• Home (Dutch)
  • Contact
  •  EN 
  • Employee login

Documents in Docportal (UMCG only)

Print 

​​​​​​​​​​​​​​​​​​​​​​​​In the tables below you find the (templates of) documents required for your application for ethical review and the required names for these documents. Please explain in the cover letter in case you will not submit a required document for ethical review.

Please always attach documents in PDF.

Note that:​

  • For some documents that are required, no templates are available yet.​​
  • ​​​​It is not obliged to use the templates, for example when required documents are available from the sponsor. If you decide not to use a template, make sure all information needed for ethical review is included in the document you submit.
  • After submission, you should receive an acknowledgement of receipt. If you do not receive this within 1 hour, please contact the nWMO loket: (06) 256 503 99, Contact

​For more information on:

  • nWMO Kaderreglement, click here  (NOT required for your application)​.
  • Submission Manual for researchers, click here
  • ​CTc/LTc: Meeting schedule, members of the committee, and contact details:​ ​click here​​

​Not in scope​​

Please do not submit studies outside the scope of the UMCG non-WMO System (check nWMO Kaderreglement), including:​

  • ​Amendments for studies not previously approved by the CTc or an LTc​


Start submission



Study without informed consent (none of the participants will be asked IC)

Study without informed consent (none of the participants will be asked IC)  
    Required name doc (track changes off) Required name doc for revision (track changes on)
Cover letter REQUIRED A1 Aanbiedingsbrief (vul in Research Register nummer) Not applicable
Study protocol REQUIRED C1 Onderzoeksprotocol (RR nummer) C1 Onderzoeksprotocol TC (RR nummer)
Data management plan REQUIRED (or include DMP in study protocol) C1 Data management Plan (RR nummer) C1 Data management Plan TC (RR nummer)
MDTA and/or Data processing Agreement

contact: mail
You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval. Not applicable Not applicable
decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review P1 Besluit door andere commissie (RR nummer) Not applicable

 

Study with informed consent (one or more participants will be asked IC)

Participants include: adults (≥16yrs)  

 

    Required name doc (track changes off) Required name doc for revision (track changes on)
Cover letter REQUIRED A1 Aanbiedingsbrief (vul in Research Register nummer) Not applicable
Study protocol REQUIRED C1 Onderzoeksprotocol (RR nummer) C1 Onderzoeksprotocol TC (RR nummer)
Data management plan REQUIRED (or include DMP in study protocol) C1 Data management Plan (RR nummer) C1 Data management Plan TC (RR nummer)
Information letter for participant REQUIRED E1 Informatiebrief deelnemers ouder dan 16 jaar (RR nummer) E1 Informatiebrief deelnemers ouder dan 16 jaar TC (RR nummer)
MDTA and/or Data processing Agreement

contact: mail
 
You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval.

Not applicable

Not applicable
decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review P1 Besluit door andere commissie (RR nummer) Not applicable

 

Participants include: children (12-16yrs)  

 

    Required name doc (track changes off) Required name doc for revision (track changes on)
Cover letter REQUIRED A1 Aanbiedingsbrief (vul in Research Register nummer) Not applicable
Study protocol  REQUIRED C1 Onderzoeksprotocol (RR nummer) C1 Onderzoeks-protocol TC (RR nummer)
Data management plan REQUIRED (or include DMP in study protocol) C1 Data management Plan (RR nummer) C1 Data management Plan TC (RR nummer)
Information letter for child (study) REQUIRED E1 Informatiebrief deelnemers ouder dan 16 jaar (RR nummer)   E1 Informatiebrief voor kinderen 12 – 16 jaar TC (RR nummer)
Informed consent form for child(study) REQUIRED  E2 Toestemmings-formulier voor kinderen 12 – 16 jaar (RR nummer)  E2 Toestemmings-formulier voor kinderen 12 – 16 jaar TC (RR nummer)
Information letter for parents / guardians REQUIRED  E1 Informatiebrief voor ouders of voogd(en) (RR nummer)  E1 Informatiebrief voor ouders of voogd(en) TC (RR nummer)
MDTA and/or Data processing Agreement

contact: mail
 
You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval.

