Project Management for Clinical Research

FURTHER INFORMATION: 

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Clinical Research:  The Essentials of Monitoring

Root Cause Analysis and Corrective and Preventive Action (CAPA) Workshop

Preparing or a Regulatory Inspection

SIARA MODULES LIBRARY: 

Visit the Siara Modules Library for a collection of modules available for Sponsor Training.


This 2 day workshop has been developed for experienced Clinical Research Scientists who have a predominant role in monitoring. The primary focus of this course is to provide delegates with an array of challenging clinical research scenarios across a range of subject matter and to provide delegates with the opportunity to share / learn from their monitoring experiences. The intent of this training course is to allow delegates to draw on their knowledge of ICH GCP, external regulations/guidelines as well as their practical experiences to provide effective solutions to day-to-day issues in accordance with Good Clinical Practice.

The recent addendum to ICH E6(R1) - Guideline for GCP E6(R2) places a strong emphasis on quality management within clinical trials (ICH GCP 5.0) and the expectation now is for sponsors to perform root cause analysis and implement appropriate corrective and preventive actions (ICH GCP 5.20.1) to manage noncompliance.  Root Cause Analysis provides a process through which issues can be accurately identified and interventions can be effectively designed, implemented and monitored for effectiveness.


This 2-day workshop will provide delegates with the various tools used to conduct  root cause analysis and understand how to develop an effective CAPA process to ensure subject protections and data integrity is maintained in a clinical trial.  Writing a good CAPA is critical to this process and delegates will learn how to develop and document a good CAPA.  This workshop will focus specifically on the management of noncompliance issues occurring at investigative sites

The Inspector is coming!  The key to effective management of regulatory inspections is preparation. This practical and interactive 2 day workshop will provide and insight into what regulatory inspectors look for during an inspection and how to prepare for a regulatory inspection.  This workshop will help delegates determine how to build a robust system for handling regulatory inspections and ensuring that all employees follow the process.  Recent key inspection findings will be presented and measures to proactively prevent them from occurring at sites will be discussed in detail.  This workshop will focus on investigative site inspections.  In addition the US FDA Inspection process will also be addressed.

Advanced Monitoring


With the urgency to deliver on good clinical trials faster and with quality, the need for strong project management skills is greater than ever. This 2 day workshop is specifically designed for clinical research professionals.  This workshop will provide the project management skills required to successfully manage clinical trials.  Through interactive exercises and scenarios, delegates will learn how to manage and direct clinical their clinical trials rather than simply tracking their progress.  This workshop will provide practical guidance on the project management skills employed by clinical research professionals.

​This 4 day workshop has been developed specifically for Clinical Research Scientists that are fairly naïve to clinical research.  The workshop will provide a platform from which delegates will gain an understanding and appreciation of the clinical research process and in particular the role and responsibilities of the monitor.  With a strong focus on the ICH GCP requirements for monitoring, the primary objective of this course is to equip the delegates with the tools and knowledge to able to confidently select, initiate, monitor and close investigative sites in accordance with ICH GCP requirements.


CLINICAL RESEARCH TRAINING & CONSULTANCY

SPONSOR TRAINING


Siara offers an array of workshops for different levels and types of experience in clinical research, as well as different versions of the coursework to fit the needs of your business.


Whether a multi-day workshop or a one day intensive course is required, rest assured a tailored solution to your specific needs with relevance to the opportunity or issue at hand will be delivered.


Siara has a vast library of modules that can be delivered on a ‘stand-alone’ basis or a tailored course can be developed comprising of a collection of modules as per the requirements of Sponsor clients.  


Below are a few examples of the Sponsor Solutions offered by Siara.