Start a collection

Before you start with the practical organization of a new collection, its characteristics should be well defined. This entails the following: 

1. The scientific goal needs to be clear 
2. Definition of the intended patient categories (in- and exclusion criteria) 
3. Definition of the information model 
4. Definition of the biomaterials/images to be collected: 

• Type of biomaterial/image 
• Frequency of collection 
• Pre-analytic specifications  

If you aim to set up a multicenter collection, please involve the Regional Biobank coordinators of all participating centers to determine the characteristics specified above. In addition, the coordinating UMC must be appointed.  

Please contact your regional Biobank coordinator(s) or the BBMRI.nl team if you want more information. 

The information model 

The information model and data collection system are determined by the initiator(s) of a new collection in collaboration with the regional IT/Data platform coordinator in your UMC. 

In case of a multicenter initiative, the regional IT/Data platform coordinator of the coordinating UMC informs the data/ICT coordinators of the other participating UMCs about the information model and the chosen data collection system. 

Biomaterial 

You should contact your regional Biobank coordinator to determine the biomaterials to be collected and to discuss logistics regarding sample collection. 

In case of a multicenter initiative, the regional Biobank coordinator of the coordinating UMC informs the regional coordinators of the other participating UMCs about the biomaterials to be collected. Note: The logistics regarding sample collection must be discussed in each participating center, because every UMC has its own logistic flow. 

Images 

If applicable, you should contact the data/ICT coordinator in your UMC or the regional IT/Data platform coordinator of BBMRI.nl of the coordinating UMC to discuss the options for storing images. 

 Finances 

Each UMC has its own financial structure with regard to the collection of biomaterial and associated data. That's why the finances have to be discussed in each participating center. Please contact your regional Biobank coordinator if you want more information. 

Protocol 

In this document the specific objectives and ambition of the collection are described, but also from whom and what is collected in the collection.  

There is currently no national template available, however, this is being worked on. As soon as a national template is available, it will be available on this website. Please contact your regional Biobank coordinator to find out if a local template is available. 

The protocol may not exist separately from the participant information and informed consent (PIF). 

Participant information and informed consent (PIF) 

Informed consent is required to participate in a collection. This is a process in which oral information, exchange of views, and asking questions are very important. The written information is also part of this. The purpose of the process and the written information is to inform potential participants in such a way that they can make a well-considered choice whether or not to participate. 

There is currently no national template available, however, this is being worked on. As soon as a national template is available, it will be available on this website. Please contact your regional Biobank coordinator to find out if a local template is available. 

Regulations 

In case of a multicenter initiative, regulations must be drawn up in which the agreements between the participating centers are recorded. Please contact the regional Biobank coordinator of the coordinating UMC or the BBMRI.nl team to find out if examples of regulations are available. You can also check or contact the ELSI service desk for examples of templates. 

You should submit the protocol, Participant information and informed consent to Institutional Review Board (IRB) of your UMC or the IRB of the coordinating UMC. 

Note: There is not yet a national guideline as to which documents must be submitted to the IRB. There may be differences between the UMCs. Therefore, please contact the IRB before submitting or contact your regional Biobank coordinator of the coordinating UMC. 

In case of a multicenter initiative, after approval of the documents by the IRB of the coordinating UMC, the local assessment can be initiated in the other participating UMCs.  

Start 

Once the IRB grants approval to start a collection you can proceed with the preparatory work for collecting biomaterial and associated data and, if applicable, images.