Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| CLINICAL RESEARCHES | - | Spring Semester | 2+0 | 2 | 3 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Elective |
| Course Coordinator | Prof.Dr. Seda ÜNSALAN |
| Name of Lecturer(s) | Prof.Dr. Seda ÜNSALAN, Lect.Dr. Gökçe SÖZER |
| Assistant(s) | |
| Aim | The main goal and objective of this class is to provide pharmacy students the essentials of pre-clinical and clinical research, phase studies, research motifs as well as the situation of clinical research in Turkey, preparation and evaluation of a sample case study preliminary report and prepare with students sample clinical study, and finally investigating dosage finding studies of active pharmaceutical ingredient in clinical research. |
| Course Content | This course contains; 1. General terms and principals in clinical research and pre-clinical research. Ethical committees, preparation of protocols,2. Stages of pre-clinical research for drug development (Phase-0),3. The importance and role of bio-statistic in clinical research.,4. Determination of clinical data and variables, survey procedures, validity and reliability, scientific research planning,5. Research tools and key components in clinical research, bio similarity experiments,6. Phase studies in clinical research (Phase-1 through Phase-IV).,7. İmportant parameters and tools while conducting a clinical study (reliability, audition, data gathering, and evaluation of tolerability),8. Quality in clinical research, sampling, finding co-horts and study subjects, randomization study, blind study methods, selecting control groups and properties of clinical study),9. Sources of mistakes, and bias in clinical research.,10. Ethical committees in clinical research and their function and importance,11. Data analysis of clinical research and complete evaluation of case reports and finalizing the outcome, preparation of final report.,12. Preparation of a sample case study (preliminary draft and preparing a final study and the situation of clinical research in Turkey.,13. Clinical researchs in Turkey.,14. Clinical researchs in Turkey. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| 1.Interpret the definitions of clinical research terms | 12, 13, 4, 9 | A |
| 1.1.Evaluate pre-clinical drug discovery stages | 12, 13, 4, 9 | A |
| 1.2.Classify clinical phase studies | 12, 13, 4, 9 | A |
| 1.3.Compare clinical phase studies | 12, 13, 4, 9 | A |
| 1.4.Contribute on study design for clinical phase studies | 12, 13, 4, 9 | A |
| 2.Formulate the data obtained from clinical studies | 12, 13, 4, 9 | A |
| 2.1.Classify the data | 12, 13, 4, 9 | A |
| 2.2.Evaluate the biostatistical data | 12, 13, 4, 9 | A |
| 2.3.Prepare the final report based on clinical results. | 12, 13, 4, 9 | A |
| Teaching Methods: | 12: Problem Solving Method, 13: Case Study Method, 4: Inquiry-Based Learning, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | 1. General terms and principals in clinical research and pre-clinical research. Ethical committees, preparation of protocols | 1,2 |
| 2 | 2. Stages of pre-clinical research for drug development (Phase-0) | 1,2 |
| 3 | 3. The importance and role of bio-statistic in clinical research. | 1,2 |
| 4 | 4. Determination of clinical data and variables, survey procedures, validity and reliability, scientific research planning | 1,2 |
| 5 | 5. Research tools and key components in clinical research, bio similarity experiments | 1,2 |
| 6 | 6. Phase studies in clinical research (Phase-1 through Phase-IV). | 1,2 |
| 7 | 7. İmportant parameters and tools while conducting a clinical study (reliability, audition, data gathering, and evaluation of tolerability) | 1,2 |
| 8 | 8. Quality in clinical research, sampling, finding co-horts and study subjects, randomization study, blind study methods, selecting control groups and properties of clinical study) | 1,2 |
| 9 | 9. Sources of mistakes, and bias in clinical research. | 1,2 |
| 10 | 10. Ethical committees in clinical research and their function and importance | 1,2 |
| 11 | 11. Data analysis of clinical research and complete evaluation of case reports and finalizing the outcome, preparation of final report. | 1,2 |
| 12 | 12. Preparation of a sample case study (preliminary draft and preparing a final study and the situation of clinical research in Turkey. | 1,2 |
| 13 | 13. Clinical researchs in Turkey. | 1,2 |
| 14 | 14. Clinical researchs in Turkey | 1,2 |
| Resources |
| 1. Beside the following reference book and prepared hand-outs, the instructor will recommend some other sources, and relevant books from library. |
| 2. Clinical Research (Scientific Planning and Analysis Methods) Prof. Kadir Sümbüloğlu, Prof. Vildan Sümbüloğlu, Doç. Dr. Zafer Güney. Hatipoğlu yayınları. ISBN: 975-8322-21-3 |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PQ-1. Skilfully use information technology to access, follow, evaluate and apply current knowledge in the field of Pharmaceutical Sciences. | X | |||||
| 2 | PQ-2. Have advanced knowledge in APIs and DPs. | X | |||||
| 3 | PQ-3. Collaborate with the experts for collection, interpretation, application and declaration of data in Pharmaceutical Sciences field. | X | |||||
