Clinical Research

Course description

The course objective is to provide attendees with an introductory level overview of clinical research and new drug development process, including players, timelines, common terminology, regulations, guidelines, safety reporting and patient protection.

Key Topics

• Clinical Research, a Historical Review
• New Drug Development
• Taking a Drug/Protein from the Laboratory to the First Tests in Humans
• Getting a Product to the Market – The clinical development phase
• The Player and the Process (Workshop)
• Common Terminology used in Clinical Research
• Clinical Trial Design
• Protecting Clinical Trial Subjects
• Fraud and Misconduct
• Quality Management
• Reporting Safety issues
• Supporting literature

Learning Outcomes

At the end of this course the participant will

• Understand the historical, ethical, societal and commercial background of clinical research
• Evaluate the ethical principles relevant to clinical research
• Be familiar with the major steps in the preclinical and clinical development of drug /medical device research
• Understand the phases of clinical trial for human subjects
• Acknowledge the major players in the process of clinical research
• Have knowledge about the various distinctions and elements of trial designs
• Have knowledge how to best protect clinical trial human subjects
• Know how to best avoid fraud and misconduct in clinical trials
• Understand the major elements of quality management in clinical trials
• Understand the importance and process of safety reporting

Course description:

Protection and safety of study participants is of utmost importance in all clinical research projects. Review of all clinical research projects by independent ethics committees is therefore required. In this course the participants will explore the ethical aspects of clinical research, study participant protection and the work and processes of ethics committees. Research in vulnerable populations, such as children and incapacitated adults as well as cross cultural considerations will also be covered. This course is suitable for ethics committees’ members, researchers and all other staff involved in clinical research.

Key Topics:

• Ethics in Research and its importance
• Applicable Regulations, Declarations & Guidelines
• Cross-cultural Considerations in International Collaborative Research
• Vulnerable Populations
• Informed Consent
• Fraud and Misconduct
• Ethics Committee

Course Faculty:

Our course faculty includes members from Ethics Committees, academics and other highly specialized professionals in Clinical Research and regulations.

Faculty members are contracted by the VSCR and committed to provide independent teaching of state-of the-art principles.

Learning outcomes:

At the end of the course the participants will (be)

• able to develop and understand the principles and basic considerations of ethics in clinical research
• appreciate the roles and the responsibilities of ethics committees as defined by current regulations
• learn about ethical clinical research in vulnerable patient populations
• understand the legal, administrative and organizational aspects associated with ethics in clinical research
• understand ethical aspects in global clinical research

Course description

The ICH Guideline for Good Clinical Practice (GCP) is an internationally recognized ethical and scientific standard for the conduct of clinical trials. Research physicians and other trial staff must be familiar with this guideline. Since many years VSCR has been providing 2 days courses on GCP.

Key Topics

• ICH GCP Terminology and Commonly used Abbreviations
• The History of GCP and the ICH GCP Principles
• Investigator Responsibilities
• Essential Documentation
• Sponsor Responsibilities
• Ethics Committee Responsibilities

Learning outcomes

At the end of the course the participants will be able to

• Understand the implications and background of Good clinical practices.
• Know and understand the importance of various laws, guidelines, frameworks etc. on which the conduct of clinical research is based
• Realize the roles and responsibilities of different individuals and organizations in clinical research
• Know and understand different regulations and various procedures involved with these regulations
• Have a thorough understanding of essential documents and the trial master file
• Know that this knowledge is dynamic and keeps changing and therefore needs refreshing and updating at regular intervals

Course description

This course has been designed to provide intensive, highly practice oriented training of Good Clinical Practice for advanced clinical researchers. Presentations will be accompanied by workshops allowing participants to apply their knowledge within practical exercises and animated discussions.

Key topics

• Providing opportunities to share knowledge and experience with trainers and colleagues
• Deepen knowledge and understanding of Good Clinical Practice
• Consider potential solutions for the most frequent issues and pitfalls in clinical research
• Develop an understanding of the role of ethics committees in clinical research
• Update knowledge of regulatory and ICH-GCP guidelines

Learning Outcomes

At the end of the course, the participants will be able to:

• have a short refresher and revise the main topics of GCP
• translate the understanding of GCP into practical day to day work in Clinical Research
• know and identify the challenges faced in adhering to GCP
• deal with these challenges and find a way forward to work with the guidelines.
• Deal with GCP challenges in terms of informed consent process, vulnerable subjects etc.
• Understand on how to improve safety reporting and detect fraud and misconduct
• have a good understanding of electronic source data and CRFs
• trained on audit and inspection readiness

Course description

Controlling the quality in clinical trials is essential. Monitoring of clinical trial data and investigational sites is therefore a prerequisite for all clinical trials and is also outlined in international guidelines for clinical research (ICH). This course has been designed to prepare personnel new to the role and responsibilities of a Clinical Research Associate/Monitor. The course incorporates soft skills essential for this role, such as time management and communication skills together with the technical skills needed to successfully manage a clinical trial site.

