MCCCD Official Course Competencies:

CRC250  2005 Fall – 2012 Summer II

Clinical Research Site Management

1.

Define a minimum of 50 common research site management terms and acronyms. (I)

2.

Describe the application process for the 6 major clinical research grantors. (II)

3.

Describe the seven major operational components for establishing a research site office. (III)

4.

List the Food and Drug Administration (FDA) requirements/guidelines for sites participating in clinical trials. (III)

5.

Analyze a sample research budget including personnel costs, profit margin, and overhead. (IV)

6.

Identify major differences between public and private contracts. (V)

7.

List required components for advertising for clinical trials. (VI)

8.

Develop a sample procedure for the management of a research site that includes a budget and recruitment and marketing methods. (VII)

9.

Explain major quality assurance issues for research site management. (VIII)

10.

Prepare a sample marketing/recruitment advertisement for a clinical trial. (IX)

11.

Discuss three aspects of study conduct that may be evaluated during an audit. (X)

12.

List the basic elements of a study closure. (XI)

13.

Explain the five management principles in relation to a research site. (XII)

MCCCD Official Course Outline:

CRC250  2005 Fall – 2012 Summer II

Clinical Research Site Management

I. Research Site Terminology/Acronyms, Definitions, and Topic Overviews

A. Grants/Major Types of Proposals

B. Contracts and Contract Elements

C. Budgets

D. Accounting

E. Process

1. Improvement

2. Evaluation

F. Audits

G. Marketing

II. The Grants Market

A. History of Public Research Grants in the United States

B. Major Types of Grants/Proposals

1. Private

2. Public

C. Research Grantors

1. Six major research grantors

2. Application process

D. Distribution of Grant Monies

E. Grant Recipients

F. Grant Resources

III. Office Setup

A. Financing

B. Basic Office Costs

C. Company Structure

D. Facility

E. Equipment

F. Personnel

1. Clinical Research Coordinator (CRC)

2. Data input

3. Regulatory

G. FDA and OSHA Research Site Regulations

1. Sample shipping and storage

2. Personnel Requirements

H. Needs for Expansion

IV. Research Study Initiation Process

A. Feasibility Process

B. Protocol Review

C. Cost Estimation

1. Personnel Costs

2. Profit Margin

3. Overhead

4. Study Procedure Costs

D. Standard of Care Requirements

1. Meets standard

2. Does not meet standard

E. Budget Preparation

1. Public - Circular A-510

2. Private

F. Estimation of Subjects Needed

V. Contract Negotiations

A. Contract Formats

1. Public

2. Private

3. 2-3 party

4. Sub-contracts

B. Public Contracts

C. Intellectual Property Issues

D. Analysis of Sample Contracts

VI. Subject Recruitment/Retention

A. Marketing Strategies

B. Recruitment Campaigns and Evaluation

C. Advertisement Development

1. IRB regulatory advertising components

2. Advertisement media formats

a. content differences

b. target audience determinations

D. Database Queries

E. Medical Record Confidentiality

F. Subject Retention Issues

1. Tissue

2. DNA

VII. Research Study Implementation: Management Issues

A. Good Clinical Practices

B. Standard Operating Procedures (SOPs)

C. Source Documents

D. Case Report Form Documentation

E. Research Study Calendars

F. Data submission

1. Electronic

2. Hard copy

G. Equipment Maintenance Logs

VIII. Site Performance Evaluation

A. Quality Assurance Procedures

B. National Standards for Site Accreditation

C. SOP for Continuous Quality Improvement

D. FDA Major Site Audit Issues

1. Record accuracy and maintenance

2. Lack of adequate trained personnel

3. Drug accountability and storage

4. Lack of continuous quality improvement internal reviews/audits

IX. Business Development and Site Marketing

A. Development of Marketing Materials

1. Web site

2. Brochures

B. Professional Networking

C. Investigator Meetings

D. Community Partnering Strategies

E. Preparation of a Sample Marketing/Recruitment Advertisement

X. Sponsor and Regulatory Audits/Monitor Visits Preparation

A. Self Audit Checklists

B. Documentation

1. Format

2. Preparation

C. Scheduling

1. Personnel

2. Equipment

D. Institutional Review Board (IRB) Documentation Onsite

E. Financial and Regulatory vs. Subject Documentation

F. Audit Summation

1. Conference

2. Response

XI. Research Study Closure Procedures

A. Documentation

1. Subject retention

2. Subject disposition

B. Data Confidentiality

C. Article Disposition

1. Equipment

2. Supply

3. Test

D. Research Study Publication Issues

E. Summary Reports

1. Sponsors

2. IRB

XII. Research Site Personnel Management

A. Five Management Principles Relative to a Research Site

1. Planning

2. Organizing

3. Leading

4. Controlling

5. Evaluating

B. Recruitment

C. Training

1. Initial

2. Continuing education

3. Cross-training for multiple diseases

D. Investigator Relationships