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