Key Topics

Role, Responsibilities and Characteristics of Good CRAs

• Site Feasibility and Selection
• Site Preparation and Initiation
• Site Preparation and Initiation
• Essential Documents
• Source Document Verification
• Data Management
• Quality Assurance and Control
• Preparation & Planning – The Key to Successful Monitoring

Learning outcomes

At the end of the course the participants will be

• able to understand and execute the role of a clinical research associate/monitor in an efficient manner
• capable of understanding the roles and responsibilities of the different players in clinical trial especially at the site and be trained on task management with each player.
• able to well comprehend the monitoring responsibilities and act on them
• enabled with an in-depth understanding of the Site selection process
• have been trained to have a thorough Site preparation, Site initiation and Site closure
• acquainted with the monitoring responsibilities
• have a thorough insight into Essential documents, Data management and Study drug management.
• Familiarized with the safety reporting procedures and regulations.
• trained to identifying and manage compliance and noncompliance; including audits and inspections
• trained in soft skills like optimizing communication, time management and prioritization.

Course description

To ensure the safety of subjects participating in clinical trials and to ensure that credible data are generated the inclusion of laboratory tests within clinical research is essential. Whilst there are internationally accepted guidelines that address Good Clinical and Good Laboratory Practice, there is a need for guidance that ensures practical implementation of the guidelines within laboratories working with samples collected for clinical research purposes.  Good Clinical Laboratory Practice bridges the gap and training on these guidelines is essential for all laboratory staff working with clinical research samples.

Key Topics

All laboratories participating in clinical research are subject to rigorous evaluation, at a minimum they must prove their ability to confirm to the standards demanded by GCLP.

Who Should Attend this Course?

Individuals directly involved or having interfaces with laboratory procedures:

• Laboratory management personnel
• Laboratory technicians
• Quality assurance personnel
• CRAs/Monitors

Learning Outcomes

To gain the most from this course, applicants will have an understanding of ICH GCP and common technical terms used within clinical research and ideally will have practical laboratory experience.

Participants will leave this course being able to:

• Comprehend the principles of GLP and GCLP guidelines
• Understand the importance of producing consistent, reproducible, auditable, and reliable laboratory results.
• Understand the procedures to be followed in a laboratory in compliance with GCLP
• Understand what an Analytical Plan consists of
• Understand when and why SOPs are needed
• Prepare for audits and inspections
• Identify and handle essential documents in the laboratory

Course description

This course is designed for:

• Governmental institutions
• Ministries of Health
• Health Policy makers
• Clinical research investigatots
• Clinical study coordinators
• CRAs und monitors

Topics:

• General principles on safety monitoring, reporting and evaluation
• Safety regulations in US
• Safety regulations in EU
• Post-marketing Safety Studies and Surveillance
• The Benefit Risk Assessment
• Specific country requirements

Learning Outcomes

At the end of this short course the course participant will be able to know

• the historical context of Pharmacovigilance and its need
• the legal tools for PharmacoVigilance
• marketing authorisation procedures in the European Union
• the role of European Medicines Agency
• the major principles and elements for good pharmacoVigilance Practices (GPP)
  • - Qualified Person responsible for PharmacoVigilance,
  • - Pharmacovigilance System Master File,
  • - Inspections Risk Management Plans,
  • - Spontaneous reporting,
  • - Post-Authorisation Safety Studies and
  • - Periodic Safety Update Reports (PSUR)

Course description

This course provides the opportunity for reinforcement of basic principles and concepts of biostatistics through hands-on exercises, followed by highly advanced material. The objective of the program is to give participants an advanced understanding of basic skills and a good understanding of some more complex statistical methods.

