Perinatal Biobank of Research Centre for Natural Sciences in Budapest
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