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2. Clinical Data Interchange Standards Consortium - Wikipedia

   en.wikipedia.org/wiki/Clinical_Data_Interchange...

   Define-XML supports the interchange of dataset metadata for clinical research applications in a machine-readable format. An important use case for Define-XML is to support the submission of clinical trials data in CDISC SDTM, SEND or ADaM [11] format to regulatory authorities. The key metadata components to support submissions are: Dataset ...

3. Pharmaceutical Inspection Convention and Pharmaceutical ...

   en.wikipedia.org/wiki/Pharmaceutical_Inspection...

   Mutual recognition of inspection between member countries, so that an inspection carried out by officials of one member country will be recognized as valid by other members. Equivalent principles of inspection methodology, so that it is understood that inspectors in each member country will be following the same best practices when carrying out ...

4. Trial master file - Wikipedia

   en.wikipedia.org/wiki/Trial_master_file

   Article 57 of the Regulation requires that the TMF "shall at all times contain the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated", confirming that the trial master file should be maintained contemporaneously.

5. Investigational New Drug - Wikipedia

   en.wikipedia.org/wiki/Investigational_new_drug

   The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

6. Certificate of pharmaceutical product - Wikipedia

   en.wikipedia.org/wiki/Certificate_of...

   The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).

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8. European Union Clinical Trials Regulation - Wikipedia

   en.wikipedia.org/wiki/European_Union_Clinical...

   The single submission process for approval to conduct research in all EU member states is facilitated by the Clinical Trials Information System (CTIS). [3] CTIS is an online portal which enables interactions between clinical trial sponsors (that is, the organization responsible for the conduct of the clinical trial), and the regulatory ...

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