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Regulations in the Clinical and Preclinical Field



 
 

 

Regulatory requirements

Review of formal and regulatory requirements in the clinical field, HTA and for publication is a prerequisite for success. Even in the preclinical field, in phase 1 (also in the so-called phase 0), there are requirements that can be met by following protocols. In phase 2 and 3 the protocols are less flexible and more detailed. See US Code of Federal Regulations, Title 21, Vol. 5, Parts 300-299: Part 312: Investigational New Drug Application, Subpart B: Section 312.23 (a) (6)

 

 

Examples:

Formal standardization

  • Standard Operating Procedures (SOPs)
  • (electronic) Case Report Forms (CRFs, eCRF)
  • Electronic Data Capture systems (EDC)

Guidelines

  • International Conference of Harmonization (ICH) guideline
  • Good Clinical Practice (GCP)
  • Good Manufacturing Practice (GMP) (vgl. EudraLex Volume 4, Annex 13 In USA ist die GMP die Praxis, auch wenn keine Pflicht.)
  • Nuremberg Code
  • Declaration of Helsinki

Institutions

  • Investigational Review Board/Institutional Ethics Committee (IRB/IEC)
  • The Committee for Medicinal Products for Human Use (CHMP)
  • European Medicines Agency (EMA)
  • EU - investigational medicinal product dossier (IMPD).
  • Institutional Review Board (IRB)
  • Independent ethics committee (IEC)
  • Research ethics board (REB)

 

 

 

 

 

 

 

 

 

 


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