CLINICAL RESEARCH / HEALTH ECONOMICS Managing GCP Issues Effectively in Your Clinical Project (0.5 day / intermediate virtual classroom) Do you need to know the rationale behind our clinical processes? Have you wondered why do companies seem to interpret ICH / GCP differently? Would you like to become more confident when dealing with GCP issues in your project? Have you perhaps found yourself discussing the requirements for source documentation or informed consent with a colleague, monitor or study coordinator and realised that your practices differ? Who is right? Could you both be right? Come prepared to see “GCP chestnuts” from a different perspective, join in some thought provoking discussion and walk away with some tangible tips. The workshop will use a number of case studies to illustrate the GCP issue management principles.
Planning and implementing a patient recruitment plan that works (0.5 day / intermediate virtual classroom) Recruitment issues can slow a study down and with the oft quoted “20% of sites recruit 80% of the patients”, what can you do when you find yourself in a slow recruiting site? Find out why patient recruitment is an active not a passive process and why it’s a process that begins when planning a study. This workshop will help you to look at different strategies for recruitment and planning for success. Tips for Effective Selection of Investigational Sites (0.5 day / intermediate virtual classroom) Ever wondered why a particular site was selected? Ever thought, if I had my time again, I would not select this site? A significant number of issues encountered once a clinical trial has started (including not meeting recruitment targets) can be traced back to deficiencies in site selection – site selection is much more than ticking the boxes on the company required checklist. This workshop asks you to put “first things first” and set up your trial and trial sites correctly. This workshop will be relevant to anyone new to selecting investigational sites and looking for some practical training on how to effectively plan for the visit, organise and prioritize your time while at the site and gain confidence with the types of questions you should be asking.
Be Prepared: A Practical Guide to GCP Audits (2 days / intermediate workshop) Would you like insight into a “day in the life” of an auditor? Are you looking for ideas to improve your monitoring and trial management? This course will raise awareness and provide a framework to appreciate the different stages of audit processes and activities of GCP audits. This is an interactive course suitable to the pharmaceutical/ devices industry and institution-based research staff such as study coordinators and investigators.
HEALTH ECONOMICS
TreeAge Training (2 days / introductory workshop) ARCS, in conjunction with THEMA Consulting and TreeAge Software, are happy to offer this 2 day TreeAge training course. The TreeAge course is designed to deliver a firm grounding in relevant concepts and practical experience in applying these concepts to common decision analysis problems. This training program leaves you with proven techniques, templates, example models and an 81 page training guide that you can refer to during and after the training. See also Health Economics for Non-Economists on Page 4. 8