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.

201 Markham Hollow Road, Tully, New York 13159
315.696.8139 315.668.6043
Fax: 315.696.8722
E-Mail: qaaudits@aol.com