1.8 Introduction to the Regulation and Design of Clinical Trials

Course: 1.0 Medical Technology Regulation and Clinical Activities
Module: 1.8 Introduction to the Regulation and Design of Clinical Investigations for Medical Technology in Australia
Level:  1
Presenters: Dr Martin A. Devitt, Suzanne M. Williams and Stefan Czyniewski
Duration: Full day
Date:  Monday 6 September 2010
Time:  9:30 – 4:30 pm (morning tea, lunch and afternoon tea provided)
Location: Mobius Medical, Level 32, 1 Market Street, Sydney
Fee:  $950

Module information:
1.8 Introduction to the Regulation and Design of Clinical Investigations for Medical Technology in Australia has been scheduled following expressions of interest from industry. This module explores the practical issues surrounding the design, organisation, conduct, data management and reporting for medical technology clinical trials.

Medical technology industry employees working in clinical investigations should attend the training.  The recommended pre-requisite for this Level 1 module is to have downloaded from the internet and read Note for Guidance on Good Clinical Practice published by the TGA, 2000 prior to the training.

Learning outcomes
• Understands clinical investigation protocols.
• Identifies and assesses clinical investigation sites.
• Prepares and submits ethics committee submissions.
• Initiates and commences enrolment in clinical investigation sites.
• Monitors clinical investigations and reports adverse events.
• Understands how to manage data, clinical investigation close-out activities and write reports.

Program of learning
1. Welcome
2. Introduction and overview
3. Overview of medical device regulations.
4. Overview of clinical evidence.
5. Clinical investigations and use of unapproved medical devices in Australia and New Zealand (i.e., overview of the CTN/CTX schemes).
6. Standards used in medical device development (i.e., ICH GCP and ISO 14155, including terminology differences cf. pharma.).
7. History of clinical investigation regulation and GCP.
8. GCP by sections (i.e., major points of each of the eight (8) sections, as participants are expected to have pre-read GCP).
9. Clinical investigation development:
• Protocol and other essential documents
• Ethics submissions
• Regulatory submissions in the region
• Site selection
• Budgets
10. Clinical investigation monitoring:
• Pre-investigation
• Initiation
• Monitoring (consent, protocol deviations, safety reporting)
• Close-out.
11. Auditing (by whom, what, when).
12. Handling of unapproved medical devices:
• Device accountability.
• Shipping procedures.
13. Evaluation and close

Registration:
To register for this module, please click here.

Cancellation and refund policy:
Course fees will be refunded at 50% if cancellation notice is received after the specified closing date and before 48 hours of the course date. No refund will be provided within 48 hours of the course date.