CRA education – Clinical Research Associate
- Education lasts two semesters (October-April)
- Lectures are held on Wednesdays, Thursdays and Fridays after working hours
- It is intended for doctors, pharmacists, dentists and other health professionals
- The number of places is limited to 15 participants
- Applications are open from the beginning of the year until September of the current year
- Online teaching is also possible
Week 1: Introduction – the role of CRA in clinical trials
Week 2: Discovery and development of new pharmaceutical preparations
Week 3: Fundamentals of Clinical Pharmacology
In the first weeks of education, you will get acquainted in detail with the way of conducting clinical studies. You will be introduced to the life cycle of a drug; types of studies.
Week 4: Regulatory Basis of Clinical Research I
Week 5: Regulatory Basis of Clinical Research II
Clinical studies are strictly regulated by law. At the Academy you will learn all about the legal requirements for conducting clinical studies both at the local level and at the EU and US levels.
Week 6: Conducting clinical trials, general remarks
Introduction to general terms used in clinical studies.
Week 7: Ethics and documentation
Adherence to all ethical principles is crucial for conducting a clinical study. At the Academy, you will be introduced to the acts on which the ethics of testing new drugs is based.
Clinical studies require that everything is documented appropriately. Therefore, getting acquainted with the names, types and purpose of each document used during the study is necessary for conscientious and responsible work within the CRO company. After this lecture you will be able to clearly distinguish all the documents and sets of documents that confuse many employees.
Week 8: Good Clinical Practice – basics
Knowledge of ICH GCP is a requirement for every employee in the clinical study industry. GCP is an internacional, scientific and practical standard according to which all clinical studies are conducted.
Week 9: Monitoring I – Feasibility, Evaluation of the center
Week 10: Monitoring II – Initiation of the center, Monitoring of visits
Week 11: Monitoring III – Monitoring of visits, Close out of the center
Week 12: Monitoring IV – Finishing the study, archiving
Particular importance is attached to monitoring the progress of the clinical study and determining that the study is conducted, documented and reported in accordance with the prescribed protocol, standard operating procedures, principles of good clinical practice and legal requirements. This act is called monitoring and the person responsible for this function is the Clinical Research Associate (CRA).
The CRA Academy envisages 4 weeks of lectures related to monitor responsibilities as well as to explain how monitoring takes place. Lectures include preparation, implementation and reporting on monitoring visits. During the lecture you will be informed in detail about what is expected from the monitor.
- SOFT SKILLS lectures are held every Wednesday during the first semester.
Week 1: Fraud and Misconduct; Audit and Inspection
Prevention, detection and resolution of any (un)intentional error, non-compliance and fraud of any member of the study implementation/ monitoring team is one of the crucial roles of the monitor – CRA. Our lecturers will present you the most common cases from practice as well as advice on how to act in a particular situation. Audit and inspection of the study are an integral part of one study. The auditor and inspector of the study are independent persons in charge of verifying the reliability of the collected data and determining the regularity of the study. The advice of the lecturers, who themselves work as Auditors, will help you prepare for this, for many a stressful process, and avoid all possible potential difficulties and complications.
Week 2: Basics of Project Management I
Week 3: Basics of Project Management II
The position of Project Manager requires previous work experience in the field of clinical studies. During the two – week lecture, the lecturer will instruct you in all the responsibilities and obligations of the person in this position. You will gain insight into the ways of organizing a team for monitoring a clinical study within a CRO company as well as the ways and methods for forming a study budget.
Week 4: Statistics and Data Processing I
Week 5: Statistics and Data Processing II
Statistics are needed to predict the potential number of patients who should participate in the study in order to obtain statistically significant data. Data collected during a clinical study must be subjected to statistical processing in order to be used for further development or registration of the drug. Statisticians also help create a randomization list – a list of assigning therapies to patients, in the case of randomized study.
Week 6: Recruiting patients
Patient enrollment is one of the main problems of any clinical study. Almost 30% of phase III studies are canceled or stopped due to difficulties in involving/recruiting patients. There are several ways to overcome this problem.
Week 7: Pharmacovigilance I
Week 8: Pharmacovigilance II and III
Monitoring of adverse events (AE) and suspected unexpected serious adverse drug reactions (SUSAR) is crucial and mandatory in a clinical study. It is the responsibility and obligation of each project employee to adequately deal with any adverse events during the study, which includes reporting to the sponsor and regulatory authorities to assess the event and determine its possible impact on the further course of the study. A lecturer with many years of experience in this field of clinical studies will present and explain the way pharmacovigilance works in clinical studies.
Week 9: Practical teaching
- Every Wednesday during the second semester lectures and exercises on electronic data entry systems in clinical trials are held – Electronic Data Capture (EDC) Systems