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The nuts and bolts of putting a research study into operation: a workshop for Study Coordinators and Investigators

November 16, 2015

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Who is this course aimed at?

Study coordinators, researchers, investigators, project managers or any person in the research team who have a clinical study or trial to implement and who need help in the practical steps to get it done.

This intensive 2 and half day course covers important aspects of implementing a study as well as  quality management.

What will be covered?

  • The life cycle of a research project
  • External and Internal Role Players in clinical research
  • Preparing submissions for ethics and other approvals
  • Putting together a research team
  • Developing systems and SOPs
  • Designing your tools for optimal quality and efficiency : the informed consent, source documents, CRFs and other documents
  • Good Documentation Practice and ALCOA
  • Recruitment and Retention Plans
  • The philosophy,regulatory framework and application of quality management in clinical research
  • The difference between quality control, quality assurance and quality management
  • Developing, writing and implementing a clinical quality management plan (CQMP)
  • Understanding and writing Corrective action, Preventative action (CAPA) plans/reports
  • Operational metrics: what to measure and how
  • Keeping your data clean and manageable and your research ethical and sound

To get the most out of this course, we highly recommend that participants have attended a prior GCP course.

What is the focus of the course?

The focus is on applying GCP principles in the field, on the translation of policies and guidelines into practical steps, and a pragmatic methodical integrated approach. This course is not about study design or the science per se, but about application.

What is the format of the course?

The course is interactive, in a small group workshop environment. Participants are encouraged to come with questions and ideas. Real-life research proposals that can be worked on during the workshop are useful, but not essential.

Who are the facilitators?

CREDE is known for its customized and interactive courses in, amongst others, GCP, GDP and consultancy work with clinical research sites. The facilitators have ground-level experience combined with in-depth knowledge and are proficient in this style of training.

What about cost and logistics?

The course is run over two and a half days. Lunch and tea is included.

Participants have the option of combining this course with the Participant Safety Management Module on the afternoon of the third day.

 CPD points and a certificate of attendance will be issued (useful for CVs). Cost: R4 660.00 VAT inclusive

For further information and to book your place (limited spots available!) contact Marijke or Hennie Geldenhuys (marijke@crede.co.za, henniegel@crede.co.za), tel 0832853473.

 

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GCP Beginner

January 4, 2012

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The course is presented over 2 days and ends with a written test. Passing score for a MCC recognized certificate is 70%.

Cost:  R3950 (2017 -Jan 2018)  R 4300.00 (from Feb 2018),  incl. VAT

Aim

This course will provide you with an overview of clinical research, various concepts of research and introduce you to Good Clinical Practice (GCP) from a local and international perspective. It will further provide an in depth understanding of the Investigator’s competencies and responsibilities as set out in the various guidelines and regulations. The importance of participant protection and valid, credible data within the environment of clinical trials will be highlighted.

Objectives

  • Define clinical research and explain why we perform clinical research.
  • Identify the primary areas of clinical research.
  • Outline the drug development process from idea to post-market with special reference to the various phases of the trials.
  • Name the key role players and their responsibilities in clinical research.
  • Name some of the key events and documents which led to the publication of the various International guidance documents. Focus specifically on the Good Clinical Practice (GCP) E6 document and the standards and ethical principles that guide the conduct of clinical research today.
  • Outline the origins and scope of the SA GCP, 2006, version 2- document.
  • Recognize the differences between the SA GCP document and the ICH GCP E6 document.
  • Identify some important concepts used in clinical research.
  • Discuss the Life Cycle of clinical research.
  • Discuss the steps in the conduct of clinical research.
  • Discuss ongoing Informed Consent, Safety reporting, Data and Safety monitoring and IRB review as the primary methods of protection offered to study participants.
  • Identify the various guidance and regulatory documents that outline the responsibilities of the investigator (MCC, FDA, ICH GCP, SA GCP,EU)
  • Describe the main responsibilities of the investigator as featured in the SA GCP.
  • Identify areas of overlap related to responsibilities with regards to the various role players in the CR process.
  • Clarify the role of the investigator as part of the research team and his/her supervisory role
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GCP Refresher

January 4, 2012

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This is a 1 day course with a maximum of 6 hours teaching time. At the end of the course a written assessment is done which requires a 70% passing score for a MCC recognized certificate.

Cost: R1900 (2017- Jan 2018) R2070.00 (from Feb 2018)  incl. VAT

Aim

This Refresher Course will start by assessing the basic knowledge of the more experienced learner regarding GCP. The SA GCP guidelines as well as the ICH GCP will be re-introduced to the learners. In particular, the Investigator’s competencies and responsibilities, as set out in the various guidelines and regulations will be highlighted.

It will further recap concepts around:

  • the history of GCP,
  • ethical and regulatory guidelines and documents in clinical research.
  • drug development
  • stakeholder roles and responsibilities
  • participant protection
  • safety reporting (AE’s, SAE’s, SUSAR)
  • essential documents

Objectives:

  • List the key international guidelines that were adopted and followed as part of the South African guidelines for the conduct of clinical research.
  • Identify the key stakeholder(s) responsible for ensuring that research is performed and data generated in compliance with GCP guidelines and other applicable regulations.
  • Discuss the phases of the clinical research process and the sequence of regulatory and ethical approvals required before initiating a trial.
  • State the protections given to human participants in clinical research focusing on the Informed consent process and safety reporting.
  • Define essential documents for the conduct of the clinical trial with specific focus on source documents, study contracts and agreements, the Investigator’s Brochure and the clinical study report.
  • Identify the various guidance and regulatory documents that outline the responsibilities of the investigator (MCC, FDA, ICH GCP, SA GCP etc.)
  • Describe the main responsibilities of the investigator
  • Clarify the role of the investigator as part of the research team and his/her supervisory role
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Custom Courses

January 4, 2012

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Cost: To be negotiated

These courses include training in important aspects and best practices of clinical research that are not necessarily covered by GCP guidance alone. The courses can be customized to any level of staff e.g. basic entry-level for lay field workers, intermediate level for study coordinators or research nurses, or advanced for PIs or sub-Investigators.

If your site has a particular need or gap CREDE can tailor make a course to fit your needs.

Some examples of these courses:

  • Good documentation practice (GDP): training in designing, completing and quality control of study documentation such as source documents and CRFs
  • Quality Management including Quality Assurance and Quality Control systems, the Quality Management Plan, the Corrective Action Preventative Action plan (CAPA), and much more
  • Informed consent: in-depth training in taking informed consent including special circumstances such illiterate participants, language disparities and translators, underage participants etc.
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