AOPEER Principles of Clinical Research & Study Management and Good Clinical Practice (GCP) package

date

December 7-9, 2019

 

Chairpersons

 

Matthew J. Allen, MA VetMB PhD MRCVS

Professor of Small Animal Surgery, University of Cambridge, UK

Frankie Leung, MD

Chief of Division of Orthopaedic Trauma, Queen Mary Hospital Hong Kong

Risto Kontio, MD, DDS, PhD

Vice Chair and Specialist Maxillofacial Surgeon, University of Helsinki, Finland

COURSE Goal

Principles of Clinical Research

The goal of this course is to introduce the principles of clinical research, including skills and knowledge on why and how to do research, how to build a good research environment, and where to find additional resources, tools, and reference packages to support a research project.

Study Management and GCP

The aim of this course is to contribute to the quality of conducting clinical studies at an investigational site by training the investigators about the applicable guidelines and providing practical tips on how to conduct a study including examples and project management tools.

Target participants

Principles of Clinical Research

This course is targeted at individuals who want to learn or improve the skills for conducting clinical research and publishing results and also at those with a general interest in research and documentation of clinical cases.

Study Management and GCP

This course is targeted toward certified orthopedic and trauma surgeons, residents, and other medical doctors acting as investigators and/or subinvestigators. This course is also open for study coordinators and any other specialists involved or interested in clinical research.

Learning objectives  

Principles of Clinical Research

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

  • Explain the importance of doing research and the link to evidence-based medicine.
  • Apply the basic principles of literature search and critical appraisal.
  • Follow GCP guidelines and adhere to ethical requirements, eg, informed consent.
  • Identify a clinical problem, formulate a clinical research question, and select the study design.
  • Collaborate with a statistician to perform sample size calculation and basic statistical analyses.
  • Describe the principles of medical writing.
  • Utilize available research environment, resources, and tools.

 

Study Management and GCP

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

Recognize the importance of conducting research involving human participants.

  • Explain the importance of protecting human participants in the design, conduct and follow- up of research projects involving human beings.
  • Describe the principles of human research participant protection.
  • Identify and describe the basic documents of reference in research ethics
  • Explain how conflicts of interest, fraud, and science misconduct can impact design, conduct, and follow up and the measueres to counter them.
  • Apply the basic rules of research ethics to assess risks,-

       - Obtain informed consent, respecting the participant privacy, obtain ethical clearance

       - Obtaining ethical clearance from the competent Research Ethics Committee (REC)

  • Describe the responsibilities of investigators in the protection of human participants and how they have the capacity to face them.
  • Apply the most relevant project management tools in a clinical study.

Course description

Principles of Clinical Research

Participants will learn about the importance of research and evidence-based medicine (EBM), the relevant ethical considerations and guidelines for Good Clinical Practice (GCP) with a focus on the formulation of a clinical research question.


In addition to practicing some of the skills related to critical literature review, this course offers support in working with a statistician, and navigating the AO Program for Education and Excellence in Research (AOPEER) to help make their research project a success.

Study Management and GCP

This 2-day course is organized in eight modules and includes lectures, interactive workshops as well as panel and group discussions, preceded by online preparation activities.


The course explains the importance of Good Clinical Practice (GCP) guidelines and the ISO 14155 standard for the conduct of clinical studies as well as presenting the basic ethical principles according to the Declaration of Helsinki.


For more information, please visit www.aopeer.org. Access is free for all members of an AO Clinical Division.

Course Program

Please find the first preliminary course programs at the bottom of this page.

Pricing, Payment options and information

Pricing:

CHF 600.00

20% for AO members, AO Alliance and AO employees
10% for any non-for-profit organization and SwAPP members 
Credit card payments are preferred

Cancellation will be charged as follows:
50% until 30 days before the event. No refund thereafter.
Participants should make sure they have cancellation insurance.

Invoice:
If you cannot pay via credit card you can request an invoice. Please note that we will charge you a  CHF 30 handling fee in addition to the participant fee. Please therefore contact aopeer@aofoundation.org and indicate the official invoice address of the paying person or entity as well as a respective email address the invoice has to be sent to.

Registration

Please register here.

Included

  • Course material
  • Coffee breaks
  • Lunch
  • Business center at course venue

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