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The Monitor's SuiteTM is an integrated, flexible set of database tools specifically designed for Clinical Research Study Monitors, Project Managers, and Quality Assurance Auditors. The system permits easy entry and rapid retrieval of information with respect to clinical study sites, subjects, regulatory files, data quality and test articles. Designed for use on site or in-house, the system can utilize notebook and/or desktop computers, to facilitate:

  1. CRF data audits and their attendant data corrections.
  2. Creating an organized inventory of study file contents to ensure the presence of required regulatory documents and to help synchronize file contents at the study site, monitor and sponsor locations.
  3. Documentation and calculation of drug accountability and reconciliation for a wide variety of parenteral and oral drug formulations used in both in-patient and outpatient study settings.
  4. Maintenance of an up-to-date directory of clinical study site information.
  5. Generating Status Reports from a current subject roster in one or more single or multi-center studies.

The Monitor's SuiteTM is an application consisting of an integrated set of database templates for FileMakerĀ® Pro for Windows (version 3.0 or later), and requires the proper installation and operation of licensed FileMakerĀ® Pro and Windows 95/98 software.

The Monitor's SuiteTM applications are designed to aid in managing and monitoring clinical research studies. These applications are not designed or validated for the recording or storage of clinical research data or other research data management purposes, and should not be used for such. Changes to the content of database files may be made freely without the creation of an audit trail.

The Monitor's SuiteTM Applications

  1. THE FRONT OFFICE - Contains basic information about the studies, including project names, the names, addresses and phone numbers of responsible site & sponsor/monitor personnel, study formulary references and other related information.
  2. ADMITTING - Contains basic subject demographic, Informed Consent, stratification and study status information for each study subject. Provision is made for capturing the dates of significant on-study events so that subject time line reports, as well as project status and subject demographic summaries can be generated.
  3. FILE ROOM - Provides for the maintenance of an easily searchable inventory and index of study file documents. A standardized, editable, menu list of documents is provided, along with a user customizable classification system which allows related document types to be listed together. Documents may be logged in at up to 3 file locations to facilitate the synchronization of study file contents between the Sponsor, Monitor and Study Site locations.
  4. MEDICAL RECORDS - Provides a standardized, customizable, system for documenting the audit and review of source documentation (Medical Records) to confirm the accuracy and completeness of CRF data elements. Provision is made for noting and categorizing specific data discrepancies, and generating detailed audit reports and correction forms to document the presence, and subsequent resolution, of noted problems. Through a relationship with ADMITTING, a timeline of significant on-study events is displayed to facilitate conduct of the data review.
  5. PHARMACY - Provides a system for drug accountability and reconciliation which compares study drug dosing (as recorded on Subject CRFs) with independent records of study drug receipt, dispensing and return. Single dose parenteral, multi-dose parenteral, oral liquid and oral solid dosage forms are accommodated in both the in-patient and out-patient settings. Reports are generated detailing individual Subject dosing compliance and overall study site test article accountability & reconciliation. Up to six distinct drug formulations, with single or multiple lots of each, are accommodated for each individual study.