Examples of trainings

Examples of Clinical trainings/workshops/seminars for beginners and those having little knowledge and experience in clinical research/monitoring (Basic level)

Introduction to Clinical Research

An interactive course focusing on in-depth discussion of the legal and ethical aspects of clinical research, terminology, etc. along with practical exercises and group briefings.

This course is a prerequisite for further trainings.

Target audience: Training/workshop for investigators, clinical trial coordinators, monitors and clinical research specialists
Duration: 4/6 hrs
Introduction to Clinical Research

An interactive course including overwies of the legal and ethical aspects of clinical research, terminology, etc. along with practical exercises and group briefings.

This course is a prerequisite for further trainings.

Target audience: Training/workshop for clinical trial assistants
Duration: 4 hrs
Good Clinical Practice Guidelines and Standards (ICH GCP)

An interactive course focusing on in-depth discussion of the main principles, standards and international requirements for clinical trials, and practical exercises on the key responsibilities of investigators and clinical monitors.

This course is a prerequisite for further trainings.

Target audience: Training/workshop for investigators, clinical trial coordinators, monitors and clinical research specialists
Duration: 4/8/16 hrs
Clinical Trial Monitoring

An interactive course focusing on in-depth discussion of the main principles, standards and international requirements for clinical trial monitoring, and practical exercises on the key responsibilities of clinical monitors conducting monitoring at the investigational sites.

Target audience: Training/workshop for monitors and clinical research specialists
Duration: 4/8/16 hrs
Quality of Clinical Research

An interactive course focusing on review and discussion of the main principles, standards and international requirements for clinical trials conduct, quality assurance, and quality control, and compliance with regulatory guidelines by all the involved parties.

Target audience: Training/workshop for investigators, clinical trial assistants, clinical trial coordinators, monitors and clinical research specialists
Duration: 4/6 hrs
Clinical Trial Protocol

An interactive course focusing on review of ICH GCP requirements to the contents of a trial protocol, trial design and on discussion of the key protocol sections, as well as practical exercises.

Target audience: Training/workshop for investigators, clinical trial coordinators, monitors and clinical research specialists
Duration: 2/4 hrs
Subject Informed Consent

An interactive course focusing on the review of practical aspects of the informed consent process, including the responsibilities of all the parties involved.

This course is a prerequisite for further trainings.

Target audience: Training/workshop for investigators, clinical trial coordinators, monitors and clinical research specialists.
Duration: 4/6 hrs
Source Documents and Source Documents Verification

An interactive course focusing on the review of the main principles, standards and international requirements for source documents at investigational sites with practical exercises covering the responsibilities of clinical monitors on the source documents verification and review process.

Target audience: Training/workshop for investigators, clinical trial coordinators, monitors and clinical research specialists.
Duration: 4/6 hrs
Investigational Product

An interactive course focusing on the review and discussion of the main principles, standards and international requirements for Investigational product handling, inventory, storage, use, return and documentation, as well as the responsibilities of all the parties involved.

Target audience: Training/workshop for investigators, clinical trial coordinators, monitors and clinical research specialists
Duration: 4/6 hrs
Safety of Clinical Trial Subjects

An interactive course focusing on the review of guidelines of ICH GCP and ICH E2A and the international requirements for clinical trial subjects safety, and the responsibilities of all the parties involved

This course is a prerequisite for further trainings.

Target audience: Training/workshop for investigators, clinical trial assistants, clinical trial coordinators, monitors and clinical research specialists
Duration: 4/6 hrs
Clinical trial Essential Documents

An interactive course focusing on the review of the main principles and international requirements for collection, handling and effective management of clinical trial essential documents, and the responsibilities of all the parties involved, including practical exercises

Target audience: Training/workshop for investigators, clinical trial coordinators, monitors and clinical research specialists.
Duration: 4/6 hrs
Monitoring Visit Reports

An interactive course focusing on the review of the main principles and requirements for monitoring reports and follow-up letters for investigators writing

This course is a prerequisite for further trainings.

Target audience: Training/workshop for monitors and clinical research specialists
Duration: 4/6 hrs

Examples of Clinical trainings/workshops/seminars for those having some knowledge and experience in clinical research/monitoring (Professional level)

Advanced Monitoring skills

An interactive course focusing on in-depth review of everyday tasks, challenges and difficult situations clinical monitor may face during investigational sites monitoring, and the discussion of typical monitoring issues and audit findings along with practical exercises, role play and group...

Target audience: Training/workshop for experienced, monitors and clinical research specialists
Duration: 8/12/16 hrs
Quality of Clinical research

An interactive course focusing on in-depth review and discussion of the main practical aspects of clinical trial monitoring, safety, quality assurance, quality control, and compliance with trial procedures, and international and local regulatory requirements by all the parties involved.

Target audience: Training/workshop for experienced monitors and clinical research specialists, investigators, clinical trial assistants, clinical trial coordinators
Duration: 4/8 hrs
Investigational product

An interactive course focusing on in-depth review of the main practical aspects of Investigational product management including handling, inventory, storage, use, return and documentation, the responsibilities of all the parties involved, and the discussion of typical issues and audit findings...

Target audience: Training/workshop for experienced monitors and clinical research specialists, investigators, clinical trial assistants, clinical trial coordinators
Duration: 8/12 hrs
Good Manufacturing Practice

An interactive course focusing on in-depth discussion of the main principles and international requirements for manufacturing and handling of Investigational product by all the parties involved.

