Approved by

Medical Dept Chairperson

1.0

ORGANIZATION

1.1

Description and Structure of the Clinical Research Center

5/30/08

1.2.1

Quality Assurance Physician

3/30/07

1.2.2

CRC Manager

12/1/07

1.2.3

CRC Secretary

12/1/07

1.2.4

CRC Receptionist

12/1/07

1.2.5

CRC Equipment Technician

3/30/07

1.2.6

Infection Control Practitioner

3/30/07

1.2.7

CRC Pharmacist

3/30/07

1.2.8

Clinical Protocol Coordinator (CPC)

3/30/07

1.3

Creating and Revising CRC Policies

3/30/07

1.4

CRC Facility and Satellite Facilities – Defined

3/30/07

Attachments

Attachments A, B, C, D, E, F

3/30/07

2.0

HUMAN SUBJECT RESEARCH APPLICATION PROCESS

2.1

Policy Regarding Clinical Research

4/13/07

2.2

Clinical Research - Defined

4/13/07

2.3

Initiating an IRB-Approved CIRC/Protocol at the CRC

4/13/07

2.4

Protocol Adherence

1/3/06

3.0

CLINICAL RESEARCH CENTER PROFESSIONAL STAFF

3.1

Application/Appointment Process – Membership in the CRC Clinical Staff

4/13/07

3.2

CRC Clinical Staff Training and Education

4/13/07

3.3

Requests to be Excused from an Aspect of Patient Care by CRC Staff

4/13/07

Approved By

Medical Dept Chairperson

4.0

RESPONSIBLE PHYSICIAN – DUTIES AND RESPONSIBILITIES

4.1

Responsible Physician – Duties and Responsibilities

1/10/06

4.2

Maintenance of Clinical Program Logbooks

5/18/07

4.3

Adverse Event Reporting

5/18/07

4.3 Attachment

Adverse Events Report Form

12/1/07

5.0

MEDICAL RECORDS

5.1

Maintenance of Subject Records

12/1/07

5.2

Review of Subject Records

5/18/07

5.3

Release of a CRC Medical Records

5/18/07

5.4

Confidentiality

5/18/07

5.5

Subject Chart Requirements

5/18/07

5.6

Maintenance and use of CRC Forms

5/18/07

5.7

Subject Records: Storage and Access

5/18/07

6.0

ENVIRONMENT OF CARE

6.1

Scheduling and Check-In Procedures for CRC Research Subjects

10/11/04

6.2

CRC Safety

12/1/07

6.3

CRC Security

12/1/07

6.4

CRC Medical & Other Hazardous Materials Control Plan

10/11/04

6.5

CRC Emergency Preparedness Plan

12/1/07

6.6

CRC Life Safety Management Plan

10/11/04

6.7

CRC Utility System Management Plan

10/11/04

6.8

Preventative Maintenance Program

12/1/07

6.9

Crash Carts

12/1/07

6.10

Advance Directives

10/11/04

1/10/06

7.0

Infection Control Procedure

(Infection Control Manual)

10/11/04

8.0

PHARMACY AND CONTROL OF PHARMACEUTICALS

8.1

Central Pharmacy Access

10/11/04

8.2

Procurement, Dispensing and Disposal of Pharmaceuticals

10/11/04

8.3

CRC Pharmacy Satellite Facilities: Secured Storage

10/11/04

FORMS

See Pharmacist or SBMS Subject Areas for relevant forms