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PDF ICH HARMONISED GUIDELINE

1 INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE ICH E6(R2) INTRODUCTION Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing conducting recording and reporting trials that involve the participation of human subjects

  • Is propagation over self-condensation consistent with the cGCP behavior?

    On the basis of the geometries, energies, and vibrational frequencies obtained, the propagation is 8.6 × 10 3 -fold greater than that for the self-condensation and hence is consistent with the CGCP behavior in that propagation was observed exclusively over self-condensation.

  • What information should be included in a GCP notification?

    Any notification/submission should be dated and contain sufficient information to identify the protocol. The name and address of the investigator's/institution’s IRB/IEC. A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws and regulations.

  • What is the ICH GCP guideline?

    The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

  • What does GCP stand for?

    The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

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