6. Biological Specimen

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment.

We have not been able to determine an answer to this question. Much depends on whether the biological specimens are being moved within the EU (not within the EEA) or from/to outside the EU, in which (latter) case the requirements are likely to be more stringent.

6.2 Does local regulation require any separate consent for biological specimen collection, storage, and future research? If yes, please explain if there are any templates and/or links to be followed.

No, it does not need a separate consent (unless it is for a sub-study). Information on biological collection can be included within the main participant information sheet. 

The ICF template published by the Medical Research Agency, provides options of the required information/language to be included for those cases when biological specimen collection will take place during a study.

6.3 Does the local authority require any specific documents for customs clearance?

Yes, it will depend on where the samples will be shipped to.

The European Commission has some information on customs clearance documents and procedures that may be useful.