What is it? Why is it important?
The collection of Biological Material (BM) might involve potential health risks to donors (e.g. infection, hematoma, bleeding and headache after a spinal tap).
In the event that the establishment of a Biobank is an integral part of a research project (HRO project) or clinical study (ClinO, ClinO-MD, Other studies), the project leader, Site-INV, or SP-INV are responsible to implement measures to ensure donor safety.
Safety events where it cannot be excluded that the event is attributable to the sampling of BM, requires the implementation of safety reporting procedures, such as the reporting of:
What do I need to do?
Define potential risks to donors as a result of the collection of BM. Document risks and define risk control-measures to reduce risks.
Risk control-measures can include to:
- Exclude certain risk groups (e.g. donors with low haemoglobin, haemophilia, pregnancy)
- Limit the collection volume (e.g. blood volume, number of biopsies)
- Equip facilities for the safe collection of BM (e.g. sterile environment, professional staff)
- Limit blood draws to 2 attempts (e.g. avoid to prick the donor more than 2 times)
- Train staff on collection safely measures (e.g. disinfect injection site, ware protection gloves)
- Monitor donor status after the collection of BM (e.g. normal blood pressure)
- Monitor donor and train staff on the handling of post collection adverse events (e.g. drowsiness, pain, bruises)
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
The Swiss Biobanking Platform (SBP) can provide you with support on this topic.
SOPs, Forms and Templates – see in particular
- Safety and complaint SOP
Swissmedic – see in particular
- Human medicine: Safety measures in clinical trials
Declaration of Taipei – see particular principles
- 19 Protection of donors
ICH GCP E6(R2) – see in particular guidelines
- 4.11 Safety reporting
ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking – see in particular section
- 4 General requirements
HRA – see in particular article
- Art. 15 Safety and protective measures
ClinO – see in particular articles
- Art. 37 Notification of safety and protective measures
- Art. 39 Documentation of AE
- Art. 40 Documentation and reporting of SAE
- Art. 42 Documentation and reporting of SAE for in vitro MD
- Art. 63 Documentation and notification of SAE
ClinO-MD – see in particular articles
- Art. 32 Documentation of AE
- Art. 33 Reporting of SAE
- Art. 34 reporting of safety and protective measures
HRO – see in particular article
- Art. 21 Serious event definition and reporting