Wednesday 13 July 2011

MIR-IFCR CURRICULUM

MIR Inter - Ed Faculty of CLINICAL RESEARCH

This course is designed to provide students with an understanding of descriptive and research statistics. Students will learn to define, develop and conduct statistical research. Upon successful completion of this course, students shall be able to comprehend statistical terminology, determine statistical and confidence level values, generate descriptive and inferential statistics, test correlation between variables, normalize data distributions, develop component research questions, conduct statistical analysis, formulate statistical hypothesis, define appropriate population, samples, variables and collect and measure data.

CRET 170 - Ethical Considerations in Clinical Research
The efficacy and safety of a new drug is demonstrated by phase I to IV Clinical Trials. GCP is an ethical and scientific quality standard for the design, conduct performance, monitoring, auditing, recording, analysis and reporting of Clinical Trials. In order to use clinical data internationally as also for registration purposes, all clinical trials must conform to GCP standards. This course provides in detail the principles and practices for conduct of a Clinical Trial.
The main aim of this course is to introduce the student to sort out practical issues in ethics he/she will encounter in the field, lab and clinical practice. The course focuses on actual cases rather than on principles and hypothetical situations. Students will examine cases from the real world of clinical research. This course will not provide the student with a set of "correct answers" to ethical issues in medical research. Instead, the goal of this course is to equip the student to identify an ethical issue as and when it arises in the practice of clinical research, and the appropriate regulations and guidelines to follow in such situations.

CREC 126 - Epidemiology in Clinical Research
The course is broadly divided into three major areas.
Basic Epidemiology and observational methods.
Interventional and randomized controlled trials.
Clinical Epidemiology and evidence-based medicine.
Each section of the course will culminate in a short examination. Section 1 will cover concepts of association and outcome, introduce standard epidemiological concepts of incidence and prevalence, define and describe relative risk, absolute risk, attributable risk and various methods for calculating those quantities in different observational research designs. Definitions and methods for reducing bias and confounding are major components of this section. The second session introduces interventional trials, including phase1 and phase2 drug trials, the importance and effects on randomization and the analysis and interpretation of controlled trials. The methods for comparing results of trials, as well as an introduction to non-standard trial designs are provided. The final section of the course introduces the students to the concepts of clinical Epidemiology including evidence of space medicine, interpretation of diagnostic tests, construction and use of clinical prediction rules and evaluation of screening for chronic diseases.


CRRM 190 - Research Methodology
This course provides comprehensive introduction to Clinical Research process, its history and evolution. Topics include, the phases of clinical trials, protection of human subjects, role of clinical research teams, and responsibilities of clinical research organizations. Upon completion, students should be able to prepare an organizational chart depicting a typical research team, defining the roles or responsibilities of each member.
This course introduces students to the scientific development of research protocols and their key elements. Topics include differentiation between research design types, rules for writing protocols, ethical considerations relative to research protocols and the methodology for preparation of data collection forms. Upon completion, students will be able to identify the primary components of protocols and effectively develop a protocol draft.


CRCA 104 - Computer Application
The course is designed and intended to provide research scholars through knowledge on advanced database management systems. Scholars would be able to create a conceptual scheme based on specified data requirements and to design a logical database based on the same. Topics include functional dependancy and normalization, entity/relationship diagrams, data protection etc.
The Scholar will also be introduced to relational database concepts. Topics covered include creating database, adding, displaying and editing records, data queries, sorting and indexing files, creating forms and report using built in "wizards".

CRPM 125/135 - Project Management-Planning and Control
This course will introduce scholars to the fundamentals of Project Management. It is designed to develop an understanding of the traditional and modern applications of Project Management methodology. Topics covered include projects in business and technical environments, project development and basic knowledge required for the effective management of projects with specific focus on the clinical research industry. The Guide to the Project Management Body of Knowledge (PMBoK), published by Project Management(PMI), is being used as the primary text for this course.
This course introduces research scholars to the challenges involved in implementing and managing a clinical study. Topics include overall Project Planning, Development of study goals, Preparation of Budgets and Contracts, Implementing and Monitoring visits, Effective Management of Research Sites, Strategic Planning, Developing Project Charter, and Project Scope including Basic and Advanced Techniques used to develop Work Breakdown Structures (WBS). The course also highlights the Strategic importance of Project Milestones and the Determining of Project Phases. Upon completion, the scholar would be in a position to design and prepare a plan for the implementation and management of a Clinical Research Project. Through theoretical and practical examples, the scholar will learn the skills and techniques used for planning projects. 

CRP 1248 - Clinical Practicum
Upon completion of the theoretical portion of the program, research scholars will be provided opportunities to work in a clinical environment to gain practical experience and to apply the theoretical skills learned. The practical part is a formal component of the program and will be separately evaluated. Scholars will also undergo the Continuing Research Education Program (CREP) while they undertake their Clinical Practicum and will be awarded credits both for the internship and the CREP, before taking the final qualifying exam.








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