Requirements
-
Although no specific knowledge is necessary, this course is recommended for science, medical or nursing professionals or recent graduates
Module 1 | Clinical Research | |
---|---|---|
Unit 1 | 1. Introduction to Clinical Research & Good Clinical Practice | |
Unit 2 | 2- Overview ICH GCP | |
Unit 3 | 3. Good Clinical practice | |
Unit 4 | 4. Clinical Trails | |
Unit 5 | 5. Institutional Reviews board | |
Unit 6 | 5. Institutional Reviews board | |
Unit 7 | 6. Investigation Responsibilities in clinical trails | |
Unit 8 | 7. Roles and Responsibilities of Sponsor & Clinical Trial Monitor | |
Unit 9 | 8. Informed Consent Process | |
Unit 10 | 9. Serious Adverse Event (SAE), Adverse event reporting | |
Unit 11 | 10. Site Initiation visit | |
Unit 12 | 11. Site close visit | |
Unit 13 | Test Your Self | |
Unit 14 | Apply Your Certificate |
This course on Clinical Research Terminology is designed to provide a thorough understanding of the fundamental concepts, processes, and regulatory aspects of clinical trials. It serves as an essential foundation for anyone involved in or aspiring to work in the field of clinical research.
The course is particularly valuable for a wide range of professionals, including clinical research coordinators, investigators, research nurses, data managers, regulatory affairs specialists, and even students pursuing careers in healthcare or pharmaceutical sciences. It's also beneficial for healthcare professionals who want to better understand the clinical trial process and how it impacts patient care and medical advancements.
The curriculum covers an extensive range of topics, starting from basic definitions to complex regulatory requirements. It delves into crucial areas such as study design, ethical considerations, safety monitoring, data management, and quality control. By exploring terms like adverse events, blinding, randomization, and informed consent, participants gain a comprehensive understanding of the entire clinical trial process.
One of the primary objectives of this course is to establish a common language among all stakeholders in clinical research. This shared understanding is crucial for effective communication, which is vital in ensuring the safety of trial participants and the integrity of research data. The course emphasizes the importance of standardized terminology in maintaining consistency across different trials, sites, and even countries.
Furthermore, this course provides insights into the roles and responsibilities of various entities involved in clinical trials, such as sponsors, investigators, ethics committees, and regulatory authorities. This knowledge is crucial for understanding the complex interplay between different stakeholders and how their actions collectively ensure the ethical and scientific validity of clinical studies.
The course also addresses the critical aspects of patient safety and data integrity. By covering topics like adverse event reporting, monitoring procedures, and quality assurance, it equips learners with the knowledge to contribute effectively to the safe and ethical conduct of clinical trials.
An important aspect of this course is its focus on regulatory compliance. With detailed explanations of Good Clinical Practice (GCP) guidelines, regulatory inspections, and documentation requirements, participants learn how to navigate the complex regulatory landscape of clinical research.
The practical applications of this knowledge are numerous. Participants will be better prepared to read and interpret clinical trial protocols, understand the importance of proper documentation, contribute to the informed consent process, and participate in various aspects of trial conduct and management.
In conclusion, this Clinical Research Terminology course is an invaluable resource for anyone looking to enter or advance in the field of clinical research. It provides a solid foundation of knowledge that is essential for understanding the complex world of clinical trials, ensuring ethical practices, maintaining regulatory compliance, and ultimately contributing to the advancement of medical science and patient care. By mastering this terminology, participants will be well-equipped to engage effectively in clinical research activities and contribute to the development of new treatments and therapies.
