What is it? Why is it important?
The implementation of workflow activities involves many different:
- Players, such as:
- Activities, such as obtaining consent from donors, and the collection, transport, processing, storage, distribution and sometimes analysis of BM
- Facilities and materials (e.g. management of biobanking freezers, storage premises, consumables)
In order to support the credibility of analytical results obtained from BM, requires that sample workflow activities are documented and traceable. Forms and logs are essential tools used to fulfill these requirements (e.g. logs and forms are provided in electronic and paper form).
What do I need to do?
Based on the planned collection of BM:
- Define expected workflow activities and create applicable forms and logs. Aspects to consider include to:
- Define how to document the required data, either electronically directly in BIMS or (initially) on paper forms.
- Define the user of the document (e.g. physician, study nurse)
- Request only information relevant to a given activity and avoid “nice to have” that overload forms and reduces compliance
- Keep required instructions to a minimum and to the point (e.g. refer to applicable SOPs/WIs or user manuals)
- Create forms and logs that are clear and easy to understand, and have them reviewed and validated by staff entering the data
- Integrate forms and logs in a document management system. This ensures forms and logs are reviewed on a regular basis, while keeping validated versions in circulation
- Train staff on how to implement logs and forms
Examples of biobanking forms:
- Sample collection forms: include collection date and time, and the identity of the person responsible for the collection (e.g. name and signature). In addition the form contains instructions on collection vesicle and amount, labelling procedures, and storage requirements (e.g. on ice, in fridge or freezer, protected from light). Additional information might include donor fasting state, gender, age
- Sample reception forms: includes reception date and time, and the identity of the person responsible for the reception (e.g. name and signature). In addition the form contains instructions on potential handling and storage requirements prior to sample processing.
- Sample processing forms: includes processing date and time, and the identity of the person(s) responsible for sample processing (e.g. name(s) and signature(s)). In addition the form contains instructions on key processing steps (e.g. centrifugation speed and time, aliquoting procedures, sample quality tests, required storage conditions)
- Sample storage forms: includes storage date and time, and the identity of the person responsible for sample storage (e.g. name and signature). In addition th form contains information regarding storage temperature, and sample location in storage premises (e.g. freezer)
Example of biobanking logs:
- Donor identification log: links donor identity with biobanking BM code. Donor identity must not be accessible in BIMS but protected at all times. The log is only accessible to authorized personnel
- Shipment log: documents information on distributed biobank samples
- Equipment usage log: documents the date and time and the person using the equipment
- Expiring consumable log: documents consumables and their expiry date. The log is checked on an ongoing basis in order to ensure expired products are not used.
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
- Sample tracking Form
- Participant ID Log
- Shipping Log
- Expiring consumables log