Ethikkommission

Submission is electronic via the electronic submission system. All required documents must be in PDF format and preferably PDF/A.

Einreichung

Please note

At present, only the system for the initial submission of a project is active in Graz. Subsequent submissions, addenda, reports, etc. should be submitted as previously on a data storage device (CD, DVD, USB stick, etc.) or by email. The only paper copy that must be submitted is the original application form with all required signatures (it can be turned in after the due date but must be in the office by the Thursday before the meeting). Meeting dates

The signatures must appear on a printout of the electronically submitted application form; the signed application form (including part B) must be identical to the electronically submitted form. Please use PDF files that are created electronically (readability, file size). Only pages with signatures must be scanned.

Documents to submit

Austrian Medicines Act trials (AMG)

The application is considered to be complete if the following documents have been included:

  • Cover letter including the list of submitted documents
  • Application
    • Application formincluding structured abstract in German (point 7) with all required signatures
    • Explanations
    • Sample completed form
    • Please note that the application form is created in the ECS system according to your input; if an application is complete and has been submitted, you can print the ECS application, sign it and deliver it to the Ethics Committee.
  • EudraCT formand documents in accordance with EU directive 2001/20/EC
  • List of amounts and modalities for any reimbursement or compensation of investigators and trial participants and the relevant elements of every contract between sponsors and the trial center (§ 41a par. 1 l 9 AMG)
  • Case report form (CRF) or screenshots of web-based CRFs
  • Study protocol or clinical investigation plan including any amendments
  • Investigator's brochure or Advisory Board on Medicinal Products report (for trials of drugs not registered in Austria)
  • Proof of the investigators' qualifications (current CVs)
  • Declaration of the investigators' conflicts of interest (Sample)
  • Proof of payment of the processing fee or application to waive the fee (no form, stating the reason)

If required:

If available/applicable:

  • Decisions of other ethics committees
  • Advertising material (ad text, posters, announcement, etc. including layout)
  • Patient card, patient diary, questionnaires, etc.

Multicenter AMG trials

The application is considered to be complete if the following documents have been included:

  • Cover letter including the list of submitted documents
  • Application
    • Application formincluding a structured abstract in German (point 7) with all required signatures
    • Part B (separate)
    • Explanations
    • Sample completed form
    • Please note that the application form is created in the ECS system according to your input; if an application is complete and has been submitted, you can print the ECS application, sign it and deliver it to the Ethics Committee.
  • EudraCT formand documents in accordance with EU directive 2001/20/EC
  • List of centers and list of local ethics committees to which a copy of the submission documents have been sent in accordance with § 41b par. 5 AMG
  • List of amounts and modalities for any reimbursement or compensation of investigators and trial participants and the relevant elements of every contract between sponsors and the trial center  (§ 41a par. 1 l 9 AMG)
  • Case report form (CRF) or screenshots of web-based CRFs
  • Study protocol or clinical investigation plan including any amendments
  • Investigator's brochure or Advisory Board on Medicinal Products report (for trials of drugs not registered in Austria)
  • Proof of the inspectors' qualifications (current CVs)
  • Declaration of the investigators' conflicts of interest (Sample)
  • Proof of payment of the processing fee or application to waive the fee (no form, stating the reason)

If required:

If available/applicable:

  • Decisions of other ethics committees
  • Advertising material (ad text, posters, announcements, etc. including layout)
  • Patient card, patient diary, questionnaires, etc.

MPG trials (with CE)

The application is considered to be complete if the following documents have been included:

  • Cover letter including the list of submitted documents
  • Antrag
    • Application form including a structured abstract in German (point 7) with all required signatures
    • Explanations
    • Sample completed form
    • Please note that the application form is created in the ECS system according to your input; if an application is complete and has been submitted, you can print the ECS application, sign it and deliver it to the Ethics Committee.
  • Case report form (CRF) or screenshots of web-based CRFs
  • Study protocol or clinical investigation plan including any amendments
  • Declaration of conformity (CE certificate), operator handbook
  • Proof of the investigators' qualifications (current CVs)
  • Declaration of the investigators' conflicts of interest (Sample)
  • Proof of payment of the processing fee or application to waive the fee (no form, stating the reason)

If required:

If available/applicable:

  • Decisions of other ethics committees
  • Advertising material (ad text, posters, announcements, etc. including layout)
  • Patient card, patient diary, questionnaires, etc.