Not applicable

Not applicable
decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review P1 Besluit door andere commissie (RR nummer) Not applicable

 

 

Participants include: children (<12 yrs)   
    Required name doc (track changes off) Required name doc for revision (track changes on)
Cover letter REQUIRED A1 Aanbiedingsbrief (vul in Research Register nummer) Not applicable
Study protocol REQUIRED C1 Onderzoeksprotocol (RR nummer) C1 Onderzoeks-protocol TC (RR nummer)
Data management plan REQUIRED (or include DMP in study protocol) C1 Data management Plan (RR nummer) C1 Data management Plan TC (RR nummer)
Information letter for legal representative REQUIRED E1 Informatiebrief voor wettelijke vertegenwoordiger (RR nummer) E1 Informatiebrief voor wettelijke vertegenwoordiger TC (RR nummer)
Informed consent form for legal representative REQUIRED E2 Toestemmings-formulier voor wettelijke vertegenwoordiger (RR nummer) E2 Toestemmings-formulier voor wettelijke vertegenwoordiger TC (RR nummer)
MDTA and/or Data processing Agreement

contact: mail
You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval. Not applicable Not applicable
decision letter other ethical/
scientific committee
REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review P1 Besluit door andere commissie (RR nummer) Not applicable
       

 

 

Participants include: otherwise incompetent persons (eg Alzheimer disease)  
    Required name doc (track changes off) Required name doc for revision (track changes on)
Cover letter REQUIRED A1 Aanbiedingsbrief (vul in Research Register nummer) Not applicable
Study protocol REQUIRED C1 Onderzoeksprotocol (RR nummer) C1 Onderzoeks-protocol TC (RR nummer)
Data management plan REQUIRED (or include DMP in study protocol) C1 Data management Plan (RR nummer) C1 Data management Plan TC (RR nummer)
Information letter for legal representative REQUIRED E1 Informatiebrief voor wettelijke vertegenwoordiger (RR nummer) E1 Informatiebrief voor wettelijke vertegenwoordiger TC (RR nummer)
Informed consent form for legal representative REQUIRED E2 Toestemmings-formulier voor wettelijke vertegenwoordiger (RR nummer) E2 Toestemmings-formulier voor wettelijke vertegenwoordiger TC (RR nummer)
MDTA and/or Data processing Agreement

contact: mail
You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval.

Not applicable

Not applicable
decision letter other ethical/
scientific committee
REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review P1 Besluit door andere commissie (RR nummer) Not applicable
       

Start De novo Bio-/Databank (incl secondary use with Informed consent)

Participants include: adults (≥16yrs)  
    Required name doc (track changes off) Required name doc for revision (track changes on)
Cover letter REQUIRED A1 Aanbiedingsbrief (Research Register nummer) Not applicable
Data/Biobank guideline 'De novo' REQUIRED K5 Data- of Biobankguideline De Novo (RR nummer) K5 Data- of Biobankguideline De Novo TC (RR nummer)
Data/
Biobankprotocol
'De novo'
REQUIRED C1 Data- of Biobankprotocol De Novo (RR nummer) C1 Data- of Biobankprotocol De Novo TC (RR nummer)
Information letter for participant (bio-/databank) REQUIRED E1 Informatiebrief deelnemers ouder dan 16 jaar (RR nummer) E1 Informatiebrief deelnemers ouder dan 16 jaar TC (RR nummer)
Informed consent form for participant (bio-/databank) REQUIRED E2 Toestemmings-formulier voor deelnemers ouder dan 16 jaar (RR nummer) E2 Toestemmings-formulier voor deelnemers ouder dan 16 jaar TC (RR nummer)
Withdrawal form for participant (bio-/databank) REQUIRED E2 Terugtrekkings-formulier voor deelnemers (RR nummer) E2 Terugtrekkings-formulier voor deelnemers TC (RR nummer)
MDTA and/or Data processing Agreement

contact: mail
You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval. Not applicable Not applicable
decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review P1 Besluit door andere commissie (RR nummer) Not applicable

 

 

 

Participants include: children (12-16yrs)  
    Required name doc (track changes off) Required name doc for revision (track changes on)
Cover letter REQUIRED A1 Aanbiedingsbrief (Research Register nummer) Not applicable
Data/Biobank guideline 'De novo' REQUIRED K5 Data- of Biobankguideline De Novo (RR nummer) K5 Data- of Biobankguideline De Novo TC (RR nummer)
Data/
Biobankprotocol
'De novo'
REQUIRED C1 Data- of Biobankprotocol De Novo (RR nummer) C1 Data- of Biobankprotocol De Novo TC (RR nummer)
Information letter for child (bio-/databank) REQUIRED E1 Informatiebrief voor kinderen van 12 tot 16 jaar (RR nummer) E1 Informatiebrief voor kinderen van 12 tot 16 jaar TC (RR nummer)
Informed consent form for child (bio-/databank) REQUIRED E2 Toestemmings-formulier voor kinderen van 12 – 16 jaar (RR nummer) E2 Toestemmings-formulier voor kinderen van 12 – 16 jaar TC (RR nummer)
Withdrawal form for child (bio-/databank) REQUIRED E2 Terugtrekkings-formulier voor kinderen 12 – 16 jaar (RR nummer) E2 Terugtrekkings-formulier voor kinderen 12 – 16 jaar TC (RR nummer)
Information letter for parents / guardians REQUIRED E1 Informatiebrief voor ouders of voogd(en) (RR nummer) E1 Informatiebrief voor ouders of voogd(en) TC (RR nummer)
Informed consent form for both parents / guardians REQUIRED E2 Toestemmings-formulier voor beide ouders of voogd(en) (RR nummer) E2 Toestemmings-formulier voor beide ouders of voogd(en) TC (RR nummer)
Withdrawal form for parents / guardians REQUIRED E2 Terugtrekkings-formulier voor ouders of voogd(en) (RR nummer) E2 Terugtrekkings-formulier voor ouders of voogd(en) TC (RR nummer)
MDTA and/or Data processing Agreement

