Clinical Trials I

Title	% from total grade	Grade
1. Self-assessment test.	5.00% from total grade	10 points
2. Self-assessment test	5.00% from total grade	10 points
Reflection after lecture (to be submitted in estudies)
3. Development of research minutes	40.00% from total grade	10 points
Study minutes developed
4. Development of the research minutes method	40.00% from total grade	10 points
A study minutes methodology has been developed.

Title	% from total grade	Grade
1. Self-assessment test - terminology and adherence to principles	10.00% from total grade	10 points
Self-assessment test - terminology and adherence to principles

The history, objectives and importance of experimental research. Description Familiarise students with the historical development, basic principles, objectives and importance of experimental research in healthcare and public health. The lecture highlights the research’s contribution to the development of clinical practice and evidence-based care. To familiarise students with the structure of the clinical trial stages, the objectives of each phase, the involvement of participants and the role in the development of medicinal products or treatments. Lecture provides an understanding of how research phases ensure safe and effective therapies are put into practice.

Clinical trial phases Description To familiarise students with the structure of the clinical trial stages, the objectives of each phase, the involvement of participants and the role in the development of medicinal products or treatments. Lecture provides an understanding of how research phases ensure safe and effective therapies are put into practice.

Main research designs and their choice Description Overview of the main research designs (observation, experimental, cohort, etc.) and their suitability for different research issues.

Randomisation and randomised controlled trials Description The importance, methods and application of randomisation in clinical trials have been explained. A look at the types of randomization and their benefits.

Ensuring control group and comparability Description The role of control groups in scientific design, their choice and possible substitutes in cases where control is not possible.

Blind methods and study masking Description Blind methods (simple, double) and study camouflage strategies are discussed to prevent abnormalities and improve reliability.

Description of the poppolation to be studied Description Complex designs, their benefits and limitations.

Complex and multidimensional research designs Description Complex designs, their benefits and limitations.

Determination of sample size: principles and methods Description Presentation of sampling methods, including capacity analysis and effect size.

Adaptive themes and their application Description Adaptive designs – flexible research plans that adapt to intermediate concepts. Examples and uses in healthcare.

Examples of design: analysis and interpretation (lesson) Description Practical analysis of examples from different research designs, evaluation of them according to research issues.

Examples of design: analysis and interpretation (lesson) Description Calculation of sample circles in different studies.

Evaluation of the design of the research minutes (lesson) Description Discussion and analysis of the choice of different designs in research minutes. Critical evaluation of design structure.

Regulatory authorisations for Clinical Studies Description Regulatory authorisation, receipt and organisation of Clinical Studies

Requirements for drawing up minutes of Clinical Studies Description Development of clinical trial minutes and their requirements

Low intervention Clinical studies

Planning of multinational clinic studies

Non-interventionist Clinical Studies

Statistical analysis plan

Preparing minutes synopsis

Clinical study protocol full version

Ethical aspects of biomedical and clinical research. Principles of the ICH GCP. Description Develop students’ understanding of ethical principles in clinical trials and present the ICH-GCP (good Clinical practice) guidelines as an international standard for ensuring the safety and quality of human-involved research.

Ethical aspects of biomedical and clinical research. Principles of the ICH GCP. Description Develop students’ understanding of ethical principles in clinical trials and present the ICH-GCP (good Clinical practice) guidelines as an international standard for ensuring the safety and quality of human-involved research.

Principles of good clinical practice, ethical dilemmas Description Develop students’ understanding of ethical principles in clinical trials and present the ICH-GCP (good Clinical practice) guidelines as an international standard for ensuring the safety and quality of human-involved research.

The history, objectives and importance of experimental research. Description Familiarise students with the historical development, basic principles, objectives and importance of experimental research in healthcare and public health. The lecture highlights the research’s contribution to the development of clinical practice and evidence-based care. To familiarise students with the structure of the clinical trial stages, the objectives of each phase, the involvement of participants and the role in the development of medicinal products or treatments. Lecture provides an understanding of how research phases ensure safe and effective therapies are put into practice.

Main research designs and their choice Description Overview of the main research designs (observation, experimental, cohort, etc.) and their suitability for different research issues.

Randomisation and randomised controlled trials Description The importance, methods and application of randomisation in clinical trials have been explained. A look at the types of randomization and their benefits.

Ensuring control group and comparability Description The role of control groups in scientific design, their choice and possible substitutes in cases where control is not possible.

Blind methods and study masking Description Blind methods (simple, double) and study camouflage strategies are discussed to prevent abnormalities and improve reliability.

Description of the poppolation to be studied Description Complex designs, their benefits and limitations.

Complex and multidimensional research designs Description Complex designs, their benefits and limitations.

Determination of sample size: principles and methods Description Presentation of sampling methods, including capacity analysis and effect size.

Adaptive themes and their application Description Adaptive designs – flexible research plans that adapt to intermediate concepts. Examples and uses in healthcare.

Examples of design: analysis and interpretation (lesson) Description Practical analysis of examples from different research designs, evaluation of them according to research issues.

Examples of design: analysis and interpretation (lesson) Description Calculation of sample circles in different studies.

Evaluation of the design of the research minutes (lesson) Description Discussion and analysis of the choice of different designs in research minutes. Critical evaluation of design structure.

Regulatory authorisations for Clinical Studies Description Regulatory authorisation, receipt and organisation of Clinical Studies

Requirements for drawing up minutes of Clinical Studies Description Development of clinical trial minutes and their requirements

Low intervention Clinical studies

Planning of multinational clinic studies

Non-interventionist Clinical Studies

Statistical analysis plan

Preparing minutes synopsis

Clinical study protocol full version

Ethical aspects of biomedical and clinical research. Principles of the ICH GCP. Description Develop students’ understanding of ethical principles in clinical trials and present the ICH-GCP (good Clinical practice) guidelines as an international standard for ensuring the safety and quality of human-involved research.