CLINICAL RESEARCH TRAINING & CONSULTANCY

The Inspector is coming! The key to effective management of regulatory inspections is preparation. This 1 day workshop will give an insight into what regulatory inspectors look for during an inspection and how the investigator should prepare for a regulatory inspection. This 1 Day 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. 

Preparing for a Regulatory Inspection

Protection of Human Subjects:  Informed Consent and the Subject

Creating a Clinical Trial Budget

It is recommended that this 2-Day workshop be attended by all key site staff (Investigators, Sub-Investigators and Study Coordinators).  This workshop will provide an advanced, in-depth understanding of the structural elements of Good Clinical Practice (GCP).  Through problem-centric exercises and scenarios, delegates will understand the practical application of GCP guidelines and local regulations for critical components of the clinical research process.  Delegates will be able to apply knowledge acquired from discussion of current quality issues to improve future clinical trial conduct. 

FURTHER INFORMATION: 

Please contact one of our Consultants for more information on Sponsor Training solutions on:

+44 (0) 203 609 8604 or email:  admin@siarapte.com

It is recommended that this 2-Day workshop be attended by all key site staff (Investigators, Sub-Investigators and Study Coordinators).  This workshop will provide an advanced, in-depth understanding of the structural elements of Good Clinical Practice (GCP).  Through problem-centric exercises and scenarios, delegates will understand the practical application of GCP guidelines and local regulations for critical components of the clinical research process.  Delegates will be able to apply knowledge acquired from discussion of current quality issues to improve future clinical trial conduct. 

Protection of human rights is one of the fundamental principals of GCP. This 1 Day workshop will discuss the history of informed consent, the development of the informed consent form and the informed consent process. The key issues in informed consent will be discussed and the roles of the Legally Acceptable Representative and Impartial Witness will be addressed. The dilemmas and issues in consenting vulnerable subjects will be discussed in detail. Current inspection findings will be presented. This is a very practical workshop incorporating role-play, problem scenarios and videos. The documentation expected to demonstrate compliance to the informed consent process will also be described in detail. 

This 1 day workshop provides the practical skills needed to construct and negotiate study budgets that appropriately compensate investigative sites for resource needs required as a result of clinical research protocols. Delegates will be taken through a detailed five-step process on how to create a clinical study budget. Factors impacting study budget will be discussed as well as budget templates will be provided with tips and tactics on budget negotiation also being discussed. A study budget will be created during the workshop. 

Advanced GCP: Improving Efficiency and Quality in Clinical Trials

SIARA MODULES LIBRARY: 

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

This 2 Day workshop would set the foundations on understanding the requirements of ICH GCP and on how to successfully conduct a clinical trial, ensuring the safety, rights, well being of the trial subjects are protected and the data that is produced from the clinical trial is complete accurate and unbiased.  


This workshop is applicable to all Investigators, Sub Investigators, Study Coordinators and other relevant site staff.


NOTE:  This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

Clinical Research:  The Principles of Good Clinical Practice  

INVESTIGATOR TRAINING


Siara understands the need for highly trained and skilled clinical Investigators partnering pharmaceutical and biotechnology companies.  Training ensures that investigators and their site staff understand and can apply provisions to protect the rights, safety, and well-being of study participants.

With this in mind Siara has developed Investigator training to nurture Investigators and sites into ‘centres of excellence’ for clinical research.  Below is a selection of workshops available for Investigators and Site Staff​.