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What are the requirements for first-in-man clinical trials from a clinical point of view? Date: 02. December 2008 Topics: Licensing Type: FAQ

The trial protocol of first-in-man clinical trials involving a novel substance should include a critical discussion of whether the new investigational medicinal product is a potential high-risk medicinal product. The draft GUIDELINE ON REQUIREMENTS …

What is meant by "justification for sex distribution"? Date: 02. December 2008 Topics: Licensing Type: FAQ

In this context, applicants can specify that in the course of data analysis, stratification according to sex will be performed. If no sex-specific differences are meant to be investigated within the clinical trial, there should be an …

Which documents are to be submitted as a final clinical trial report? Date: 02. December 2008 Topics: Licensing Type: FAQ

It is not necessary to submit the entire final clinical trial report; submission of the trial synopsis is sufficient. A paper version of the trial synopsis is to be submitted, however, additional electronic submission would be greatly …

How long is the sponsor obliged to keep the documents of a clinical trial? Date: 02. December 2008 Topics: Licensing Type: FAQ

In accordance with Section 13 sub-section 10 of the GCP Ordinance, the sponsor shall ensure that the important documents of the clinical trial, including the protocol, are kept for at least ten years after the end or termination of the trial. …

Does the final clinical trial report have to be submitted to the national competent authority? Date: 02. December 2008 Topics: Licensing Type: FAQ

In accordance with Section 13 sub-section 9 of the GCP Ordinance (GCP-Verordnung), a summary of the clinical trial report shall be submitted to the national competent authority within a year after the end of the trial, covering all important …

Does the final clinical trial report have to be submitted one year after completion of the clinical trial in Germany or one year after completion of the trial worldwide? Date: 02. December 2008 Topics: Licensing Type: FAQ

Since a final clinical trial report can only be prepared after worldwide completion of the trial, the one-year period is calculated starting from the actual date of trial completion.

What needs to be considered in paediatric trials? Date: 02. December 2008 Topics: Licensing Type: FAQ

The cover letter shall state that it is intended to include minors in the clinical trial. We recommend describing as early as in the cover letter, how the following regulations will be implemented:

Pursuant to Section 40 sub-section 4 …

Is it possible to omit preclinical data in the IMPD? Date: 25. November 2008 Topics: Licensing Type: FAQ

Yes, in a simplified submission the preclinical section in the IMPD can refer to the corresponding IB section. In this case the IMPD layout should be used (see 15.). On the other hand, please keep in mind that the preclinical section in the IB

When should the applied doses in preclinical studies be declared in mg/kg as well as in mg/m2? Date: 25. November 2008 Topics: Licensing Type: FAQ

This is necessary if the dose for the use in humans is also declared in mg/m2 body surface.

Which guidelines in general are important for preclinical safety testing and documentation (IB, IMPD)? Date: 25. November 2008 Topics: Licensing Type: FAQ

The following guidelines are at minimum to consider (list is not complete):

  • ICH M3(M): CPMP/ICH/286/95

  • ICH S6: (Biotechnology) CPMP/ICH/302/95

  • ICH S7A: (Safetypharmacology) CPMP/ICH/539/00

  • ICH S7B (QT …