Contact data of the applicant(s)1:	[Researcher's first and last name] [Contact data of the researcher]
If applicable, contact data of the group leader1	[Researcher's first and last name] [Contact data of the researcher]
Research institution:	[Name of the research institution] [Address of the research institution]
Request form abbreviation: (to be issued by QS)

1All applicants must sign.

The following persons are participating in the project and will have access to the requested data/biomaterial samples.

Please also indicate who has managerial authority over whom, including the applicant/group leader.

Name of group leader	Name of researcher (working on the project: data/ biomaterial)	Institution	Does the person have an employment relationship with the DZNE and intend to use the requested material for this relationship?
Yes: ☐ No3: ☐
Yes: ☐ No3: ☐
Yes: ☐ No3: ☐
Yes: ☐ No3: ☐
Yes: ☐ No3: ☐

3 In cases in which data/biomaterial samples are to be provided to external researchers (researchers who are not employed by the DZNE or – in case of a double affiliation – who don’t intend to use the requested material for their DZNE employment), a suitable contractual agreement must be concluded. Templates will be provided by CRP.

Are all recipients of the data and/ or biomaterial samples located in the European economic area?

Yes: ☐	No: ☐

Does the research proposal involve an industry cooperation?

Yes: ☐	No: ☐

I hereby request Data/biomaterial samples from the following study(ies):

Study: [add Study Name] ☐ Baseline ☐ Follow-up	Study: [add Study Name] ☐ Baseline ☐ Follow-up	Study: [add Study Name] ☐ Baseline ☐ Follow-up

I am requesting only local data/biomaterial samples generated in our group.

Yes	☐	No	☐

Data/biomaterial samples from Number of study participants (≥ or =) are required.

Definition of subpopulations, if applicable:

Type and amount of required data/biomaterial samples:

Please use the Clinical Data Search Tool (CDST) [>https://www.dzne.de/forschung/forschungsbereiche/klinische-forschung<] to select data and/or samples by checking the tickbox for complete forms or the items needed. The selection should then be printed (pdf) and added to the request.

Please specify, also specifying the scales/data/samples used:
☐ Clinical data
☐ Neuropsychological data
☐ Imaging data
☐ Biomaterial samples (type)2	Select one element. Number of samples/test person: _________
☐ Other data

2 If you require additional biomaterial sample types, please include additional lines.

Is the project covered by an existing ethics commission vote?

Yes	☐	(Please attach a copy of the positive Ethics Committee vote.)

No	☐	(Attention: Without a positive Ethics committee vote, no data/biomaterial samples can be provided. In the	case of provision of biomaterial samples, a new Ethics committee vote is mandatory, if the purpose of the use	wasn’t part of the study protocol and subjects’ information. A template for submission to the Ethics committee	can be provided. iPSCs are exempt from this practice if provided without any further data (except for the genetic	Information). It is in the responsibility of the researcher to inquire whether the appropriate Ethics committee	considers a vote necessary.)

Name of the project:
Short summary of the project (including background, aims, hypotheses, description of the method to be used):
Statistical analysis (calculation of power and sample size as well as analysis plan):
Sample size estimation:	☐ not applicable
Argumentation:
Preliminary data	☐ available ☐ not available
Presentation of preliminary data: (e.g. with information such as the variation coefficient, the linearity of the assay and of previous tests/data; with specification of the number of analyzed samples/data, about validation in the context of an independent previous used cohort and the reason about the use of samples/data from the requested cohort):

If biomaterial samples are being requested have the methods planned for the project been established by the applicant and are proven functional for the requested type of biomaterial?

☐ Not applicable

☐ Yes	(Please attach suitable proof, e.g. proof-of-principle data or publication using the requested type of biomaterial.)

☐ No

Methods to be used (key points, short listing):

At the end of the project analysed parameters (scores, MRI, biomarkers etc.) including raw data (if applicable) have to be provided to CRP by the applicant. The data will be provided in the following format and with the following accompanying information:

Parameters to be analysed (biomarkers, scores, etc.):
Format (e.g. csv):
Information (e.g. concentration, pos./neg. controls, cut off values, analysis tools, method description, quality controls):

Requested third-party funding (if applicable):
Funding already granted?	Yes ☐ No: ☐
Planned duration of the project:	[From date – until date]

The requested data/biomaterial samples are to be provided to the person named below by [Date]:

Name of person and email	Institution (including address)
Data:
Biomaterial:

☐	I confirm that before publishing any results of the above-mentioned project, the DZNE project	management (projektmanagement.kf@dzne.de) has to be contacted concerning the author list and	acknowledgements.

I hereby confirm that I have taken due note of, and will observe, the regulations for use of Clinical Research databases, data and biomaterial samples of the DZNE. I promise to use the data/biomaterial samples only in the framework of the above-named project, and will not provide them to third parties, under any circumstances. In addition, I will accordingly instruct all persons over whom I have managerial authority.

I hereby confirm that I will provide any kind of analysis data of the provided data or biomaterials including documentation and used methods to the Data Management of the CRP once the analysis data are no longer needed for pending publications or patent rights.

I hereby confirm that I will immediately cease the use of the data/biomaterial upon termination or expiration of the right to use data/biomaterial or upon request of DZNE due to the obligation to delete data according to data protection regulation and will delete all data and destroy biomaterial without delay. Without any further request, I will confirm DZNE (Data.ManagementKF@dzne.de) immediately, in writing, that I have fulfilled these obligations.

Requested by: (Applicant)
Signature	Date

Requested by: (Group leader, if applicable)
Signature	Date

Please add additional signature spaces as necessary.

Signatures of the persons involved in the project over whom the applicant/group leader does not have managerial authority :

Requested by:
Signature	Date

Requested by:
Signature	Date

Please add additional signature spaces as necessary.

Please e-mail the application to klinische-studien@dzne.deRequest forms for access to clinical studies must be submitted at least 8 days prior the respective steering committee meeting in order to allow initial validation and circulation to the committee members.

The following section is to be filled out by the Quality assurance of the Clinical Research Platform:

Data/Biomaterial request form: _____________________________

For provision of the requested data/biomaterial samples the following documents have to be at hand:

Required documents	Available?
Ethics committee vote that covers the project	Yes: No:
Agreement on use of data	Yes: No:
Material Transfer Agreement	Yes: No:

The request form will be forwarded to the	Clinical Board

Steering Committee

AG Biomaterial

n/a (if the applicant has requested only his/her own data)

Reviewed by:
Quality assurance [First name last name]	Date

If the approval of the Clinical Board or Steering Committee is required, the following section is to be filled out by the head of the CRP:

The Clinical Board/Steering Committee has decided to approve the data/biomaterial request for the described research project.

Yes (without restriction)	No

Yes (with restriction):

The decision of the Clinical Board/Steering Committee was made on: ____________________

Confirmation by the head of the CRP:
Dr. Annika Spottke
First name Last Name (please print)	Date	Signature