Clinical Trials

  • Cancer Clinical Trials
  • Detailed guidelines on good clinical practice specific to advanced therapy medicinal products

    Brussels, 03/12/2009
    ENTR/F/2/SF/dn D(2009) 35810

  • The rules governing Medicinal Products in the European Union Volume 10 - Guidance Documents applying to Clinical Trials

    QUESTIONS & ANSWERS SPECIFIC TO ADVERSE REACTION REPORTING IN CLINICAL TRIALS

    VERSION 1.0 (DECEMBER 2009)

  • Clinical trial Application Form

    REQUEST FOR AUTHORISATION OF A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS COMMITTEES IN THE COMMUNITY

  • Clinical trials submitted in marketing authorisation applications to the EMEA: Overview of patient recruitment and the geographical location of investigator site

    London, 23 September 2009
    Doc. Ref. EMEA/INS/GCP/58632/2009

  • The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe

    Greece (Update: April 2009)

     

    EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in the European Union

    Update of the Report, as of 2009

  • Project Final Report (ICREL)

    FEBRUARY 2009

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