Module 1 | Clinical Research Terminology Introduction | |
---|---|---|
Unit 1 | Part -1 | |
Unit 2 | Part-2 | |
Unit 3 | Part-3 | |
Unit 4 | Quiz |
Module 1 | Introduction to Clinical Data Management | |
---|---|---|
Unit 1 | 1. Introduction To Clinical Data Management | |
Module 2 | Clinical Data Management | |
Unit 1 | CDMS | |
Module 3 | Medical Coding in Clinical Data | |
Unit 1 | Medical Coding And Medical Dictionaries | |
Module 4 | Clinical Data Process | |
Unit 1 | 4. Data Capture | |
Unit 2 | 5. Data Collection | |
Unit 3 | 6. Data Validation | |
Unit 4 | 7. Lab Data Management | |
Unit 5 | 8. Query Management | |
Module 5 | Case Report Form | |
Unit 1 | 9. Electronic Case Report Form | |
Module 6 | Quality & Regulatory System | |
Unit 1 | 11. Regulatory Systems | |
Module 7 | Online Examination | |
Unit 1 | Quiz |
Module 1 | 1. Introduction to pharmacovigilance | |
---|---|---|
Unit 1 | Introduction to Pharmacoviginalce | |
Unit 2 | The history of PV | |
Unit 3 | The Burden Of Adrs And The Need For Pv | |
Unit 4 | Aims Of Pv | |
Unit 5 | The Scope Of Pv Part 1,2,3 | |
Module 2 | 2. Signal detection and causality assessment | |
Unit 1 | What Is A Signal, When Does Signal Detection Start & Why Do We Need Signal Detection | |
Unit 2 | Where Can We Find Signals, What Triggers A Signal, How Do We Assess A Signal | |
Module 3 | 3. Statistical reasoning and algorithms in pharmacovigilance | |
Unit 1 | Statistical Reasoning And Algorithms In Pv, Dis-proportionality, Relative Reporting Ratio (Rr) | |
Unit 2 | Random Variability, Decision Rules,Aspects Of Strength Of Evidence, A Cautionary Note | |
Module 4 | Medical Dictionary for Drug Regulatory Activities (MedDRA) | |
Unit 1 | Medical Dictionary for Drug Regulatory Activities (MedDRA) | |
Module 5 | Individual Case Safety Reports (Icsrs) | |
Unit 1 | Individual Case Safety Reports (Icsrs) | |
Module 6 | Periodic safety update report (PSUR) | |
Unit 1 | Periodic safety update report (PSUR) | |
Unit 2 | Dsur Vs Psur in Pharmacovigilance | |
Module 7 | Online Examination | |
Unit 1 | Quiz |
Module 1 | COVID-19 Key Features and PPE | |
---|---|---|
Unit 1 | 1. Covid-19 Key Features | |
Unit 2 | 2. Ppe And Scene Safety | |
Module 2 | Clinical Assessment of COVID-19 Patients | |
Unit 1 | 3. Approach To The Sick Patient | |
Unit 2 | 4. Shock Evaluation At The Bedside | |
Module 3 | Diagnostic Assessment of COVID-19 Patients | |
Unit 1 | 5. Ultrasound In Covid-19 | |
Unit 2 | 6. Assessing The Dyspneic Patient - Clinical | |
Unit 3 | 7. Assessing The Dyspneic Patient - Diagnostic | |
Module 4 | Early Treatment of the Dyspneic COVID-19 Patient | |
Unit 1 | 8. Treating The Mildly Dyspneic Patient | |
Unit 2 | 9. Treating The Moderately Dyspneic Patient - Part 1 | |
Unit 3 | 10. Treating The Moderately Dyspneic Patient - Part 2 | |
Module 5 | Advanced Treatment of the Severely Dyspneic COVID-19 Patient | |
Unit 1 | 11. Treating The Severely Dyspneic Patient - Part 1 | |
Unit 2 | 12. Treating The Severely Dyspneic Patient - Procedures | |
Unit 3 | 13. Treating The Severely Dyspneic Patient - Part 2 | |
Unit 4 | 14. Treating The Severely Dyspneic Patient - Part 3 | |
Module 6 | Initial Ventilator Management and Troubleshooting in COVID-19 Patients | |
Unit 1 | 15. Ventilator Management - Part 1 | |