Key topics

• Types of data
• Types of data distributions
• Data Analysis Methods
• Risk and rates
• Hypothesis testing and confidence intervals
• Significance tests
• Correlation and regression
• Hands-on Exercises
• guidance and regulatory documents ICH, FDA, CHMP, CONSORT, QUORUM, STROBE

Learning outcomes

At the end of the course, the participants will be able to:

• Store, manipulate and analyse data using the SPSS statistics package
• Carry out general purpose statistical procedures such as analysis of variance and correlation and regression methods
• Recognise the advantages of adjusted analyses such as analysis of covariance and perform appropriate testing
• Recognise when time-to-event data includes censoring and be able to apply survival analysis techniques to such data
• Analyse data where the outcome is recorded as a categorized end-point, using logistic regression
• Combine published data from more than one study, using meta-analysis
• Identify different types of study design and describe their strengths and weaknesses
• Be aware of the dangers of multiple statistical testing and conduct analyses that circumvent these problems
• Recognise the problem of non-compliant subjects and describe the strengths and weaknesses of per-protocol and intention-to-treat analyses
• Be aware of the policy statements from various international bodies concerning data analysis

Course description

This course provides the opportunity for reinforcement of basic principles and concepts of biostatistics through hands-on exercises, followed by highly advanced material. The objective of the program is to give participants an advanced understanding of basic skills and a good understanding of some more complex statistical methods.

Key topics:

• Types of data
• Types of data distributions
• Data Analysis Methods
• Risk and rates
• Hypothesis testing and confidence intervals
• Significance tests
• Correlation and regression
• Hands-on Excercises
• guidance and regulatory documents ICH, FDA, CHMP, CONSORT, QUORUM, STROBE

Course Faculty

We are proud to introduce our very esteemed team of statisticians and clinical researchers

The participants will benefit by their vast experience and knowledge in the field of statistics.

Faculty members are contracted by the VSCR and committed to provide independent teaching of state-of the-art principles.

Learning outcomes

At the end of the course, the participants will be able to:

• Store, manipulate and analyse data using the SPSS statistics package
• Carry out general purpose statistical procedures such as analysis of variance and correlation and regression methods
• Recognise the advantages of adjusted analyses such as analysis of covariance and perform appropriate testing
• Recognise when time-to-event data includes censoring and be able to apply survival analysis techniques to such data
• Analyse data where the outcome is recorded as a categorized end-point, using logistic regression
• Combine published data from more than one study, using meta-analysis
• Identify different types of study design and describe their strengths and weaknesses
• Be aware of the dangers of multiple statistical testing and conduct analyses that circumvent these problems
• Recognise the problem of non-compliant subjects and describe the strengths and weaknesses of per-protocol and intention-to-treat analyses
• Be aware of the policy statements from various international bodies concerning data analysis

Course description

This VSCR course offers a unique opportunity to experienced clinical researchers interested in designing clinical trials. At the end of the training participants will have the basic knowledge in designing clinical trials and developing protocols including the essential statistical principles. Lectures are supplemented by workshops, discussions and individual working sessions.

Key topics:

• current state-of-the-art of treatment and research in the therapeutic area
• current scientific evidence
• interpreting clinical trial data
• protocol writing and protocol development
• design and conduct of clinical trials in psychiatry
• statistical reasoning in clinical trials
• clinical outcome measures and endpoints

The Faculty

 The course faculty is drawn from international experts including university professors, clinical researchers and industry representatives; in addition the course is supported by an experienced statistical advisor. Faculty members are contracted by the VSCR and are committed to provide independent teaching of state-of-the-art principles.

Application Criteria

 The following pre-requisites should be met by applicants:

• clinical experience in the relevant therapeutic area
• have an interest in designing, conducting and leading clinical trials
• fluency in the English language

 Course description

This course is designed for representatives of

 Governmental institutions

• Ministries of Health
• Health Policy makers
• Clinical research investigatots
• Clinical study coordinators

Topics:

• Surveillance of GCP activities: GCP versus GMP and GLP - what are the differences in inspection?
• Inspection approach: Risk based setting
• Training of inspectors for GCP inspections
• Checklist based inspections versus system based
• Procedure of inspection announcement, performance and report writing
• The inspection preparation, what time to calculate, what issues are important, interfaces to other units
• The inspection setup: Start Up meeting, document review, source data review
• Follow up of inspections, inspection report structure, re-inspection
• Database of running clinical trials, clinical trial assessment and acceptance
• International training opportunities
• Interfaces to industry and clinical trial sites: Communication
• Time needed for calculation: From preparation to follow up, Key Performance Indicators for the Head of the Inspectorate
• Inspection fees

Learning outcomes

At the end of this short course the course participant will be able to know

• About risk assessment of clinical trials
• Assessing the different parts of clinical trial applications: Essential documents
• How to assess GCP compliant protocols
• Ressource calculation: Personnel, database
• the major principles and elements for assessment
  • - Sponsor Quality Management
  • - Application forms
  • - EC interaction
  • - financial agreements
  • - Informed Consent forms