| 4 | PQ-4. Provide best patient counseling services and medication therapy management using his/her knowledge and pharmaceutical information systems to improve the quality of life and safety of patient. | X | |||||
| 5 | PQ-5. Capable of organizing and administering a drugstore as per responsibilities prescribed under the Pharmacy Law, using skills, knowledge and advanced technology systems. | X | |||||
| 6 | PQ-6. Skilfully use computer programs and advanced technology related to the Pharmaceutical Sciences. | X | |||||
| 7 | PQ-7. Provide solutions to the professional issues using scientific knowledge and data. | X | |||||
| 8 | PQ-8. Perform identification, quality control and standardization of the drug products. | ||||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | ||||||
| 10 | PQ-10. Capable of conducting independent studies with his/her advanced knowledge in pharmaceutical sciences, takes responsibilities in professional organizations and efficiently collaborates with the members of his/her own organization as well as other organizations. | X | |||||
| 11 | PQ-11. Clearly show signs of adoption of life-long learning and openness to further development. | X | |||||
| 12 | PQ-12. Critically evaluate their knowledge in pharmaceutical sciences. | X | |||||
| 13 | PQ-13. Closely follow and evaluate the national and international professional developments. | X | |||||
| 14 | PQ-14. Record and document all professional activities and applications. | ||||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | ||||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | ||||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | X | |||||
| 18 | PQ-18. Actively involve in the preparation of APIs, every stage of the formulation and production of DPs. | X | |||||
| 19 | PQ-19. Knowledgable in the regulatory rules of new drug application, data protection and patent issues and understand their interrelationship. | X | |||||
| 20 | PQ-20. Have awareness of his/her duties, rights and responsibilities and act based on Pharmacy Law and high professional ethical standards. | X | |||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | X | |||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 40 | |
| Rate of Final Exam to Success | 60 | |
| Total | 100 | |
| ECTS / Workload Table | ||||||
| Activities | Number of | Duration(Hour) | Total Workload(Hour) | |||
| Course Hours | 14 | 3 | 42 | |||
| Guided Problem Solving | 0 | 0 | 0 | |||
| Resolution of Homework Problems and Submission as a Report | 14 | 3 | 42 | |||
| Term Project | 3 | 2 | 6 | |||
| Presentation of Project / Seminar | 0 | 0 | 0 | |||
| Quiz | 0 | 0 | 0 | |||
| Midterm Exam | 0 | 0 | 0 | |||
| General Exam | 0 | 0 | 0 | |||
| Performance Task, Maintenance Plan | 0 | 0 | 0 | |||
| Total Workload(Hour) | 90 | |||||
| Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(90/30) | 3 | |||||
| ECTS of the course: 30 hours of work is counted as 1 ECTS credit. | ||||||
Detail Informations of the Course
Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| CLINICAL RESEARCHES | - | Spring Semester | 2+0 | 2 | 3 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Elective |
| Course Coordinator | Prof.Dr. Seda ÜNSALAN |
| Name of Lecturer(s) | Prof.Dr. Seda ÜNSALAN, Lect.Dr. Gökçe SÖZER |
| Assistant(s) | |
| Aim | The main goal and objective of this class is to provide pharmacy students the essentials of pre-clinical and clinical research, phase studies, research motifs as well as the situation of clinical research in Turkey, preparation and evaluation of a sample case study preliminary report and prepare with students sample clinical study, and finally investigating dosage finding studies of active pharmaceutical ingredient in clinical research. |
| Course Content | This course contains; 1. General terms and principals in clinical research and pre-clinical research. Ethical committees, preparation of protocols,2. Stages of pre-clinical research for drug development (Phase-0),3. The importance and role of bio-statistic in clinical research.,4. Determination of clinical data and variables, survey procedures, validity and reliability, scientific research planning,5. Research tools and key components in clinical research, bio similarity experiments,6. Phase studies in clinical research (Phase-1 through Phase-IV).,7. İmportant parameters and tools while conducting a clinical study (reliability, audition, data gathering, and evaluation of tolerability),8. Quality in clinical research, sampling, finding co-horts and study subjects, randomization study, blind study methods, selecting control groups and properties of clinical study),9. Sources of mistakes, and bias in clinical research.,10. Ethical committees in clinical research and their function and importance,11. Data analysis of clinical research and complete evaluation of case reports and finalizing the outcome, preparation of final report.,12. Preparation of a sample case study (preliminary draft and preparing a final study and the situation of clinical research in Turkey.,13. Clinical researchs in Turkey.,14. Clinical researchs in Turkey. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| 1.Interpret the definitions of clinical research terms | 12, 13, 4, 9 | A |
