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Completely web-based data capture using standard browser |
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No special software, hardware, or plug-ins. |
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Real-time access to all clinical trial data. |
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Intuitive fill-in-the-blanks web-forms (e-CRF) with Radio button choices, Checkboxes, Drop-down selections and unlimited text boxes for comments |
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Real-time data entry validation checks. |
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Secure centralized database |
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Full back-end clinical data management and programmed data validation checks. |
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Full electronic and automatic Audit Trail tracking. |
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Simple e-mail query resolution or by on-line query database. |
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Fully configurable access rights. |
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Electronic signatures fully compliant with FDA's 21 CFR Part 11. |
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Several options for secure transactions using secure SSL server with encryption. |
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Can utilize personal digital certificates for authentication and digital signatures. |
| Optional services |
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e-CRF form design using |
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- Your forms in HTML format. |
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- Conversion of your electronic forms to HTML. |
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- Conversion of your paper forms to HTML. |
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- Designed from your protocol or other specifications to HTML. |
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- Conversion of static HTML code to programmed dynamic HTML forms. |
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Server selection |
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- HTTP server: |
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- Choice of three web sites operated by SyMetric Sciences for volume and bandwidth balancing. |
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- HTML pages in private directory with or without password protection. |
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- Secure SSL server (https) without digital certificates. |
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- Secure SSL server (https) with digital certificates used for digital signature |
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Workflow process |
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- Defined definitions for database views and functions according to access level |
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- E-mail notification tree for special events |
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Data validation |
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- On-line checks: Missing data, range checks, cross-item consistency, etc. |
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- Back-end data validation: Programmed cross-form checks, cross-patient, cross-visits, etc |
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Query resolution |
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- Queries e-mailed to investigator site contact. |
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- Queries cc. to sponsor. |
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- On-line query database |
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Database export |
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- Frequency of database exports: Daily, weekly, monthly, final only. |
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- Format of export database: ASCII, SAS, PDF form files with Table of Contents, other PC format. |
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