FURTHER INFORMATION: 

Please contact one of our Consultants for more information on the specific content and objectives of the training modules on:

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

The above list is not exhaustive.  Specific modules based upon client request and requirements can be developed.

INVESTIGATOR TRAINING  MODULES

SPONSOR TRAINING MODULES

CLINICAL RESEARCH TRAINING & CONSULTANCY

Understanding Clinical Trial Design
Working with IECs/IRBs
Investigator Selection
Informed Consent and the Subject
Informed Consent - development and Implementation 
Safety in Clinical Trials
Drug Accountability
Clinical Study Monitoring
Monitoring Visit Report Writing
Essential Documents & Source Documentation 

Developing Recruitment Strategies

Risk Based Monitoring
Investigator Obligations
Sponsor Obligations
Investigator Study File Management
Sponsor Study File Management
Conducting Studies under the US IND
Preparing for an Audit
Preparing for a Regulatory Inspection

Good Clinical Practice:  An Overview

Overview of Drug Development
Clinical Research Methodology - The Basics
Being an Investigator:  Investigator Obligations

Planning for a Clinical Trial

Players in Clinical Research

​Role of Sponsor in Clinical Study Management

Creating a Clinical Study Budget

Taking the Lead in Recruitment

Documentation  in Clinical Trials
Informed Consent and the Subject

Informed Consent - development and Implementation 

Conducting Studies under the US IND
Safety in Clinical Trials
Drug Accountability
Essential Documents & Source Documentation 
Investigator Study File Management
Preparing for an Audit
Preparing for a Regulatory Inspection

Quality in Clinical Research

MODULE LIBRARY


The following modules have been developed Siara for Sponsors and Investigators.  The modules can be delivered on a ‘stand-alone’ basis or a tailored course can be developed comprising of a collection of modules as per client requirements.  Module duration ranges from 0.5 - 1 day.  Each module can be customised for the role, responsibility and experience of the audience.,


Please contact a Siara Consultant for further intimate details on the modules