Study title and brief working title:

Principal Investigator:

E-mail/phone number:

Project Manager or other study contact:

E-mail/phone number:

Sites (DZNE sites and external Institutions)

Primary Coordination Site/Institution:

Other Sites/Institutions in multicenter studies:

Sites/Institutions for other study activities (e.g. subject recruitment, subject evaluations, data analysis):

Please indicate function and contact person.

Are collaboration agreements for external partners needed?	☐ no	☐ yes

If yes, are collaboration agreements already in place?	☐ no	☐ yes

The study is	☐ a new DZNE study.

☐ a modification of an existing DZNE study.

Original study title/number:

Funding source(s) for the study:

Include all sources, e.g. DZNE, university, industry, other third party funds.

Study participants receive compensation from DZNE funds for participation:	☐ no	☐ yes

Please specify:

☐ settlement of subjects’ compensation (up to 10 €/h): approx. € per subject

☐ lump-sum compensation (up to 200 €/day): € per subject

Study participants receive compensation from DZNE funds for expenses (travel, etc.): ☐ no	☐ yes

Please specify:

☐ according to individual expense receipts (if possible only in exceptional cases)

☐ flat rate amount(s):

Cost center/project number:

Estimated start date of study:
Estimated completion date of study:

Estimated number of subjects:

Data Collection and Evaluation Tools to be utilized in this study

New analysis of previously collected data:	☐ no	☐ yes

Patient medical record review:	☐ no	☐ yes

Questionnaires/Tests (specify):

Are licenses required?	☐ no	☐ yes

If yes, are licenses already at hand?	☐ no	☐ yes

It is the responsibility of the investigator to ensure that licenses are at hand prior to the start of the study.

Please contact klinische-lizenzen@dzne.de in case you have any questions.

Imaging (specify imaging modalities and contrast materials/ligands):

☐ 3T MRI, ☐ 7T MRI, ☐ PET, ☐ SPECT

If a tracer is used, is it already licensed?	☐ no	☐ yes

Collection of biological specimens:

☐ Blood: ☐ DNA, ☐ RNA, ☐ Serum, ☐ Plasma;

☐ CSF; ☐ Urine; ☐ Hair; ☐ Skin; ☐ other:

Other:

The following regulations are pertinent to the study

Please contact the Legal Office (jutta.hoppenau@dzne.de) in case you have any questions.

Arzneimittelgesetz:	☐ no	☐ yes

Medizinproduktegesetz:	☐ no	☐ yes

Strahlenschutzgesetz:	☐ no	☐ yes

Röntgenverordnung:	☐ no	☐ yes

BfS approval required?	☐ no	☐ yes

Date of submission:

Shall the study be listed on the Websites of the DZNE?	☐ no	☐ yes

Please send the completed form to klinische-studien@dzne.de together with any available draft study documents (Ethics Committee application, protocol, information for study participants, informed consent).

After submission of this form a study number will be assigned and distributed to the investigator and DZNE administrative offices. The Clinical Research Platform staff will contact the study investigator to assist with administrative preparations. It is the responsibility of the investigator to ensure that the necessary preparations are completed prior to the start of the study (no project management by CRP).

Please remember to prepare a procedural report (Verfahrensmeldung) and send it to datenschutz@dzne.de as any public or private organisation is obliged to keep a procedure log.

Reviewed by (printed name)	Study number	Date and Signature