• (919) 844 2494
  • Warning Letter: Failure to capture electronic data (ucm399364)

    Tags:

    Ofni Systems

    AMKS TRL monitoring failed to identify and correct a clinical investigator’s failure to collect study subjects’ data on protocol-specific case report forms (CRFs), as required by Protocol [redacted]. We note that during the inspection, you indicated that AMKS TRL did not use any paper CRFs or electronic data capture to record study subjects’ data.

    View the original warning letter.

     

     


    Recommended Solutions

    Compliance Training >>

    Recommended Solutions

    ExcelSafe >>

    Recommended Solutions

    Ofni Clinical >>

    Recommended Solutions

    Part 11 Toolkit >>

    Recommended Solutions

    Part 11 Advisor >>

    Recommended Solutions

    MedWatch Reporter >>

    Recommended Solutions

    Computer Validation >>

    Recommended Solutions

    Custom Programming >>

    Recommended Solutions

    Validating MS Excel Spreadsheets >>

    Recommended Solutions

    Access Databases >>