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Study Management – Master Schedule, Protocols & Reports

Master Schedule Management

  • The study registry module is utilized to write the protocol and includes the minimum required fields for a Master Schedule as defined in the CFR Title 21 Part 58 GLP requirements for a master schedule. User can add an unlimited number of fields to automate the protocol and report writing process. The specific fields for a master schedule can be selected during the report generation and saved as a Master Schedule report template.

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Protocol Management

  • Protocol creation is managed through the study registry module. Labwise allows users to configure specific forms for creating protocols through a questionnaire process. These fields are automatically populated into a Protocol document when electronically printed. The protocol can then be sent through various workflow configurations for review, approval, and distribution.

Report Management

Report creation is managed through the study registry module as is the Protocol. Since much of the content and information in the protocol is often re-typed into the various study reports such as the Pathology report, Toxicokinetic report, Clinical Pathology report, Labwise automatically populates the information from the protocol without typographical errors.

Labwise allows users to configure specific forms for creating these reports through a questionnaire process. These fields are automatically populated into the report document when electronically printed. The reports can then be sent through various workflow configurations for review, approval, and distribution.

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