MPG trials (without CE or outside the scope)

The application is considered to be complete if the following documents have been included:

  • Cover letter including the list of submitted documents
  • Application
    • Application form including a structured abstract in German (point 7) with all required signatures
    • Explanations
    • Sample completed form
    • Please note that the application form is created in the ECS system according to your input; if an application is complete and has been submitted, you can print the ECS application, sign it and deliver it to the Ethics Committee.
  • Case report form (CRF) or screenshots of web-based CRFs
  • Study protocol or clinical investigation plan including any amendments
  • Risk analysis and proof/confirmation of fulfillment of the basic requirements
  • Proof of the investigators' qualifications (current CVs)
  • Declaration of the investigators' conflicts of interest (Sample)
  • Proof of payment of the processing fee or application to waive the fee (no form, stating the reason)

If required:

If available/applicable:

  • Decisions of other ethics committees
  • Advertising material (ad text, posters, announcements, etc. including layout)
  • Patient card, patient diary, questionnaires, etc.

All other trials

The application is considered to be complete if the following documents have been included:

  • Cover letter including the list of submitted documents
  • Application
    • Application form including structured German abstract (point 7) with all required signatures
    • Explanations
    • Sample completed form
    • Please note that the application form is created in the ECS system according to your input; if an application is complete and has been submitted, you can print the ECS application, sign it and deliver it to the Ethics Committee.
  • Case report form (CRF) or screenshots of web-based CRFs
  • Study protocol or clinical investigation plan including any amendments
  • Proof of the investigators' qualifications (current CVs)
  • Declaration of the investigators' conflicts of interest (Sample)
  • Proof of payment of the processing fee or application to waive the fee (no form, stating the reason)

If required:

If available/applicable:

  • Decisions of other ethics committees
  • Advertising material (ad text, posters, announcements, etc. including layout)
  • Patient card, patient diary, questionnaires, etc.

Processing fee

General regulation

In accordance with the Forum of Austrian Ethics Committees recommendation, the Ethics Committee of the Medical University of Graz currently charges a processing fee of EUR 1,800 for the processing of trials.
This covers all future processing of the trial by the Ethics Committee, SUSAR and side effects, safety reports, amendments, etc.

The processing fee may be waived for non-commercially sponsored ("academic") trials upon request. To distinguish between academic and commercially sponsored trials, there is a leaflet on classifying projects as "commercially sponsored."

Regulation on multicenter drug trials

For multicenter drug trials, the following regulation is valid in accordance with a decision by the Forum of Austrian Ethics Committees:

  • If the ethics committee is considered to be a "main ethics committee," the processing fee is EUR 4,500. This fee covers—as applicable—the review of the trial as a "local ethics committee" for all centers within the purview of the ethics committee as well as all future processing of the trial by the ethics committee, such as SUSAR notifications, safety reports, amendments, etc.
  • If the ethics committee is considered to be a "local ethics committee," the processing fee is EUR 600. This fee covers the review of the trial as a "local ethics committee" for all centers within the purview of the ethics committee.

Payment

The processing fee should be paid to the following account:

  • Recipient: Medical University of Graz
  • IBAN: AT443800000000049510
  • BIC: RZSTAT2G, Raiffeisenlandesbank Steiermark
  • Reference: The internal order number (= A27703100009) and abbreviated title of the trial or protocol number must be included!

Notifications

Notifications of changes in the trial plan, incidents, terminations of the trial, etc. are continually accepted (without any submission deadline) and processed. In the event of amendments or serious, undesirable events, comments and a statement on any change in the benefit/risk ratio are required. Notifications should also be submitted electronically.

Externes Gutachten

External assessment by experts

The Ethics Committee reserves the right to allow applications to be examined by external experts. This assessment is comparable to the review procedure in a scientific journal. The external experts - who remain anonymous to the applicants - are obliged to treat the documents provided to them as confidential. The applicants may receive the assessment and make a statement.

Jaehrliche Begutachtung

Annual review

According to the ICH-GCP guideline (Good Clinical Practice), which includes at least one annual review of ongoing trials, a positive decision by the Ethics Committee is valid for one year from the date it was issued. If the trial lasts longer, an extension of the validity of a positive decision must be applied for in due time using the form for interim and final reports/application for an extension. These applications are handled like other notifications to the Ethics Committee, i.e., they are also examined at short notice outside the regular meetings. It may be necessary to handle them in a committee meeting.
Reports should also be submitted electronically.