Documents to be submitted (each as a separate PDF):

The following documents are mandatory for every application:

• Completed application form
• Structured synopsis in German, with version and date
• Study protocol according to checklist variant A, with version and date in the header or footer of the document
• Signature page for the study protocol (signed by the principal investigator)
• List of participating study centers including the locally responsible physicians, with version and date in the header or footer of the document
• Declaration of suitability of the study center and consent of the clinic/institute management
• Details of funding and Cost absorption declaration OR confirmation from the thesis supervisor

The following documents must be submitted if applicable to the research project applied for:

• Information leaflet(s) with version and date in the header or footer of the document
• Consent form(s) with version and date in the header or footer of the document
  Please note: For studies with minors, age-graded information and consent forms for minors adapted to the respective target group as well as an information and consent form for parents/guardians must also be submitted. For studies involving adults incapable of giving informed consent, separate information and consent forms must be submitted for patients who regain the ability to give consent and for legal representatives. The decision tree at the end of the page can be used as support for the decision, which information and consent materials will be required.
• Application for fee reduction/fee waiver
• Statements from other ethics committees
• Questionnaires, with version and date in the header or footer of the document
  Please note: Only questionnaires that have been developed for the research project must be submitted. Standard questionnaires, e.g. on quality of life, etc. do not have to be submitted.
• Data collection forms or eCRF (as PDF or screenshot), with version and date in the header or footer of the document
• Recruitment material
• Grant proposal (e.g. DFG, BMBF, etc.), with version and date in the header or footer of the document
• Cost calculation
• Contractual agreements with the study centre, including details of the compensation
• Insurance policy and insurance conditions
• SmPC(s) e.g. for NIS
• Instructions for use, e.g. for studies with medical devices/IVDs
• Power of attorney for study correspondence 
  Please note: A power of attorney is only required if persons other than the local principal investigator are to receive study correspondence. The authorization must contain an email address of the additional recipients and be signed by the local PI.

The following table provides an overview of the documents that require a signature, a version and a date in the document.

Decision tree for the required information leaflet(s) and consent form(s)

You can use this decision tree to determine which information leaflet(s) and consent form(s) you will need for your study. Please note that you may need several types of informed consent documents depending on the collective(s) that will be included in your study.