Orientation
Initiate
to start with
Make appointments
Prepare documents
Submit
Create dossier
Get approval
Start
Sign contract
Prepare and start
Submit an amendment
Reasons for an amendment
Add to dossier
Get approval
Orientation

Step-by-step How to initiate a sub-biobank
Do you want to start a new collection? Would you like to professionalize your current collection? You will find here a step-by-step guide to setting up a sub biobank including links to necessary documents.Initiation of a new sub-biobank
Read about what you should take into consideration when starting a new sub-biobank. read moreInitiate
Make appointments
Appointments
Make appointments with the- Biobank manager to go through the check list
- Biobank IT coordinator if necessary to discuss plans for data capture
- Laboratory manager if necessary to discuss logistics regarding sample collection
Data capture
Read the guidelines regarding data capture for a sub-biobank (in Dutch). read morePrepare documents
Prepare documents for the CMO Radboudumc review
Fill in the following documents
Fill in the deelbiobank document and include the attachments (see Procedure Informed Consent).Submit
Create dossier
Fill-in contact details and name of dossier
N.B. You can leave the NL-number en protocol number empty. Within a few minutes you will receive an email with the dossier number and dossier code.Policy regarding unsolicited findings
The incidence of unsolicited findings has increased with the arrival of new techniques for studying biomaterial. read morePolicy regarding unsolicited findings
The incidence of unsolicited findings has increased with the arrival of new techniques for studying biomaterial. In close collaboration with the department of Human Genetics and the CMO-light, building blocks [LS1] have been developed to assist with documenting patient information and informed consent regarding unsolicited findings. There is also a template form developed for the withdrawal of previously given consent. For more information please contact the Commissie Mensgebonden Onderzoek (cmo@iwkv.umcn.nl).Upload documents to the dossier
Use dossier number and dossier code in email to log in. Upload deelbiobank document, including attachments with your letter of application.Get approval
Await the CMO Radboudumc review
Send a copy of the approval to RadboudBiobank@radboudumc.nl
Start
Sign contract
Sign contract with the Radboud Biobank
Contact Lovice Sutherland to make an appointment.Prepare and start
Prepare to include patients
Let the Radboud Biobank know a minimum of 2 weeks in advance when you plan to start collecting samples.Steps to take before including patients
Please read and carry out the steps listed in the document "Medical - ethical approval - what next?" read moreDescribe the process
Use the template (Dutch) to help document the information and processes regarding the initiation of the sub-biobank for all employees involved. read moreSubmit an amendment
Reasons for an amendment
Reasons for an amendment
- Adjustments to the patient information and/or the informed consent
- Adjustments in the sort of biomaterial collected
- Adjustments to the patient inclusion/exclusion criteria
Add to dossier
Open original CMO Radboudumc dossier
Fill in the dossier (make use of the dossier number and code on the original application).
visit websiteGet approval
Get approval
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Inform the Radboud Biobank of the planned changes.
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Await the CMO Radboudumc review. Send a copy of the approval to Radboud Biobank.
send a copy