A clinical trial on humans is any study conducted on humans that is intended to investigate or prove the clinical or pharmacological effects of medicinal products or to determine side effects or to investigate absorption, distribution, metabolism or excretion with the aim of ascertaining the safety or efficacy of the medicinal products.
Non-interventional trials of medicinal products (observational studies, NIS) must be notified to the competent higher federal authority (§ 67 AMG). These studies are advised by the Ethics Committee in accordance with Section 15 of the Professional Code of Conduct for Physicians in Baden-Württemberg.
Therapeutic trials are not subject to consultation by the ethics committee in accordance with the professional code of conduct for doctors, as this would interfere with the doctor's freedom of therapy.
With the entry into force of the Regulation on clinical trials on medicinal products for human use (Regulation (EU) No. 536/2014 ), the procedure for submitting applications in the EU has changed, among other things. From January 31, 2023, all applications for new clinical trials in the EU must be submitted via the Clinical Trial Information System.
Further information:
Higher federal authorities BfArM (Federal Institute for Drugs and Medical Devices) and PEI (Paul-Ehrlich-Institut)
Klinische Prüfung eines Arzneimittels
Application
Application documents
The complete list of documents that must be submitted to the Ethics Committee can be found in § 7 of the GCP Regulation.
Tübingen is responsible (in charge):
Initial application, amendments and late notifications: One paper copy and one CD with all documents.
Tübingen is a participating ethics committee:
Initial application: A cover letter and a CD.
Amendments: Electronic application by e-mail or a cover letter and a CD.
Subsequent applications: One paper copy and one CD
The following documents must also be enclosed:
the completed checklist
the EU application form
Proof of qualification for examiners and deputies
Description of the test group and the test center
a complete list of all documents
General information and advice on submitting applications and on the qualifications of investigators and review bodies as well as sample texts and application forms can be found on the website of the Working Group of Medical Ethics Committees in Germany.
Arbeitskreis Medizinischer Ethik-Kommissionen
Applications for clinical trials with human medicinal products are submitted via the Clinical Trials Information System (CTIS). The Ethics Committee is informed via an automated electronic procedure that an application has been received.
Clinical Trials Information System – CTIS
The application for a favorable assessment by the Ethics Committee must contain the documents and information listed in Annex I CTR (Regulation (EU) No. 536/2014).
The procedure is divided into an Assessment Report Part I and an Assessment Report Part II. In the assessment report Part I, the responsible ethics committee examines whether the requirements of Art. 6 (EU) Regulation No. 536/2014 have been met with regard to the protocol and the trial information as well as the benefit-risk assessment. The assessment report Part II concerns the requirements for consent, recruitment, the suitability of the trial site and the persons involved in the conduct of the trial. Art. 7 of Regulation (EU) No. 536/2014, which regulates the procedure for Part II, contains the requirements for data protection, insurance and the handling of biomaterials. Section 40 (4) and (5) of the AMG stipulates that the ethics committees issue an opinion for the Part I and Part II assessment reports.
To simplify matters, the Working Group of Medical Ethics Committees has produced sample texts for patient information, which are linked here.
Self-initiated non-commercial clinical trials according to the AMG
Due to its status as as an institution under public law, the University Hospital Tuebingen acts as a sponsor for self-iniated studies within the clinic ("investigator-initiated srtudies"). Important information on this can be found in circular RS08/13 UKT/MFT (conducting self-initiated AMG studies)
The following documents must also be submitted to the Ethics Committee:
- A written declaration from the hospital's board of directors regarding the sponsorship,
- a power of attorney for you or the Medical Director of your clinic as the sponsor's representative, so that you can also fulfill the sponsor's obligations in the external relationship,
- all contracts concluded with participating test centers or external sponsors.