Standard Operating Procedure

1.0

Administration

1.1

1.2

1.3

1.4

Obtaining Confidentiality Disclosure Agreements

Handling Participant (Donor) Complaints

Administration of Standard Operating Procedures

Job Descriptions, Roles and Responsibilities

2.0

PARTICIPANT AND RECRUITMENT MANAGEMENT

2.1

2.2

2.3

2.4

2.5

2.6

Participant Recruitment into Perinatal Biobank Program

Developing and Revising Consent Forms

Requesting Additional Survey Information

Obtaining Informed Consent

Withdrawal of Consent

Notification of Significant and Relevant Findings

3.0

RECORDS AND DOCUMENTATION MANAGEMENT

3.1

3.2

3.3

Information Access Control

Database Backup Systems

Document Maintenance

4.0

FACILITIES MANAGEMENT / OPERATION

4.1

4.2

4.3

Physical Security at Perinatal Biobank Facilities

Emergency Procedure for Freezer and Refrigerator Failure

Maintenance of Sample Storage Facility and Equipment

5.0

QUALITY ASSURANCE PROCEDURES

5.1

5.2

Assessing Quality of Tissue Specimens

Assessing Quality of Nucleic Acids

6.0

SAFETY

6.1

6.2

Handling Hazardous Chemical Waste

Immunization and Personnel Accident Reporting

7.0

TRAINING

7.1

Education and Training

8.0

MATERIALS HANDLING AND DOCUMENTATION

8.1

8.2

8.3

8.4

8.5

Labeling and Tracking Materials

Biohazardous Waste Management

Inventory Verification

Blood Processing and Storage

Sample Retrieval

9.0

MATERIAL RELEASE

9.1

9.2

Sample Shipping and Transportation

Material Request and Release