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Office Contact Info.
Phone: (631) 344-3604
Fax: (631) 344-2358
Mail address: Bldg. 490

BNL CLINICAL RESEARCH CENTER

POLICIES AND PROCEDURES MANUAL


TABLE OF CONTENTS

      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 2/1/06
  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  A, B, C, D, E, F 3/30/07
2.0   HUMAN SUBJECT RESEARCH APPLICATION PROCESS  
  2.1 Policy Regarding Clinical Research 5/1/09
  2.2 Clinical Research - Defined 5/1/09
  2.3 Initiating an IRB-Approved Protocol 5/1/09
  2.4 Protocol Adherence 5/1/09
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
4.0   RESPONSIBLE PHYSICIAN – DUTIES AND RESPONSIBILITIES  
  4.1 Responsible Physician – Duties and Responsibilities 5/1/09
  4.2 Maintenance of Clinical Program Logbooks 5/1/09
  4.3 Adverse Event Reporting 4/1/09
   Attachment Adverse Events Report Form 4/1/09
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 4/14/09
  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 5/1/09
  6.2 CRC Safety 5/1/09
  6.3 CRC Security 5/1/09
  6.4 CRC Medical & Other Hazardous Materials Control Plan 5/1/09
  6.5 CRC Emergency Preparedness Plan 5/1/09
  6.6 CRC Life Safety Management Plan 5/1/09
  6.7 CRC Utility System Management Plan 5/1/09
  6.8 Preventative Maintenance Program 5/1/09
  6.9 Crash Carts 5/1/09
  6.11 Emergency Medical Care Provisions 5/1/09
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  

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Last Modified: April 22, 2009
Please forward all questions about this site to: Denise Monteleone
 


DOE, Office of ScienceOne of ten national laboratories overseen and primarily funded by the Office of Science of the U.S. Department of Energy (DOE), Brookhaven National Laboratory conducts research in the physical, biomedical, and environmental sciences, as well as in energy technologies and national security. Brookhaven Lab also builds and operates major scientific facilities available to university, industry and government researchers. Brookhaven is operated and managed for DOE's Office of Science by Brookhaven Science Associates, a limited-liability company founded by Stony Brook University, the largest academic user of Laboratory facilities, and Battelle, a nonprofit, applied science and technology organization.

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