Target audience: Training/workshop for experienced monitors and clinical research specialists, investigators, clinical trial assistants, clinical trial coordinators
Duration: 4 hrs
Clinical trial Essential Documents and managing Trial Files

An interactive course focusing on in-depth review, of the main principles and international requirements for collection, handling and effective management of clinical trial essential documents, and the responsibilities of all the parties involved, and the discussion of typical issues and audit...

Target audience: Training/workshop for experienced monitors and clinical research specialists, investigators, clinical trial assistants, clinical trial coordinators
Duration: 6/8 hrs
Subject Informed Consent

An interactive course focusing on the in-depth review of practical aspects of the informed consent process in compliance with the international principles, including the requirements the Informed consent form content and the responsibilities of all the parties involved, and the discussion of...

Target audience: Training/workshop for experienced monitors and clinical research specialists, investigators, clinical trial assistants, clinical trial coordinators
Duration: 6/8 hrs
Monitoring Visit Reports

An interactive course focusing on the review of the monitoring reports and follow-up letters for investigators contents, including the specific writing requirements for different monitoring visit types, and the discussion of typical issues and audit findings along with practical exercises.

Target audience: Training/workshop for experienced monitors and clinical research specialists
Duration: 6/8 hrs
Source Documents and Source Documents Verification

An interactive course focusing on the in-depth review of the main process of source documents maintenance at investigational sites including the discussion of all the parties involved, as well as typical issues and audit findings along with practical exercises covering the responsibilities of...

Target audience: Training/workshop for experienced monitors and clinical research specialists, investigators, clinical trial assistants, clinical trial coordinators
Duration: 6/8 hrs
Safety of Clinical Trial Subjects

An interactive course focusing on the in-depth review of guidelines of ICH GCP and ICH E2A and the international requirements for clinical trial subjects safety, safety reports and the responsibilities of all the parties involved along with practical exercises covering the discussion of the...

Target audience: Training/workshop for experienced monitors and clinical research specialists, investigators, clinical trial assistants, clinical trial coordinators
Duration: 6/8 hrs
Good Clinical Practice Guidelines and Standards (ICH GCP) - refresher

An interactive course focusing on in-depth discussion of the main principles, standards and international requirements for clinical trials, and practical exercises on the key responsibilities of investigators and clinical monitors.

Target audience: Refresher Training/workshop for experienced monitors and clinical research specialists, investigators, clinical trial assistants, clinical trial coordinators
Duration: 4/6 hrs
Accompanied site visit with clinical monitor and/or Line Manager to the investigational site

Various formats are applicable:

Target audience: On-job training for experienced monitors and clinical research specialists
Duration: 6/8/10 hrs

Examples of Clinical trainings/workshops/seminars for clinical research professionals (Advanced level)

Advanced Monitoring skills

An interactive course focusing on the acquisition of the variety of professional skills of clinical monitor required for selection, initiation, routine monitoring and closure of investigational sites including the discussion of the responsibilities of the parties involved along with practical...

Target audience: Refresher Training/workshop for experienced monitors, clinical research specialists, and clinical research professionals
Duration: 8/12/16 hrs
Good Clinical Practice Guidelines and Standards (ICH GCP) – refresher for professionals

An interactive course focusing on in-depth discussion of the main principles, standards and international requirements for clinical trials, and practical exercises on the key responsibilities of investigators and clinical monitors.

Target audience: Refresher Training/workshop for experienced monitors, clinical research specialists, and clinical research professionals
Duration: 4 hrs
Accompanied site visit with clinical monitor and/or Line Manager to the investigational site

Various formats are applicable:

Target audience: On-job training for experienced monitors and clinical research specialists
Duration: 6/8/10 hrs

Examples of Trainings/Workshops on Personal Development

Time Management Skills Training

An interactive course intended to review practical tools that help to effectively manage time

Target audience: Training/workshop for monitors and clinical research specialists, investigators, assistants and clinical trial coordinators
Duration: 8 hrs
Professional Communication Skills training

An interactive course focusing on the development of effective professional and interpersonal communication skills including practical exercises and role plays.

Target audience: Training/workshop for monitors and clinical research specialists, investigators, assistants and clinical trial coordinators
Duration: 8 hrs
Professional Presentation Skills training

An interactive course intended to develop skills on preparation, and delivery of presentations. The course helps to analyze and evaluate one’s own presentation skills and discuss colleagues’ presentations.

Target audience: Training/workshop for monitors and clinical research specialists, investigators, assistants and clinical trial coordinators
Duration: 16 hrs
Train the Trainer (on the request)

An interactive course focusing on teaching and coaching of potential trainers, on the development of their presentation and facilitation skills. The course includes practical exercises allowing trainers to analyze and evaluate their presentations in an efficient manner.

Target audience: Training/workshop for clinical trainers and clinical research specialists delivering trainings
Duration: 8 hrs
Delegation skills for managers

An interactive course focusing on the development of delegation skills when managing a project team

Target audience: Training/workshop for managers, clinical research managers, Line managers, project managers, and project leaders
Duration: 4/6 hrs
Leadership skills for managers

An interactive course focusing on the development of leadership skills when managing a project team.

Target audience: Training/workshop for managers, clinical research managers, Line managers, project managers, and project leaders
Duration: 4/6 hrs