Policy 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).
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 collection

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 collection including links to necessary documents.


Initiation of a new collection

Read about what you should take into consideration when starting a new collection.

read more

SOPs

Read about the Radboud Biobank standard requirements for the collection, preparation and storage of biomaterials. read more

Initiate

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 collection (in Dutch).

read more

Questions? Contact us

Lovice Sutherland

+31 (0)24 366 89 77
contact form

Prepare 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 more

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.

Questions? Contact us

Lovice Sutherland

+31 (0)24 366 89 77
contact form

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 more

Describe the process

Use the template (Dutch) to help document the information and processes regarding the initiation of the collection for all employees involved.

read more

Questions? Contact us

Lovice Sutherland

+31 (0)24 366 89 77
contact form

Submit 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 website

Get approval


Get approval

  • Inform the Radboud Biobank of the planned changes.