This programme has been developed to provide a complete, cost-effective training package for those new to the CRA role or looking to move into this role in the near future. The programme consists of 5 modules which follow on from one another in a logical sequence. Each module is stand alone but together they provide the knowledge of various aspects of the role to enable effective performance as a CRA.
A certificate is awarded for each module and once all five modules have been taken an additional examination is required and then a certificate for completion of the programme is awarded. PharmaSchool has a considerable and growing reputation in the Clinical Research community and the certificate of completion of this programme demonstrates sound knowledge of clinical trials and a commitment to excellence.
ES1 – Introduction to Clinical Research
Getting a new pharmaceutical product to market involves a large amount of investment and a great deal of time. The module introduces the pharmaceutical industry and provides an informative overview of the stages of developing a new pharmaceutical product. The module then looks at the stages involved in the clinical testing of the new product by explaining the different types of clinical trials, the different phases of trials and the personnel involved in clinical research.
ES2 – GCP and Essential Guidelines
There are a wide range of guidelines and regulations in clinical research. This module introduces the background and history to clinical research guidelines and regulations and explains the difference between a guidelines and a regulation. The module progresses by looking in detail at the relevant guidelines and regulations and provides an essential foundation for the CRA.
ES3 - Clinical Trial Designs
There are numerous related components that make up a clinical trial design. These range from the data to capture, the number of patients, randomisation and blinding through to matters such as whether the trial is looking to show equivalence or a difference between treatment groups. This online module goes through the various components and details the various aspects and considerations of each one. The module explains among other matters the difference between parallel group and cross over trials, single, double and triple blinding, sample size considerations, and difference vs non-inferiority.
ES4 – Monitoring
There are numerous tasks that a monitor must be able to fulfil within their role, these range from selecting, initiating, routine monitoring and closing out sites through to managing investigators, building relationships and problem solving. There are a multitide of regulations and guidelines that a monitor needs to be aware of whilst fulfilling their role. This module blends theory together with practical hints and tips to provide an essential course for a new or potential CRA/Monitor.
ES5 – Essential Documents
There is a saying in clinical research that “if it’s not documented it didn’t happen”. This means that documentation is critical to the trial and setting up and maintaining good files is a key part of running and clinical trial. This module covers all the documents required for regulatory purposes along with practical information on the files needed and how to set up and maintain these files. It also covers the requirements for archiving clinical trial documentation.