What is it? Why is it important?
The aim is to ensure that:
- Donors have agreed to the collection of their BM. (e.g. he/she has dated and signed an ICF)
- Donor safety is guaranteed
- Donor identity is protected by using codes for sample labelling (e.g. data confidentiality)
- BM collection is performed in a standardized manner, such as collection:
- Source (e.g. venous blood, biopsy during surgery)
- Means (e.g. container type, collection chemicals needed, BM intermediate storage prior to transport e.g. on ice, at -20°C)
- Timing (e.g. date and time, donor fasting state, maximum acceptable time-laps between collection and BM processing)
- Tracking (e.g. samples are individually labelled for subsequent identification trough a donor identification-log)
By performing and documenting the collection of BM in a standardised manner, allow researchers to:
- Retrace all BM collection procedures, thereby confirming BM integrity. This is especially helpful in the event of unexpected results or quality controls
- Have increased confidence in research results
Collected samples must be clearly identifiable, such as:
- Time and date of BM collection
- Study or project ID (e.g. hospital, department)
- Coded so as to allow for subsequent donor identification
- In the event of multiple or sequential BM collections (e.g. over several weeks or months), the ability to identify or position the BM according to collection sequence and timing
What do I need to do?
Define standardized BM collection and documentation procedures.
- What type of BM do I plan to collect? (e.g. tissue, blood, urine, stools)
- How will BM be obtained? (e.g. through biopsy, surgery, blood draw)
- Will there be single or multiple collections from each donor? (e.g. at specific intervals for a defined period)
- What is the collection site? (e.g. an operating room, hospital services, patient home)
- Who collects the BM? (e.g. a surgeon, nurse, donor)
- For the planned workflow and the downstream analysis:
- How much BM do I need? (volume, scope)
- What primary and subsequent storage containers are required?
- How many collection containers and labels are required in total?
- What additional data do I need? (e.g. donor information)
- What coding system guarantees unambiguous BM tracing among all specimens? To avoid doublets each donor specimen is labelled with a unique identifier
- Include a responsibility list that defines who is responsible for what task
Create relevant registration forms that document collection-related information, such as:
- Timing of BM collection
- Person responsible for BM collection
- Preliminary on site storage conditions (e.g. BM is stored on ice, at room temperature, at -20°C)
- Required information regarding donor status (e.g. demographics, diagnosis and treatment, fasting state, time since last urination, time since last meal, menstruation)
- Staff responsible for the collection of BM are trained and qualified to do so
- Non-conformities that occur during BM collection are documented (e.g. insufficient volume, donor was not fasting, on site storage conditions were sub-optimal, tissue sample was dropped on the floor)
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
- Biological Material SOP
ISO 20387:2018 Biotechnology - Biobanking (access liable to cost)- General Requirements for Biobanking – see in particular section
- 7.2 Collection of biological material and associated data
HRO – see in particular article
- Art. 21 Serious Events
- Giavarina, et al. “Blood venous sample collection: Recommendations overview and a checklist to improve quality”
- Lippi et al. "Preanalytical quality improvement: in quality we trust"
- Ellervik et al. “Preanalytical variables affecting the integrity of human biospecimens in biobanking”
- Betsou et al. “Standard PREanalytical Code Version 3.0