costs and benefits of implementing mitigation plans. Assign ownership and target completion dates for mitigation activities. Define contingency plans with triggering thresholds. Assign ownership and target completion dates for contingency actions. Metrics and Status Reporting- Milestone Establishes focus on Facilitator or Metrics/Analytics/Technology Tracking, KPIs, KQIs, KRIs, etc. Determine milestones CRO Project Guideline; Comm Tool 21 - form, frequency and ownership Lead Project Status Report Third-Party Provider Presentations- Review Establishes clarity for all the Facilitator and Process Tool 05c- Project key procedures (lab data, ECG testing, etc.), parties involved Third-Party Provider Tracking Table data flow, key contacts and expectations Provider Representatives Communication Planning/Meetings- Define Establishes clarity of Joint- Sponsor Comm Tool 01- Communication communication mechanisms (email, expectations and ensures and CRO Matrix template, Comm Tool 02- meetings), frequency, approach rapid, appropriate Project Leads Communication Management (teleconference, face-to-face, etc.), purpose, communication; avoids Plan required vs. ad hoc attendees, roles and micromanagement responsibilities for agendas and meeting minutes, timing for submission of meeting minutes, expectations for email response times, back-up support, managing vacation calendars, team membership, contact information tracking, central document repository, etc. Issue Escalation Process- Establish how Ensures appropriate Comm Tool 03- Issue Escalation issues will be managed, communicated, escalation, timely resolution template, Comm Tool 04- tracked, etc. and avoid micromanagement Escalation Pathways Training Requirements- Define list of Establishes foundation for Joint- Sponsor Process Tool 03a- Process training requirements for data quality delivery and CRO Tracking Table systems, SOPs, therapeutic area/indication, Project Leads
costs and benefits of implementing mitigation plans. Assign ownership and target completion dates for mitigation activities. Define contingency plans with triggering thresholds. Assign ownership and target completion dates for contingency actions. Metrics and Status Reporting- Milestone Tracking, KPIs, KQIs, KRIs, etc. Determine form, frequency and ownership Establishes focus on milestones Facilitator or CRO Project Lead Metrics/Analytics/Technology Guideline; Comm Tool 21 - Project Status Report Third-Party Provider Presentations- Review key procedures (lab data, ECG testing, etc.), data flow, key contacts and expectations Establishes clarity for all the parties involved Facilitator and Third-Party Provider Representatives Process Tool 05c- Project Provider Tracking Table Communication Planning/Meetings- Define communication mechanisms (email, meetings), frequency, approach (teleconference, face-to-face, etc.), purpose, required vs. ad hoc attendees, roles and responsibilities for agendas and meeting minutes, timing for submission of meeting minutes, expectations for email response times, back-up support, managing vacation calendars, team membership, contact information tracking, central document repository, etc. Establishes clarity of expectations and ensures rapid, appropriate communication; avoids micromanagement Joint- Sponsor and CRO Project Leads Comm Tool 01- Communication Matrix template, Comm Tool 02- Communication Management Plan Issue Escalation Process- Establish how issues will be managed, communicated, tracked, etc. Ensures appropriate escalation, timely resolution and avoid micromanagement Comm Tool 03- Issue Escalation template, Comm Tool 04- Escalation Pathways Training Requirements- Define list of training requirements for data systems, SOPs, therapeutic area/indication, Establishes foundation for quality delivery Joint- Sponsor and CRO Project Leads Process Tool 03a- Process Tracking Table