Unit 2 | 16. Ventilator Management - Part 2 | |
Module 7 | COVID-19 Training for Healthcare Workers - Final Online Examination | |
Unit 1 | COVID-19 Training for Healthcare Workers - Final Online Examination. |
Module 1 | Medical Coding ICD-10-CM Training | |
---|---|---|
Unit 1 | Overview -General Guidelines | |
Unit 2 | Chapter 1 - Certain Infectious And Parasitic Diseases A00-B99 | |
Unit 3 | Chapter 2 - Neoplasms C00-D48 | |
Unit 4 | Chapter 3 - Diseases Of The Blood And Blood-Forming Organs | |
Unit 5 | Chapter 4 - Endocrine, Nutritional And Metabolic Diseases | |
Unit 6 | Chapter 5 - Mental, Behavioral, And Neurodevelopmental Disorders F01-F99 | |
Unit 7 | Chapter 6 - Diseases Of The Central Nervous System | |
Unit 8 | Chapter 7 - Diseases Of The Eye And Adnexa H00-H59 | |
Unit 9 | Chapter 8 - Diseases Of The Ear And Mastoid Process H60-H95 | |
Unit 10 | Chapter 9 - Diseases Of The Circulatory System I00-I99 | |
Unit 11 | Chapter 10 - Diseases Of The Respiratory System J00-J99 | |
Unit 12 | Chapter 11 - Diseases Of The Digestive System K00-K95 | |
Unit 13 | Chapter 12 - Diseases Of The Skin And Subcutaneous Tissue L00-L99 | |
Unit 14 | Chapter 13 - Diseases Of The Musculoskeletal System And Connective Tissue | |
Unit 15 | Chapter 14 - Diseases Of The Genitourinary System N00-N99 | |
Unit 16 | Chapter 15 - Pregnancy, Childbirth, And The Puerperium O00-O9a | |
Unit 17 | Chapter 16 - Certain Conditions Originating In The Perinatal Period P00-P96 | |
Unit 18 | Chapter 17 -Congenital Malformations, Deformations And Chromosomal Abnormalities | |
Unit 19 | Chapter 18 - Symptoms, Signs And Abnormal Clinical And Laboratory Findings, Nec | |
Unit 20 | Chapter 19 - Injury, Poisoning And Certain Other Consequences Of External Causes | |
Unit 21 | Chapter 20 - External Causes Of Morbidity V00-Y99 | |
Unit 22 | Chapter 21 - Factors Influencing Health Status And Contact With Health Services | |
Unit 23 | Chapter 22 - Conclusion-22 | |
Unit 24 | Medical Coding ICD-10-CM -Online Examination |
Module 1 | Chapter 1 | |
---|---|---|
Unit 1 | 1. Jobs in Clinical Research-How to Qualify | |
Module 2 | How do you start your Clinical Research job search | |
Unit 1 | 1. Introduction - Get started to qualify for a Job in Clinical Research! | |
Unit 2 | 2. Who is the clinical research professional | |
Unit 3 | 3. Establishing Your starting point | |
Unit 4 | 4. Case studies of failed job applications, lessons learned | |
Module 3 | Building the necessary qualifications and experience | |
Unit 1 | 1. Improving your chances for a job in Clinical Research | |
Unit 2 | 2. Getting aware on what the jobs in clinical research | |
Unit 3 | 3. Getting the right training in Clinical Research | |
Unit 4 | 4. The work experience in Clinical Research | |
Unit 5 | 5. Build your resume as you build knowledge and experience | |
Unit 6 | 6. What are Online Job Applications | |
Unit 7 | 7. Where are the Clinical Research Jobs | |
Module 4 | 4. Summary | |
Unit 1 | 1. Final Summary |
Module 1 | Chapter 1 | |
---|---|---|
Unit 1 | 1. Jobs in Clinical Research-How to Qualify | |
Module 2 | How do you start your Clinical Research job search | |
Unit 1 | 1. Introduction - Get started to qualify for a Job in Clinical Research! | |
Unit 2 | 2. Who is the clinical research professional | |
