MCCCD Official Course Competencies:

CRC120  2009 Summer I - 2012 Summer II

Introduction to Clinical Research

1.

Define a minimum of 100 common research terms. (I)

2.

Identify correct terminology for 50 research abbreviations and acronyms. (I)

3.

Explain the regulatory progression of protection of human subjects in clinical research as it relates to historical research events. (II)

4.

Describe how the basic ethical principles of human subject research are implemented under current federal regulations. (III)

5.

List the major federal and state regulatory agencies governing human subject research. (IV)

6.

Identify professional research associations and their respective roles. (IV)

7.

Explain basic study designs for human subject research. (V)

8.

List the federally required and optional basic elements of an informed consent form (ICF). (VI)

9.

Identify the major Code of Federal Regulations (CFR) sections that govern human subject and clinical trial research. (VII) 10 Prepare a clinical research team organizational chart. (VIII) 11 Define and roles and responsibilities of the clinical research team as they relate to the clinical research process and development phases I-IV. (VIII, IX)

10.

Describe the roles and responsibilities of various research organizations involved in the clinical research process. (X)

11.

Compare and contrast the Good Clinical Practice (GCP) and International Committee on Humanization (ICH) guidelines. (XI)

12.

Summarize the developmental research phases I-IVB. (XII)

MCCCD Official Course Outline:

CRC120  2009 Summer I - 2012 Summer II

Introduction to Clinical Research

I. Research Terminology and Definitions

A. Common Research Definitions

B. Abbreviations

C. Acronyms

D. Common Rule Definition and Application

E. Basic Ethical Research Principles

II. Human Subject Research and Ethical Considerations

A. Historical Case Studies

B. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research

C. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

III. Development of Ethical Research Principles, Regulations and Guidelines

A. Nuremburg Code 1949

B. National Research Act 1974/81 (DHHS 45CFR46)

C. Declaration of Helsinki 1975

D. Belmont Report 1979

E. FDA (21CFR50/56)

IV. Development of Institutional Review Boards and Data Safety Monitoring Boards

A. Department of Health and Human Services (DHHS)

B. Office of Human Research Protection (OHRP) - Federal Research Oversight

C. Institutional Review Board (IRB)

1. Roles

2. Responsibilities

3. Membership

D. Data Safety Monitoring Board (DSMB)

1. Roles

2. Responsibilities

E. Clinical Research Approval Processes

1. Types

2. Organizational structure

V. Basic Designs and Formats of Human Subject Research

A. Quantitative methodologies

B. Qualitative methodologies

C. Descriptive designs

1. Longitudinal

2. Cross-sectional

3. Other

D. Correlational Designs

1. Predictive

2. Module testing

3. Other

E. Quasi-experimental

1. Control group

2. Interrupted time series

3. Other

F. Experimental

1. Randomized

2. Factorial

3. Crossover

4. Other

G. Non-traditional

1. Primary prevention

2. Health promotion

3. Meta-analysis

VI. Informed Consent Regulations

A. Federal and International Regulations

B. Required Elements of Informed Consent Form (ICF)

C. Local IRB Sample Wording/Requirements

D. Grade Level Wording

E. Examples

1. Correct ICF

2. Incorrect ICF

VII. Roles and Responsibilities of Federal and State Regulatory Agencies for Research

A. Office of Inspector General

B. Office of Human Research Protections

C. National Institutes of Health/ Department of Health & Human Services

D. Federal Drug Agency

E. State Applicable Regulations

VIII. Research Team

A. Team Members

1. Principal Investigator (PI)

2. Co-PI

3. Sub-PI

4. Medical Officer/Writer

5. Clinical Research Coordinator (CRC)

6. Technicians

7. Research Pharmacist

a. Statistician

b. Regulatory manager (monitor/auditor)

8. Data Manager

9. Scientific Writer/Publisher

B. Roles and Responsibilities

C. Organizational Structure

IX. Skills and Attributes of the Clinical Research Professional

A. Demeanor

B. Knowledge and Experience

C. Communication Skills

D. Attention to Detail

E. Affiliation with Professional Research Associations and Respective Roles

1. Society of Clinical Research Associates

2. Association of Clinical Research Professional

3. Drug Information Association

4. Regulatory Affairs Professional Society

5. Institutional Review Board Forum-internet

X. Roles and Responsibilities of Research Organizations and Participants

A. Pharmaceutical Companies

B. Biotech and Medical Device Companies

C. Contract Research Organizations (CRO)

D. Site Management Organizations (SMO)

E. Community Clinical Oncology Programs (CCOPS)

F. Data Safety Monitoring Board (DSMB)

G. Funding Entities

H. Institutional Research Organizations/Investigative Sites

I. Research Subjects and Significant Others

J. Community

K. Academic Institution

L. Multi-sites

M. Independent

N. Cooperatives

O. International

P. Research Laboratories

XI. Good Clinical Practice (GCP) and International Committee on Harmonization (ICH) Guidelines

A. Historical Development

B. Guideline Review

1. GCP

2. ICH

C. International verses US Research Guideline Differences

D. Standard Operating Procedure Guidelines

E. Current US & International Issues

XII. Clinical Trial Development Phases

A. Defining phases

1. Phase I – Phase IV

2. Post marketing

B. New Drug Development and Marketing Approval Process

C. Special Development Considerations

1. Drug

2. Device

3. Biologic

4. Radio-logic

D. Clinical Trial Originations

1. Federal

2. Sponsor

3. Principal Investigator

4. World Health Organization