"Research is 'creative and systematic work undertaken to increase the stock of knowledge'."
The ethical considerations of conducting and participating in clinical research, including informed consent, risk-benefit assessment, and protection of vulnerable populations.
Introduction to Clinical Research: This includes the basic principles, purpose, and types of clinical research.
Research Ethics: This topic covers the ethical considerations and guidelines involved in conducting human research, the role of the Institutional Review Board (IRB), and other regulatory bodies.
Study Design: This topic includes the different types of study designs, such as observational, interventional, randomized controlled trials (RCTs), and the strengths and limitations of each.
Informed Consent: This topic relates to the process of obtaining informed consent from study participants, including the legal and ethical requirements for informed consent.
Data Management and Analysis: This topic covers the basic concepts of data management, including data cleaning, storage, analysis, and interpretation.
Clinical Trial Operations: This topic includes the practical aspects of clinical trial operations, such as site selection, recruitment, and monitoring.
Good Clinical Practice (GCP): This includes the international standard for conducting clinical trials, including the principles of GCP and the responsibilities of researchers, clinical investigators, and sponsors.
Regulatory Affairs: This topic covers the regulatory aspects of clinical research, including the approval process for drugs and medical devices, and the role of regulatory agencies such as the FDA.
Medical Writing: This topic includes technical writing such as protocol writing, and scientific communication in the form of academic papers, abstracts, posters, and presentations.
Medical Statistics: This topic is concerned with the application of statistical analysis to clinical research data to enable informed decisions.
Pharmacovigilance: This topic includes the monitoring of drug safety after clinical trials, and the reporting of adverse events that occur during the clinical trial.
Quality Assurance: This topic includes the process of ensuring that clinical studies’ quality requirements are met.
Health Economics: This topic includes the analysis of the financial impact of healthcare interventions.
Bioethics: This topic covers the ethical principles that govern issues in medicine, including confidentiality, privacy, and end of life.
Epidemiology: Involves the study and analysis of disease patterns among populations.
Health Care Management: This topic encompasses managing healthcare organizations, healthcare policies, and healthcare systems.
Protocol development: Writing a comprehensive protocol is crucial in ensuring that all aspects of a study are outlined and can be executed.
Biostatistics: It involves the application of statistical analysis to biological and medical data to discover meaningful insights.
Healthcare research methods: This topic covers the various methods used to conduct research in the field of health care.
Academic writing and publishing: Involves the process of publishing academic research while ensuring it is accurate, relevant, and useful to the readers.
Observational studies: These studies observe and collect data on subjects without any intervention or treatment. They are used to gather information about a particular condition's natural course and risk factors.
Cross-sectional studies: These studies collect data on a group of subjects at a single point in time. They are used to estimate a population's prevalence of a particular condition.
Case-control studies: These studies compare individuals with a particular condition (cases) with those without the condition (controls). They are used to investigate potential risk factors for the condition.
Cohort studies: These studies follow a group of subjects over time to see how often a particular condition occurs and what factors may increase or decrease the likelihood of developing the condition.
Randomized controlled trials (RCT): These studies randomly assign subjects to receive either a treatment or a placebo. They are used to determine the safety and efficacy of a particular intervention or treatment.
Phase I trials: These RCTs evaluate the safety and tolerability of a new intervention or treatment in a small group of healthy volunteers.
Phase II trials: These RCTs examine the intervention or treatment's effectiveness, dose, and side effects in a larger group of patients with the target condition.
Phase III trials: These RCTs compare the intervention or treatment to the current standard of care in a large group of patients with the target condition.
Phase IV trials: These trials are conducted after a drug or treatment is approved by regulatory authorities. They monitor the drug's long-term safety and effectiveness in a large, diverse patient population.
Qualitative studies: These studies use open-ended questions and interviews to gather data about patients' experiences, attitudes, and perceptions regarding a particular intervention or treatment. They are used to evaluate patient satisfaction and quality of life.
Systematic reviews and meta-analyses: These studies evaluate and synthesize the results of multiple clinical trials to improve understanding of the benefits and risks of a particular intervention or treatment.
Registry studies: These studies capture patient data in a database over an extended time period to gather information about long-term outcomes and possible adverse events.
Biobanking studies: These studies collect and store biological samples to assess biomarkers related to disease risk, progression, and treatment response.
"It involves the collection, organization and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness to controlling sources of bias and error."
"A research project may be an expansion on past work in the field. To test the validity of instruments, procedures, or experiments, research may replicate elements of prior projects or the project as a whole."
"The primary purposes of basic research (as opposed to applied research) are documentation, discovery, interpretation, and the research and development (R&D) of methods and systems for the advancement of human knowledge."
"Approaches to research depend on epistemologies, which vary considerably both within and between humanities and sciences."
"There are several forms of research: scientific, humanities, artistic, economic, social, business, marketing, practitioner research, life, technological, etc."
"The scientific study of research practices is known as meta-research."
"A researcher is a person engaged in conducting research, possibly recognized as an occupation by a formal job title."
"In order to be a social researcher or social scientist, one should have enormous knowledge of subject related to social science that they are specialized in."
"Similarly, in order to be a natural science researcher, the person should have knowledge on field related to natural science (physics, chemistry, biology, astronomy, zoology and so on)."
"To test the validity of instruments, procedures, or experiments, research may replicate elements of prior projects or the project as a whole."
"...the research and development (R&D) of methods and systems for the advancement of human knowledge."
"It involves the collection, organization and analysis of evidence to increase understanding of a topic."
"It involves a particular attentiveness to controlling sources of bias and error."
"There are several forms of research: scientific, humanities, artistic, economic, social, business, marketing, practitioner research, life, technological, etc."
"Research is 'creative and systematic work undertaken to increase the stock of knowledge'."
"A research project may be an expansion on past work in the field."
"The primary purposes of basic research (as opposed to applied research) are documentation, discovery, interpretation, and the research and development (R&D) of methods and systems for the advancement of human knowledge."
"The scientific study of research practices is known as meta-research."
"A researcher is a person engaged in conducting research, possibly recognized as an occupation by a formal job title."