What is it? Why is it important?

Sample collection is the sample-workflow step where Biological Material (BM) is retrieved from a donor and placed in a primary container (e.g. a blood collection tube).


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.


Ask yourself:

  • 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


Write an SOP and/or a WI that explains the collection process:

  • 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

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

SBP Documents

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

Swiss Law

HRO – see in particular article

  • Art. 21 Serious Events

Publications PubMed

PMID: 28242283

  • Giavarina, et al. “Blood venous sample collection: Recommendations overview and a checklist to improve quality”

PMID: 23072858

  • Lippi et al. "Preanalytical quality improvement: in quality we trust"

PMID: 25979952

  • Ellervik et al. “Preanalytical variables affecting the integrity of human biospecimens in biobanking”

PMID: 29377712

  • Betsou et al. “Standard PREanalytical Code Version 3.0
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • ID – Identity
  • ISO – International Standards Organisation
  • PMID – PubMed ID
  • SOPs (Standard Operating Procedures
  • SBP – Swiss Biobanking Platform
  • WI – Working Instructions
Development ↦ Biobanking ↦ Handling of Biological Material ↦ Sample Collection

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Biobanking ↦ Handling of Biological Material ↦ Sample Collection

Please note: the Easy-GCS tool is currently under construction.