Compliance with Member State applicable rules for the collection, storage and future use of human biological samples (Article 7.1h)

Full title of the clinical trial	EU trial number	
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Responsible entity for the samples (legally): 
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How to use this document 
This form is to be used by Sponsors of clinical trials in the Part II application dossier in the Netherlands to provide information about “compliance with the applicable rules for the collection, storage and future use of biological samples from clinical trial subjects" (Regulation (EU) No 536/2014, Article 7.1 (h)). 

If the information is already provided elsewhere in the Application Dossier, a reference should be provided.

This Part II template has been developed by the EU Clinical Trials Expert Group to comply with Regulation (EU) No 536/2014 Clinical Trials on Medicinal Products for Human Use. 

I -  Description of the biological samples involved in the clinical trial	
Section 1 - Does this clinical trial involve new sampling of the subjects (newly collected samples)?
 Yes, please fill in the requested information in section 1
 No, not applicable. Please continue with section 2

Note: The sponsor needs to fill in at least one of the sections 1 or 2 
	
1.1 What type(s) of samples will be collected from the subject?
State the original material that is collected from the patient e.g. blood, tissue (state type of tissue), urine, saliva etc. Do not include information on the preparation of the sample. 
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1.2	Total number of samples, fragments (e.g. aliquots, tissue blocks, sections) and the total volume (if applicable) per individual subject: 
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1.3	The maximum number of samples and maximum volume (if applicable) on one single occasion:
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1.4	Will the samples be collected as part of routine health care? 
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Section 2 - Does this clinical trial involve the collection of existing archive samples (e.g. archived diagnostic material or other biobank material)?
 Yes, please fill in the requested information in section 2
 No, not applicable. Please continue with section 3

Note:  The sponsor needs to fill in at least one of the sections 1 or 2 	
2.1 What type(s) of archived material/samples will be used?
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2.2 Provide the total number of samples, fragments (e.g. aliquots, tissue blocks, sections) and total volume (if applicable) that the Sponsor needs access to from each individual subject.
Example: 20 sections per biopsy from each individual subject is needed
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2.3	Will new consent be obtained for the use of the archive samples in the clinical trial (if in line with national legislation)? If not, explain.
(if applicable, add the text of the original consent)
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II – Use, storage, and transfer of biological samples	
Section 3 – Use of samples for a purpose within the objective of this clinical trial (i.e. for use described in the protocol)

Note: This section must be filled in for both newly collected and existing archive samples	
3.1 Where will the samples be analysed? 
i.e. within the clinical laboratory, within/outside the Sponsor’s organization, within/outside the Member State where collected or within/outside EU/EEA.
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3.2	If the samples will be sent to another organisation for analyses (as part of the trial), how will they be managed after the analyses have been carried out? 
i.e. destroyed, returned to responsible entity for the samples (legally), stored at the site where analysed, anonymised etc.

Note: An agreement (Material Transfer Agreement or equivalent) that regulates how the sample are to be handled shall be established with the recipient  
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3.3	Where will the samples be stored?
i.e. within/outside the Sponsor’s organisation, within/outside the Member State where collected or within/outside EU/EEA
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3.4	How long will the samples be stored? 
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3.5	What type of connection is available between samples and individual subjects? 
☐	Direct connection (samples marked with e.g. initials, date of birth)
☐	Pseudonymised connection (samples marked with code)
☐	No connection, samples are anonymised (i.e. samples can neither directly nor indirectly, with reasonably means according to recital 26 of the General Data Protection Regulation (EU) 2016/679, be linked to the sample donor)	
3.6	Who will have access to the samples?
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3.7	Who will have access to the sample code list (if applicable)?
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Section 4 - Will newly collected samples or existing archive samples be stored for future use?
For other use than described in the protocol. 
☐ Yes, please fill in the requested information in this section 
☐ No, samples will be destroyed, please continue with section 5	
4.1	 What is the purpose of the future use?
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4.2	How long will the samples be stored?  
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4.3	Where will the samples be stored?  
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4.4	What type of connection is available between samples and individual subject? 
☐	Direct connection (samples marked with e.g. initials, date of birth)
☐	Pseudonymised connection (samples marked with code)
☐	No connection, samples are anonymised (i.e. samples can neither directly nor indirectly, with reasonably means according to recital 26 of the General Data Protection Regulation (EU) 2016/679, be linked to the sample donor) 	
4.5	Who will have access to the samples?
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4.6 Who will have access to the sample code list (if applicable)?
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4.7	Will the donor be recontacted to give new consent to the use of the samples in future research? If not, explain 
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4.8	If secondary future use of the samples will be in question, will an ethics committee or biobank committee be reviewing whether the purpose of the new study is within the scope of the original provided consent?  
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4.9	Who will be able to make use of the samples?
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4.10	How will unsolicited findings be handled?
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III – Additional information	
Section 5 - Additional information that is required by the current Member States national arrangements and regulations. The sponsor should confirm this prior to submission   

Note: This section will only be filled in if applicable	
5.1	Provide any information (not described above) that is of relevance to the Member State applicable rules on collection, storage, transport and future use of the samples, e.g. on specific national arrangements and regulations regarding the use of human biological samples. 
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