- Development and introduction of Standard Operating Procedures and Working Instructions
- Staff training and contents of Personal File
- Noncompliance with Quality Standards
- SOP Deviation
- External and internal audit
- Receipt, storage and use of documents of clinical studies
- Maintenance of investigator’s file
- Source documentation
- Biosample handling
- Investigational drug handling
- Equipment service
- Selection and interaction with suppliers of goods and services
- Informed Consent Process
- Confidentiality
- Study subject enrollment
- Archiving of Study documents
- Safety reporting
- Date entry into Case Report Form (CRF)
- Study monitoring
- Interaction with the Ethics Committee and Regulatory Authorities
- Resuscitation procedures
- Working instruction for thecatering organization of subjects
- Working instruction for calling a resuscitator
- Working instruction for recording temperature, leakage and voltage
The sites of the network work under the same Quality Management System.