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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
The standard application procedure for clinical trial authorisation is as follows:
- The applicant submits an online request form to the European Medicines Agency for a EudraCT number for registration of the clinical trial (required for all clinical trials conducted in the European Union). The applicant will receive the number by email.
- The applicant (or its legal representative with a permanent place of business in the European Economic Area) submits a formal application to Federal Institute for Drugs and Medical Devices (BfArM) or the Federal Institute for Vaccines and Biomedicines (PEI), as the case may be (Section 42(2) of the Medicinal Products Act). The application must be submitted along with certain documentation, including:
- the EudraCT number;
- the study protocol;
- the active pharmaceutical ingredient dossier;
- proof of insurance;
- informed consent forms;
- sponsor details;
- details on the principal investigator and principal institution; and
- inclusion criteria regarding study subjects (Section 40 and following of the Medicinal Products Act and the Ordinance for Good Clinical Practice).
- The applicant submits an application for approval with the responsible ethics committee of the competent German federal state (Section 42(1)(2) of the Medicinal Products Act).
- After receipt of the aforementioned approvals, the competent supervising authority of the federal state is notified of the clinical trial (Section 67(1)(1)(5) of the Medicinal Products Act).
In future, the approval procedure will change due to the new EU Regulation on Clinical Trials (536/2014, CTR) and respective German provisions, which will both likely apply by the second half of 2019. Applicants will be able to submit a single application dossier to the EU-Portal. The submitted application dossier will be accessible through the EU-Database to all EU member states in which the applicant wishes to conduct the concerned clinical trial.
How robust are the standard good clinical practices followed in your jurisdiction?
Very robust. No marketing authorisation is granted where any infringement of good clinical practices is detected and not remedied.
Marketing authorisation depends on (among other things) adherence to good clinical practices, which must be confirmed by documentation in the application dossier.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
Reporting and documentation of clinical trials are regulated by Section 42b, 67a (2) Medicinal Products Act and the Ordinance for Good Clinical Practice (Section 12).
With respect to medicinal products requiring marketing authorisation, the pharmaceutical entrepreneur must publish reports on all results (including unfavourable results) of confirmatory clinical trials substantiating the efficacy and safety of the product within six months of the grant or modification of the marketing authorisation. In addition, the sponsor must submit a summary of the clinical trial report to BfArM or the PEI.
In future, all relevant information in connection with clinical trials shall be submitted to the EU-Portal/EU-Database. The information is then publicly available via these two databases (Article 81(4), EU 536/2014) – with exceptions (eg, personal data of trial subjects). The European Medicines Agency defined criteria for determining any data that requires protection and thus will not be publicly available.
What are the informed consent obligations with respect to clinical trial subjects?
Consent must be given in writing, after the clinical trial subject has been informed of the nature, intent, risks and importance of the clinical study.
Clinical trial subjects must also consent to the purpose and extent of the collection, storage, processing and use of their personal and sensitive data in the course of the clinical trial, as well as potential processing by third parties during or after the term of the clinical study.
What are the insurance requirements for clinical trials?
Clinical trial subjects participating in a clinical study must obtain specific insurance coverage appropriate to the risks involved. The insurance coverage must be at least €500,000 for death or permanent inability to work.
What data protection issues should be considered when conducting clinical trials?
The collection, processing and use of personal or special categories of personal data is generally permitted only where such processing is permitted or ordered by law, or the data subject has given prior consent to the processing. Stricter rules apply where special categories of data – such as health data, biometric data – are processed.
Informed consent must be obtained from each clinical trial subject before participation in any study. The informed consent form must cover several topics, including the nature, intent, risks and importance of the clinical study. Consent forms are part of the dossier that must be provided to the authority in the course of the marketing authorisation procedure.
The pharmaceutical entrepreneur, as sponsor of the clinical study, is the data controller and must take into account that the clinical trial subject may revoke consent at any time. The clinical trial subject also has a right to information at any time with respect to the type and amount of personal data processed by the sponsor or contract research organisation in the course of the clinical trial, provided that the data has not yet been anonymised. Consequently, the sponsor or contract research organisation must implement specific procedures to:
- provide the clinical trial subject with information on his or her processed personal data on request; and
- delete any such data on the clinical trial subject’s request.
Various issues should be considered with respect to data protection for biomaterial samples, including:
- data protection issues regarding the personal data in connection with the sample;
- proprietary issues regarding the samples itself; and
- the subject’s personal privacy rights to the sample’s further use by the sponsor, contract research organisation or any third parties.
Article 35 of the General Data Protection Regulation requires a data protection impact assessment (PIA) before processing special categories of data. A company must assess the impact of the envisaged processing operations on the protection of personal data. The PIA will in particular include a systematic description of the envisaged processing operations and the purposes of the processing, including, where applicable, the legitimate interest pursued by the company. It will also consider the risks to the rights and freedoms of data subjects. Assessment will be documented.
Where personal data is transferred to third parties in the course of a clinical trial, appropriate data transfer agreements should be put in place, in particular where the recipient is located outside the European Economic Area.
Specific data retention rules apply in the course of and after the term of a clinical study (Section 40 of the Medicinal Products Act and the Ordinance for Good Clinical Practice).
The law imposes notification obligations in case of data breach involving special categories of personal data, provided that there is a threat of serious harm to the data subjects' rights or legitimate interests. Where special categories of personal data are unlawfully disclosed, the data controller must immediately notify the responsible authority and the data subjects.
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