PhOSCo Trial Progress Manager - Outline specifications

General

Standalone module to standard PhOSCo specifications.

Principally enquiry and reporting on Trial Progress, while allowing setup of standard resource specifications, trial planning, and budgetary information. Limited data entry.

All reports to be generated in HTML format, displayed in scrolling window, with standard ui functionality to save in native HTML or as PDF file.

All Charts to be displayed in scrolling windows, with standard ui functionality to allow save of graphics in PDF, PNG, and JPG format.

All Charts to use "Tooltip" type displays for data in context

Where applicable, "drill-down" functionality from summary/overall charts to detail.

Read Trial Metadata

Count

  1. Number of Visits
  2. Number of Pages
  3. Number of Required questions
  4. Total Questions
  5. Sites

Count numbers of questions within Visits and Pages

Count total number of planned subjects and by site

Configure Trial resource definitions

Set up table JCTRES for this trial and database. Allow import/export of XML data definitions.

Configure recruitment master schedule

To be held as Trial System annotation record for each site: calendar of planned recruitment

Configure Primary budgetary schedule

To be held as Trial System annotation record.

Configure Budgetary expansion rules

To be held as Trial System annotation records.

Entry of Subject Resource usage

Allow entry of SUBJRES table data. (Separate module? import of XML data?)

Analyse Trial Progress

Chart: Recruitment by Site. Planned vs Actual Subjects by Site, show screened, medicated, followup, completed, withdrawn, died.

Chart: Progress by Site. Required and optional questions answered by subject within site against totals, plus averages by site.

Chart: Overall Monitoring Progress

Chart: Projected completions analysis.

Adverse Events

Chart: Adverse events by site. "Normal" and Severe AEs by site, categorised by death, withdrawal, continuing. Totals & average per subject.

Resource Usage

Chart: Total costs per site, planned vs Actual

Chart: Resource usage and cost per Resource, planned vs Actual

Chart: Resource usage and cost per Subject, planned vs Actual

Site Performance

Chart: Communications status by site

Chart: Bad data and exceptions by site

Chart/Report: Monitoring progress

Chart/Report: SDV progress

Data Point charts

Chart: Histogram of DP values for all subjects

Chart: Scatter Plot of DP values for all subjects against another DP value