Development↦Biobanking↦Documentation↦Forms and Logs
What is it? Why is it important?
Activities carried out during sample workflow are documented on various forms and logs.
The implementation of workflow activities involves many different:
- Players, such as:
- Activities, such as obtaining consent from donors, collect-, transport-, process-, store-, distribute and sometimes analyze 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.
- Create forms that are clear and easy to understand (e.g. perform staff validations)
- Request only required information 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)
- Have forms and logs reviewed and validated by staff responsible to enter 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: with collection date and time, including 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: with reception date and time for preanalytical processing at the lab
- Sample processing forms: with processing date and time, including instructions on key processing steps (e.g. centrifugation speed and time, aliquoting procedures, sample quality tests, required storage conditions)
- Sample storage forms: with long-term storage date and time, temperature, sample precise location
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