Project/Engagement Technical Assumptions- review key elements of the project or engagement (e.g. countries for engagement, other third-party providers used, SOPs followed, tools/templates used, etc.) Share and discuss execution related assumptions Joint- Sponsor and CRO Project Leads Comm Tool 20 - Master Class Setting Expectations Worksheet Project/Engagement Quality Assumptions- review definitions for quality Gain agreement of quality expectations Facilitator Avoca Quality Agreement Template Create/Confirm Milestones- Define key deliverables and delivery dates Gain agreement on key deliverables and delivery dates, including interdependencies and prerequisite activities Joint- Sponsor and CRO Project Leads Tech Tool 02- Project Management Oversight Roles and Responsibilities- RACI Charting for each deliverable Gain agreement on key accountabilities and responsibilities; clarify when Sponsor should be consulted or should provide approval vs. being informed; avoid micromanagement by Sponsor Facilitator or CRO Project Lead Roles and Responsibilities Guideline, RnR Tool 04- Using RACI Charting and Analysis, RnR Tool 06- Template RACI Chart Risk Identification- Review potential risks to quality and timely delivery of milestones and key deliverables. (If a functional engagement, involve all functions.) Proactive planning to understand challenges CRO Project Lead and Deliverable Owners Risk Tool 01- Elements of Risk Management, Risk Tool 07- Risk Management Plan Template Confirm/Categorize Risks- assign probability (high, medium, low), assign impact severity/criticality (high, medium, low) Proactive planning to prioritize risk management CRO Project Lead and Deliverable Owners Risk Tool 05- Provider Risk Assessment and Mitigation Develop Mitigation Plans/Contingency Plans- Focus on high probability, high impact risks. Discuss metrics and detectability, establish mitigation plans, and consider the Proactive planning allows rapid response to indications that a risk is being realized. CRO Project Lead and Deliverable Owners Risk Tool 06a- Risk Prevention and Detection Controls, Risk Tool 07a- Risk Oversight Table
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
protocol, issue escalation and resolution, etc. with expectations for timing, testing, documentation of completion, refresher training, new hire training, training oversight Review of Action Items and Parking Lot Topics- ensure all action items have an owner assigned, target date for completion and mechanism for communicating completion Tie up loose ends and ensure complete follow up after the meeting Facilitator Comm Tool 12- Action Item Template