Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover subsequent questions and challenges

Module 1

Project Definition:  Understanding your clinical trial and your resources

• Begin with the end goal. Programme or single clinical trial?
• Who will support project delivery?
• RACI: Activity Design your RACI
• Understand the roles and responsibilities at Sponsor, CRO, Vendor, Technology providers and Investigational sites
• Stakeholders
• Activity: Understand your team

Module 2

Protocol design to protocol deviations

• Inherent Quality by Design (ICH E8 R1 and ICH E6 R3)
• Critical to Quality Factors
• Promoting High-Quality Studies
• Defining Study duration
• Minimising the number of Protocol amendments
• Minimising the number of Protocol deviations
• Managing Protocol Deviations
• Activity: Poor Design, Poor Delivery

Module 3

Project risk analysis and management

• Project Risk Analysis and Management for Clinical Trials
• Driven by ICH E6(R2) Good Clinical Practice
• Centralised and Risk Based Monitoring
• Risk Indicator Library and how to use
• Activity: Work with Key Risk Indicators

Module 4

Selection, contracting and oversight of vendors

• Selection of Vendors to deliver your protocol
• Contracting with Vendors
• Oversight of Vendors to meet regulatory expectations
• Technology in Clinical Trials

Module 5

Prioritise, plan and enrol evaluable subjects

• Effective Study Feasibility: And now for the patients
• Estimate Study Enrolment and produce Enrolment Plan
• Communication of Clinical Trial Priorities: Activities essential to the project
• CASE STUDY: It all went wrong before it even started
• Activity: Patient Recruitment challenge

Module 6

Crises, issue management and CAPA’s

• Clinical Trial Crises
• Issue identification and management
• CASE STUDY: Protocol Adherence during COVID-19 Pandemic: Budget impact?
• Activity: Patient Recruitment Issue
• Corrective And Preventive Action (CAPA) plans
• Clear issue documentation for ongoing Inspection Readiness.
• Activity: Use of root cause analysis

Module 7

Budget Planning and Management

• FTE calculations
• CRA resource allocation
• Activity: Budget Understanding
• CASE STUDY: Protocol adherence during COVID-19 Pandemic Budget Impact
• TMF

Module 8

Clinical trial close out

• LPLV to Database lock = 5 business days
• Site Close Outs
• Budget and Contracts Close Out
• Technology close out/finalisation and archive
• Inform Regulatory Agencies study has closed/completed/terminated
• Study Close and Document Archiving
• eTMF final QC, close out and archive
• Lessons Learned for subsequent studies
• Activity: Lessons learned

Julianne Hull – With 30+ years of global leadership experience within the pharmaceutical industry, Julianne has broad and in-depth knowledge of how Clinical Trials work. Having been a global leader for operations planning and vendor management within Wyeth she established and led the fora to ensure collaborative cross-functional delivery of all phase 1 to 3 clinical studies. Julianne has worked in the large, medium, and small pharma providing valuable perspectives on the varying constraints and enablers to project delivery.

Julianne delivers training programmes globally on several different clinical topics bringing her real-life experiences to the classroom. Julianne has an easy and interactive style which ensures the class engage and take the most from the training.