Course description

This course is designed for representatives of

 Governmental institutions

• Ministries of Health/regulators
• Health Policy makers
• Clinical research investigators
• Clinical study coordinators
• Auditing institutions
• Industry governance staff

Topics:

• Surveillance of GCP activities: GCP versus GMP and GLP - what are the differences in inspection?
• Inspection approach: Risk based setting
• Training of inspectors for GCP inspections
• Checklist based inspections versus system based
• Procedure of inspection announcement, performance and report writing
• The inspection preparation, what time to calculate, what issues are important, interfaces to other units
• The inspection setup: Start Up meeting, document review, source data review
• Follow up of inspections, inspection report structure, re-inspection
• Database of running clinical trials, clinical trial assessment and acceptance
• International training opportunities
• Interfaces to industry and clinical trial sites: Communication
• Time needed for calculation: From preparation to follow up, Key Performance Indicators for the Head of the Inspectorate

Learning Outcomes

At the end of this short course the course participant will be able to know

• the difference in approach for inspections versus audits
• the global harmonization approach
• How to establish an inspection policy for HA
• Ressource calculation: Personnel, database
• the major principles and elements for inspection planning
  • - Quality Management System, SOPs
  • - report writing
  • - harmonization of grading of inspection findings
  • - Pharmacovigilance in Clinical Trials: SAE, DSUR, PSUR
  • - Inspection planning: Preparation, Performance and Follow Up
  • - Urgent safety measures by inspectorates
  • - Sponsor, site and CRO inspections
  • - Financing

Course description

This course provides intensive, praxis-oriented training for clinical research professionals responsible for clinical trial project management.

Key Topics

• Introduction to Project Management
• Starting a Project
• Planning a Project - Initial Steps
• Creating a Responsibility Matrix and Estimating
• Creating a Project Task Network and Schedule
• Resource Forecasting
• Creating a Project Budget
• Risk Management
• Project Communication
• Project Team Management
• Implementation, Tracking and Control
• Project Close Out

Learning Objectives

• define basic project management terms
• create a work breakdown structure and task network
• develop a skills matrix
• define a project schedule and conduct critical path analysis
• analyze resource requirements
• describe and apply a process for managing risks
• list the common parameters that need managing and tracking
• outline a general process for dealing with variance
• outline techniques for modifying the project plan
• develop strategies for managing change
• define strategies for managing and maintaining an effective project team

Course description

This training provides intensive, practical training for clinical research professionals involved in publishing a broad variety of formats. Building on the publication of randomized clinical trials, this advanced Masterclass focuses on different publication types and explores relevant topics including how to publish abstracts, posters, review articles, observational studies and case studies. Practical tips and tricks as well as major pitfalls are discussed in practical case studies and workshops.

Key Topics

• Types of Publications
• Epidemiological Studies
• STROBE Guidelines
• Writing Posters for Meetings
• Guidelines for Publications
• Referencing, Literature Searching and Search Strategies
• Review Articles, Meta-analyses and Systematic Reviews
• Working with co-authors

Faculty

The course faculty is drawn from a pool of leading international experts including university professors, clinical researchers, ethics committee members, industry representatives and representatives from other relevant areas. Faculty members are contracted by the VSCR and committed to provide independent teaching of state-of the art principles. Faculty members are contracted by the VSCR and committed to provide independent teaching of state-of the-art principles.

Key Learning outcomes

At the end of the course the participants will be able to:

• Understand the different types of writing and different styles used in writing
• Know the correct usage of words, sentences and paragraphs
• Understand the formal elements of a research paper
• Understand and be able to write a good introduction. Know the function of an introduction and how to best use it in your context
• Understand function of Materials & Methods for the study overall and be able to identify principles of organization for hypothesis-testing papers, method papers and descriptive papers
• Understand how to structure Results in hypothesis-testing papers, method papers and descriptive papers; become aware of its close relation to Materials & Methods
• Identify the components of the Discussions
• Learn how to indicate your study’s merits and indications
• Identify the right references and to be able to use the correct styles
• Understand the importance of a summary and be able to have an effective summary sending out the right information in the right proportions
• Deal with Journals effectively and efficiently
• Avoid and deal with writing obstacles
• Understand observational and epidemiological studies
• Familiarize with reviewing articles and meta-analyses
• Able to write abstracts and posters for meetings
• Well acquainted with tables and figures
• Understand the research ethics
• Know and demonstrate different writing styles
• Know and understand the art of referencing
• Understand and know the skills to work with co-authors
• Perform a publication planning
• Conduct reviewing of publications