Training

What is Unique about our training?

㡮 be done on site
衮ds on approach

ᳳistance is offered in problems areas

ﮥ-on-One Training or small groups

ᦴer Training Support

䲡ining designed for specific studies for the site.

 

A clinical trial or study may be applied to any form of planned experimental drug or device which can be used as medical treatment which involves patients. The clinical trial results are based on the limited sample of patients participating in the trial. Clinical trials are necessary before any new drug or medical treatment is available to the general public. A clinical study examines the efficacy and safety, and if the treatment works as well or better as other methods. The outcome of clinical research is that it can benefit and affect thousands of people to receive future improved treatment. This can only be successful when all the data has been collected, verified and accurately analysed before the drug can go onto the market.

 

Ingonogo Co-ordinators also offers Courses, viz. Good Clinical Practice, Good Clinical Practice Refresher, Data capturing and Introduction to clinical research associates training .Courses specific to the site and individual needs can be arranged and offered.

 

Aims

The broad aim of this course is to provide a basis for the scientific and ethical integrity and develop the knowledge, capabilities of management for effective running of the clinical research projects.

 

The course is designed to give guidelines, theory and practical ideas and an insight which can be applied during all stages of running a clinical trial.

 

The practical course in unique as this was written by a Study co-ordinator / CRA for site staff, Doctors, Pharmacists and Junior CRA's. The course is designed to give theory and practical ideas and an insight to running a study at the site (Drs rooms or clinic or Hospital setting).This ensures the standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that data and reporting results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. The success of a study depends on the research team. Most studies fail or succeed depending on the quality of the research team skills.

 

Learning outcome/expectation and Goals

 

The student at the end of the course will be able to:

 

Provide and understanding explanation and be able to discuss or demonstrate the following:

䨥 basic principles and explanations to the background surrounding the history of human experiments and development of Principles of Good clinical practice principles as outlined in the ICH-GCP guidelines and South Africa Good Clinical Practice guidelines and Declaration of Helsinki.

ಯtocol designs and phases of trials

浮ctions of a protocol

लug development phases and the drug brochure

⥳ponsibilities of the ethics committees , Sponsor, Investigator and site staff

䨥 Informed consent process

㯭pensation for trial related injury to source and scope of liability.

峳ential documents requirements.

䡴a management process including case report form and use of electronic systems and source documents

㡦ety assessments and reporting

鮶estigational product.

ಥ-study, initiation, close out and routine monitoring requirements by the sponsor.

ᵤiting requirements as to the preparation

䩳cuss and determine the challenges in the recruitment planning of patients.

篯d laboratory practice and requirements.

Უhiving of documents

 

 

Learning plan and objectives The student at the end of the course will be able to:

 

Discuss and understanding the use of acronyms in the section of "The language of Clinical Research"

  1. Provide an explanation and background surrounding the history of human experiments and development of Principles of Good clinical practice principles as outlined in the ICH-GCP guidelines and South Africa Good Clinical Practice guidelines.
  2. Discuss the basic principles of the Declaration of Helsinki.
  3. Provide an understanding of the standardized laws and guidelines set forth by the ICH-GCP guidelines and South Africa Good Clinical Practice guidelines.
  4. Provide a background of the responsibilities, composition, functions and operation of the different ethics and regulatory committees.
  5. Understand and be able to explain the different protocol designs and phases of trials and the key topics and functions of a protocol and the drug development phases.
  6. Provide a background and demonstrate an understanding what are the requirements of the Site infrastructure are for example medical equipment required, office space.
  7. Provide an understanding of the requirements of the delegation of duties and responsibilities for the duration of the trial.
  8. Discuss the principles of the Informed consent as described in the declaration of Helsinki, ICH-GCP and South African Good Clinical Practice guidelines.
  9. Discuss and identify the key elements of the informed consent process and requirements for the legal age groups, special cases, children, emergency cases, psychiatric, mentally ill, literacy, legally acceptable representatives, elderly subjects.
  10. Discuss and provide a background to clinical trial insurance with respect to compensation for trial related injury to source and scope of liability, claims and ABPI guidelines.
  11. Discuss and provide the understanding and identify Essential documents requirements.
  12. Discuss and be able to demonstrate and implementation and ability in completion of a source document requirements including the responsibilities associated with the investigator's.
  13. Discuss the management and demonstrate ability in completion of Case report forms and electronic source.
  14. Provide and ensure an understanding of the data management process.
  15. Define safety aspects for example adverse events, and serious adverse events, And expected and unexpected adverse events and differentiate between the seriousness and event intensity and the assessment of causality of the investigational product to the adverse event.
  16. Discuss the responsibilities and obligations of the investigator's and sponsor's reporting of the serious adverse events or adverse events.
  17. Discuss and provide the requirements for the investigational product packaging, labelling, storage, distribution, recollection and returns, destruction and documentation.
  18. Demonstrate an understanding of the pre-study, initiation, close out and routine monitoring requirements by the sponsor.
  19. Discuss and provide a background to the auditing requirements as to the preparation and steps taken during and after the auditing process.
  20. Discuss and determine the challenges in the recruitment planning of patients.
  21. Discuss and demonstrate the understanding of good laboratory practice and requirements.
  22. Provide the background on the different aspects of the site administration requirements for example standard operating procedures.
  23. Provide and understanding of Archiving of documents
  24. Demonstrate an understanding of sources document, case report, adverse event, investigational product reporting, in a workshop activity case study.
  25. Demonstrate an understanding of the different programs used in electronic systems in the case report workshop activity case study.

 

Site point of view after training

Enable you to run the study efficiently, and effectively

  1. Have systems in place which work at the site and is study specific
  2. Enable you to recruit and retain more patients
  3. Run the Site at optimum efficiency
  4. Gain you more studies
  5. Gain international recognition for efficient and accurate data.
  6. Pass site audits
  7. Have compliant, safe and loyal patients and patients that can finish their visits until the end of the study.
  8. The Study co-ordinator / Site Staff and the CRA will become confident , motivated, ability to plan, prioritizing of issues, gain administrative skills, and be able to work independently but also part of a team.

Training Dates

Training dates on request

Note: training can be given on REQUEST on ANY days at the site. Cape Town, Durban, PE, on REQUEST

Two day training: 08:00 - 17:30
One day training: 08:30 - 16:30


Venue Gauteng: 11 Nonna Street, Birchleigh North,
Kempton Park



Bookings Contact:
Karen (Gauteng) -
Cell: 0823298707
wdmickey@worldonline.co.za

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Address: 11 Nonna Street, Birchleigh North, Kempton Park
Telephone: + 27 82 3298 707 Fax: 086 652 7852
Email: wdmickey@worldonline.co.za
© Copyright InGonoGo co-ordinators cc. All Rights Reserved. A Design Media Production.
在这个快速发展变化的时代丰胸产品,人们对所有事情都渐渐失去了耐心丰胸食物,急于求成,对瘦身美容是这样,对丰胸美体更是这样丰胸方法。产后丰胸有用吗丰胸效果