Workshop on conducting an Academic Clinical Trial in a hospital setting
2023 April 26 (Wed) and 27 (Thu) 2:00 PM to 4:30 PM

What is an Academic Clinical Trial?
Definition: “Academic clinical trial” means a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic or research institution for a new indication or new route of administration or new dose or new dosage form, where the results of such a trial are intended to be used only for academic or research purposes and not for seeking approval of the Central Licensing Authority or regulatory authority of any country for marketing or commercial purpose.

Workshop Highlights:
- Provides clarity on fundamental concepts of Randomized Controlled Trial
- Introduces different trial designs used in Academic trials
- Hands on experience in generation of randomization sequence
- Group activity and role plays to demonstrate allocation concealment and blinding
- Details on how to manufacture placebo tablets
- Basic statistical analysis, data management and presentation of trial data
- Guidance on how to successfully apply for regulatory approvals
- Experience sharing by clinicians, challenges faced
- Critical appraisal of journal articles (RCT)

Who should attend?
Faculty, Residents, Students and Researchers.

Benefits
This workshop will prepare the participants to confidently undertake a clinical trial in an academic setting, which includes investigator-initiated trial, student thesis etc.

Certificate will be provided.

Workshop details
Date: 26 (Wed) and 27 (Thu), April 2023 (2 half days post lunch)
Time: 2:00 PM to 4:30 PM
Venue: Admin Block (Ground floor), St. John’s Research Institute

Registration Details:
Number of participants: 20 only (First come, first serve basis)
Registration fees: Rs.500/-, including GST (Five hundred only)

Registration process
1. Check the Google form to confirm that registration is open.
2. Pay the registration fees of Rs. 500/-.
3. Fill and submit the Google form.

Account Details for payment:
Beneficiary name: St. John’s Research Institute
Bank name: Bank of Baroda Branch: John Nagar
St. John’s Medical College, Bangalore-560034
A/c no: 05210100024920
IFSC code: BARB0STJOHN (5th digit Zero)

Google form:
https://docs.google.com/forms/d/e/1FAIpQLSeFkBNHvycp3MBCvDDCWLHzzv113yjSr3UDTBBxOe zJ3TAo4g/viewform

Contact:
Office: o8o-4946-7036/6123
Mobile: +91 9538147676
Email: biostatws@stjohns.in
Website: www.stjohns.in / www.sjri.res.in
Please note that the form maybe closed after enrolling 20 participants with confirmed payment. You can send an email for further queries.

Workshop Director
Dr. Tinku Thomas
HOD & Professor
Dept of Biostatistics
St John’s Medical College, Bengaluru

Workshop Coordinator
Dr. Arjun M. C., MD
Research Fellow
St John’s Research Institute
St John’s Medical College, Bengaluru

Attachment: Workshop on conducting an Academic Clinical Trial in a hospital setting