clinical Research and Postgraduate Students of Pharmacy Practice from 17th – 19th January 2023. Dr. Rovin Mathew Theempalangad, Clinical Research Associate, Clinical Development Services Agency (CDSA), Center for Clinical Research Excellence (CCRE), JSS Hospital, Mysuru was the resource person. The lectures were held in three sessions as given below. Session 1: 17/01/2023 – 5.00 PM - 6.30 PM Session 2: 18/01/2023 – 5:00 PM – 6:30 PM Session 3: 19/01/2023 – 5:00 PM – 6:30 PM In the first session, Dr. Rovin explained the importance of site feasibility questionnaire and the different elements included in it. Also, he explained about the Site/ Investigator Selection, Vendor selection process in a clinical trial. Dr. Rovin T Mathew during Session on Site Feasibility Second session was more focused on ‘Essential Documents’, that needs to be maintained prior, during and post clinical trial with different clinical trial stakeholders. Importance of pre-study visit by the sponsor to the site and also the need of investigators meeting was discussed in second session. In the third session, he focused on preparation of informed consent and its translation to different languages. Also, he explained on clinical trial agreement execution and the procedures involved in ethics committee document preparation and submission during this session. Session 2 – Site Essential Documents In the third session of the lecture series, Dr. Rovin explained about procurement and storage of investigational product, filing procedures and about the site initiation visit. Also, he discussed on different files, that need to be maintained at the site throughout the study such as Trial Master File, Investigator Site File/Regulatory Binder and Pharmacy File Dr. Rovin T Mathew during Session 3 on Investigational Product All the three sessions were attended by Postgraduate Diploma in Clinical Research, Postgraduate Pharmacy Practice and Pharm.D students. Dr. Rovin shared his experiences of site start-up activities during each of the sessions. Also, he highlighted the practical difficulties faced by a site in completing the activities before the start of the study. Students got an opportunity to interact with the speaker and clarify all their doubts. Students expressed that all the three sessions were very useful.

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