Unit 3 | 3. Establishing Your starting point | |
Unit 4 | 4. Case studies of failed job applications, lessons learned | |
Module 3 | Building the necessary qualifications and experience | |
Unit 1 | 1. Improving your chances for a job in Clinical Research | |
Unit 2 | 2. Getting aware on what the jobs in clinical research | |
Unit 3 | 3. Getting the right training in Clinical Research | |
Unit 4 | 4. The work experience in Clinical Research | |
Unit 5 | 5. Build your resume as you build knowledge and experience | |
Unit 6 | 6. What are Online Job Applications | |
Unit 7 | 7. Where are the Clinical Research Jobs | |
Module 4 | 4. Summary | |
Unit 1 | 1. Final Summary |
Module 1 | 1. Introduction | |
---|---|---|
Unit 1 | Introduction | |
Module 2 | 2. Pharmacy Abbreviations | |
Unit 1 | Pharmacy Abbreviations | |
Module 3 | 3. Medications | |
Unit 1 | 1. Top 200 Drugs Introduction | |
Unit 2 | 2. Drug Nomenclature Part 1,2 and 3 | |
Unit 3 | 3. Drug Recalls | |
Unit 4 | 4. National Drug Code Numbers | |
Unit 5 | 5. Medications Wrap-Up | |
Module 4 | 4. Pharmacy Math | |
Unit 1 | 1. General Math Review | |
Unit 2 | 2. Lab Essentials | |
Unit 3 | 3. Volumes and Measures | |
Unit 4 | 4. Conversion | |
Unit 5 | 5. Roman Numerals | |
Unit 6 | 6. IV Calculations | |
Unit 7 | 7. Pediatric Dosages | |
Unit 8 | 8. Temperature Conversions | |
Unit 9 | 9. Ratio and Proportion | |
Unit 10 | 10. Alligation | |
Module 5 | 5. Pharmacy Law | |
Unit 1 | 1. Pharmacy Law | |
Unit 2 | 2. Common Pharmacy Acts and Laws | |
Unit 3 | 3. New Drug Application | |
Module 6 | 6. Conclusion | |
Unit 1 | 1. Landing A Job | |
Unit 2 | 2. Summary | |
Module 7 | 7. PTCB Updated Exam | |
Unit 1 | 1. Reimbursement Plans | |
Unit 2 | 2. Therapeutic Equivalence | |
Unit 3 | 3. Transfer of Controlled Substances | |
Unit 4 | 4. Drug Interactions | |
Unit 5 | 5. Restricted Drug Programs | |
Unit 6 | 6. Common Safety Strategies | |
Unit 7 | 7. Hazardous Materials | |
Unit 8 | 8. Beyond Use Dating |
Module 1 | 1. Introduction | |
---|---|---|
Unit 1 | Introduction | |
Module 2 | 2. Pharmacy Abbreviations | |
Unit 1 | Pharmacy Abbreviations | |
Module 3 | 3. Medications | |
Unit 1 | 1. Top 200 Drugs Introduction | |
Unit 2 | 2. Drug Nomenclature Part 1,2 and 3 | |
Unit 3 | 3. Drug Recalls | |
Unit 4 | 4. National Drug Code Numbers | |
Unit 5 | 5. Medications Wrap-Up | |
Module 4 | 4. Pharmacy Math | |
Unit 1 | 1. General Math Review | |
Unit 2 | 2. Lab Essentials | |
Unit 3 | 3. Volumes and Measures | |
Unit 4 | 4. Conversion | |
Unit 5 | 5. Roman Numerals | |
Unit 6 | 6. IV Calculations | |
Unit 7 | 7. Pediatric Dosages | |
Unit 8 | 8. Temperature Conversions | |
Unit 9 | 9. Ratio and Proportion | |
Unit 10 | 10. Alligation | |
Module 5 | 5. Pharmacy Law | |
Unit 1 | 1. Pharmacy Law | |
Unit 2 | 2. Common Pharmacy Acts and Laws | |
Unit 3 | 3. New Drug Application | |
Module 6 | 6. Conclusion | |
Unit 1 | 1. Landing A Job | |
Unit 2 | 2. Summary | |
Module 7 | 7. PTCB Updated Exam | |
Unit 1 | 1. Reimbursement Plans | |
Unit 2 | 2. Therapeutic Equivalence | |
Unit 3 | 3. Transfer of Controlled Substances | |
Unit 4 | 4. Drug Interactions | |
Unit 5 | 5. Restricted Drug Programs | |
Unit 6 | 6. Common Safety Strategies | |
Unit 7 | 7. Hazardous Materials | |
Unit 8 | 8. Beyond Use Dating |