Your Easy Guide to Clinical Studies

An important expected requirement for any study or research project is the ability to:

• Provide confidence in its research results
• Contribute to the advancement in health care

 

Information retrieved from Biological Material (BM) provide answer(s) to scientific questions. The source of retrieved and examined BM originate from:

• Clinical studies, such as therapeutic or drug studies including health-related interventional studies (e.g. primary-, secondary endpoints)
• Non-clinical studies (e.g. research question(s)

 

In order to provide confidence in data retrieved from BM requires that its “life cycle” from collection to analysis remains traceable.

Irrespective of the source of acquired BM, donors of BM must agree to have their biological specimens and data used for research.

Ensure the “life cycle” of your BM remains traceable. This requires the introduction of standardized biobanking processes followed by its ongoing documentation.

A correct and traceable documentation of the sample workflow is especially important. Aspects to consider include the:

• Collection of BM (e.g. method, timing)
• Transport and reception of BM (e.g. means, temperature, timing)
• Processing of BM (e.g. centrifugation, aliquoting, sequencing)
• Storage of BM (e.g. freezing including temperature control, and storage duration)
• Distribution and shipment of BM (e.g. timing, temperature)
• Analysis of BM

 

Processing and storage differ significantly between liquid and tissue specimens. Make yourself familiar with optimal processing methods.

 

Implement ongoing quality controls to ensure defined processes remain:

• Valid and are correctly followed
• Documentation is complete and quality relevant
• Study staff remains trained

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

SBP Documents

SOPs, Forms and Templates – see in particular

• Improvement Management SOP

References

Declaration of Taipei – see in particular principle

• 1 Ethical principles in medical research

Swiss Law

ClinO – see in particular section

• Section 6 Storage of HrPD and BM in clinical studies

HRO – see in particular articles

• Art. 5 Storage of HRpD and BM in research projects
• Art. 24 General provision for further use