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 a successful when all the data has being collected from the sites and is accurate before the drug can go onto the market.
Aims The practical course in unique as this was written by a Study co-ordinator for study co ordinators and Doctors.
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 Study co-ordinator is such a vital member of the research team.
Most studies fail or succeed depending on the quality of the Study co-ordinators skills.
The primary responsibility of the study co-ordinator is to manage all aspects of conducting clinical trials at the site.
The study co-ordinator is required to have knowledge of good clinical practices, set forth in GCP, according to the local and international regulations.
The study co-ordinator serves as the primary liaison between the sponsor, the Investigator, and the study subjects.
Each study co-ordinator is evaluated through the feedback and revision on the practical course material done.
Objectives
— Enable you to run the study efficiently, and effectively,
— And a system that will work at the site.
— Enable you to recruit and retain more patients
— Run the Site at optimum efficiency
— Gain you more studies
— Gain international recognition for efficient and accurate data.
— Pass audits
— Have compliant, safe and loyal patients and patients that can finish there visits until the end of the study.
— The Study co-ordinator 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 .