Compliance with national regulations regarding human biological material
- Description of the plan for the collection, storage and use of biological material. It is recommended to use the European Commission’s template Compliance with Member State applicable rules for the collection, storage and future use of human biological samples (hereinafter referred to as Compliance with use of Biological samples). The collection of samples must be linked to the trial’s endpoints.
- If samples are stored in Norway for more than two months after sampling, the material must be stored in a study-specific biobank linked to the study. It is expected that such biobanks will cease as soon as all analyses have been carried out and by the end of the specified research active period.
- In the document Compliance with use of Biological samples it must be clearly stated what kind of biological material is to be collected, how it is to be analysed, as well as where and for how long it is to be stored. The objective of collecting biological material must be to answer the trial’s endpoints defined in the protocol. It is therefore expected that collected samples will not be stored beyond the active research period. It must be stated whether material is to be stored in a study-specific research biobank linked to the study, possibly the name of the biobank, where it is located and who is responsible for the biobank.
- If samples are to be sent out of the country for analysis in connection with the clinical trial or stored in a foreign biobank, it must be stated to which country, how long the samples are to be stored there and a plan for destruction and/or return of the material.
- If samples are brought into Norway as part of the clinical trial, it must be stated from which country and the plan for possible left-over samples after the analysis.