| 1.1.Evaluate pre-clinical drug discovery stages | 12, 13, 4, 9 | A |
| 1.2.Classify clinical phase studies | 12, 13, 4, 9 | A |
| 1.3.Compare clinical phase studies | 12, 13, 4, 9 | A |
| 1.4.Contribute on study design for clinical phase studies | 12, 13, 4, 9 | A |
| 2.Formulate the data obtained from clinical studies | 12, 13, 4, 9 | A |
| 2.1.Classify the data | 12, 13, 4, 9 | A |
| 2.2.Evaluate the biostatistical data | 12, 13, 4, 9 | A |
| 2.3.Prepare the final report based on clinical results. | 12, 13, 4, 9 | A |
| Teaching Methods: | 12: Problem Solving Method, 13: Case Study Method, 4: Inquiry-Based Learning, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | 1. General terms and principals in clinical research and pre-clinical research. Ethical committees, preparation of protocols | 1,2 |
| 2 | 2. Stages of pre-clinical research for drug development (Phase-0) | 1,2 |
| 3 | 3. The importance and role of bio-statistic in clinical research. | 1,2 |
| 4 | 4. Determination of clinical data and variables, survey procedures, validity and reliability, scientific research planning | 1,2 |
| 5 | 5. Research tools and key components in clinical research, bio similarity experiments | 1,2 |
| 6 | 6. Phase studies in clinical research (Phase-1 through Phase-IV). | 1,2 |
| 7 | 7. İmportant parameters and tools while conducting a clinical study (reliability, audition, data gathering, and evaluation of tolerability) | 1,2 |
| 8 | 8. Quality in clinical research, sampling, finding co-horts and study subjects, randomization study, blind study methods, selecting control groups and properties of clinical study) | 1,2 |
| 9 | 9. Sources of mistakes, and bias in clinical research. | 1,2 |
| 10 | 10. Ethical committees in clinical research and their function and importance | 1,2 |
| 11 | 11. Data analysis of clinical research and complete evaluation of case reports and finalizing the outcome, preparation of final report. | 1,2 |
| 12 | 12. Preparation of a sample case study (preliminary draft and preparing a final study and the situation of clinical research in Turkey. | 1,2 |
| 13 | 13. Clinical researchs in Turkey. | 1,2 |
| 14 | 14. Clinical researchs in Turkey | 1,2 |
| Resources |
| 1. Beside the following reference book and prepared hand-outs, the instructor will recommend some other sources, and relevant books from library. |
| 2. Clinical Research (Scientific Planning and Analysis Methods) Prof. Kadir Sümbüloğlu, Prof. Vildan Sümbüloğlu, Doç. Dr. Zafer Güney. Hatipoğlu yayınları. ISBN: 975-8322-21-3 |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PQ-1. Skilfully use information technology to access, follow, evaluate and apply current knowledge in the field of Pharmaceutical Sciences. | X | |||||
| 2 | PQ-2. Have advanced knowledge in APIs and DPs. | X | |||||
| 3 | PQ-3. Collaborate with the experts for collection, interpretation, application and declaration of data in Pharmaceutical Sciences field. | X | |||||
| 4 | PQ-4. Provide best patient counseling services and medication therapy management using his/her knowledge and pharmaceutical information systems to improve the quality of life and safety of patient. | X | |||||
| 5 | PQ-5. Capable of organizing and administering a drugstore as per responsibilities prescribed under the Pharmacy Law, using skills, knowledge and advanced technology systems. | X | |||||
| 6 | PQ-6. Skilfully use computer programs and advanced technology related to the Pharmaceutical Sciences. | X | |||||
| 7 | PQ-7. Provide solutions to the professional issues using scientific knowledge and data. | X | |||||
| 8 | PQ-8. Perform identification, quality control and standardization of the drug products. | ||||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | ||||||
| 10 | PQ-10. Capable of conducting independent studies with his/her advanced knowledge in pharmaceutical sciences, takes responsibilities in professional organizations and efficiently collaborates with the members of his/her own organization as well as other organizations. | X | |||||
| 11 | PQ-11. Clearly show signs of adoption of life-long learning and openness to further development. | X | |||||
| 12 | PQ-12. Critically evaluate their knowledge in pharmaceutical sciences. | X | |||||
| 13 | PQ-13. Closely follow and evaluate the national and international professional developments. | X | |||||
| 14 | PQ-14. Record and document all professional activities and applications. | ||||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | ||||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | ||||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | X | |||||
| 18 | PQ-18. Actively involve in the preparation of APIs, every stage of the formulation and production of DPs. | X | |||||
| 19 | PQ-19. Knowledgable in the regulatory rules of new drug application, data protection and patent issues and understand their interrelationship. | X | |||||
| 20 | PQ-20. Have awareness of his/her duties, rights and responsibilities and act based on Pharmacy Law and high professional ethical standards. | X | |||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | X | |||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 40 | |
| Rate of Final Exam to Success | 60 | |
| Total | 100 | |