contact: mail
You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval. Not applicable Not applicable
decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review P1 Besluit door andere commissie (RR nummer) Not applicable

 

 

 

Participants include: children (<12 yrs)  

 

    Required name doc (track changes off)

Required name doc for revision (track changes on)
Cover letter REQUIRED A1 Aanbiedingsbrief (Research Register nummer) Not applicable
Data/Biobank guideline 'De novo' REQUIRED K5 Data- of Biobankguideline De Novo (RR nummer) K5 Data- of Biobankguideline De Novo TC (RR nummer)
Data/
Biobankprotocol
'De novo'
REQUIRED C1 Data- of Biobankprotocol De Novo (RR nummer) C1 Data- of Biobankprotocol De Novo TC (RR nummer)
Information letter for parents / guardians REQUIRED E1 Informatiebrief voor ouders of voogd(en) (RR nummer) E1 Informatiebrief voor ouders of voogd(en) TC (RR nummer)
Informed consent form for both parents / guardians REQUIRED E2 Toestemmings-formulier voor beide ouders of voogd(en) (RR nummer) E2 Toestemmings-formulier voor beide ouders of voogd(en) TC (RR nummer)
Withdrawal form for parents / guardians REQUIRED E2 Terugtrekkings-formulier voor ouders of voogd(en) (RR nummer) E2 Terugtrekkings-formulier voor ouders of voogd(en) TC (RR nummer)
MDTA and/or Data processing Agreement

contact: mail
You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval. Not applicable Not applicable
decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review P1 Besluit door andere commissie (RR nummer) Not applicable

 

 

 

Participants include: otherwise incompetent persons (eg Alzheimer disease)  

 

    Required name doc (track changes off) Required name doc for revision (track changes on)
Cover letter REQUIRED A1 Aanbiedingsbrief (Research Register nummer) Not applicable
Data/Biobank guideline 'De novo' REQUIRED K5 Data- of Biobankguideline De Novo (RR nummer) K5 Data- of Biobankguideline De Novo TC (RR nummer)
Data/
Biobankprotocol
'De novo'
REQUIRED C1 Data- of Biobankprotocol De Novo (RR nummer) C1 Data- of Biobankprotocol De Novo TC (RR nummer)
Information letter for legal representative REQUIRED E1 Informatiebrief wettelijk vertegenwoordiger (RR nummer) E1 Informatiebrief wettelijk vertegenwoordiger TC (RR nummer)
Informed consent form for legal representative REQUIRED E2 Toestemmings-formulier wettelijk vertegenwoordiger (RR nummer) E2 Toestemmings-formulier wettelijk vertegenwoordiger TC (RR nummer)
Withdrawal form for legal representative REQUIRED E2 Terugtrekkings-formulier wettelijk vertegenwoordiger (RR nummer) E2 Terugtrekkings-formulier wettelijk vertegenwoordiger TC (RR nummer)
MDTA and/or Data processing Agreement

contact: mail
You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval. Not applicable Not applicable
decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review P1 Besluit door andere commissie (RR nummer) Not applicable

 

 

 

 

Start/management Secondary use Bio-/Databank 'No objection'

Secondary use Bio-/Databank 'No objection'  
    Required name doc (track changes off) Required name doc for revision (track changes on)
Cover letter REQUIRED A1 Aanbiedingsbrief (Research Register nummer) Not applicable
Data/Biobank guideline 'Secondary use' REQUIRED K5 Data- of Biobankguideline Sec use (RR nummer) K5 Data- of Biobankguideline Sec use TC (RR nummer)
Data/Biobankprotocol 'Secondary use' REQUIRED C1 Data- of Biobankprotocol Sec use (RR nummer) C1 Data- of Biobankprotocol Sec use TC (RR nummer)
MDTA and/or Data processing Agreement

contact: mail
You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval. Not applicable Not applicable
decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review P1 Besluit door andere commissie (RR nummer) Not applicable