Contents. Project Management: August 2005 Page 2 Clinical Research Operational Standards for Professional Practice for Professional Practice

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1 Project Management: August 2005

2 Contents Introduction About this standard: what is the importance of project management? Who has put this standard together? How should this operational standard be used? Acknowledgement Expert Working Group Members of the ICR CPD & Accreditation working party Performance Indicators Planning and Set-up Phase Project Plan Budget Resource Allocation Risk Assessment Start-up Phase Communicate the project plan to the project team Obtain agreement from the project team for all assigned roles and responsibilities, key milestones, timelines and budget Design and hold an effective and motivational start-up meeting that provides information and training on what is needed to achieve a successful outcome for the project Study Management Phase Project Management Status reports Team management Completion Ensure that the project sponsor receives all deliverables for the project as agreed in the project plan Evaluate the performance of the project team against the project plan s and Recommended Activities Planning and Set-up Project Plan Recommended Activities Budget Recommended Activities Resource Allocation Recommended Activities Project Management: August 2005 Page 2 for Professional Practice

3 Risk Assessment Recommended Activities Start-up Recommended Activities Study Management Project Management Recommended Activities Status Reports Recommended activities Team Management Recommended Activities Completion Recommended Activities Definition of Terms Abbreviations Bibliography Project Management: August 2005 Page 3

4 Introduction The Institute of Clinical Research (ICR), formerly known as ACRPI, was established in It is now recognised as the professional body for clinical research scientists in the UK. Two of the principle objectives upon which the organisation was founded are: to enhance the standards of clinical research carried out on behalf of the pharmaceutical industry and academic institutions, and to advance the professional competence of members. In collaboration with other professional bodies, the Institute has developed a range of Operational Standards for Professional Practice, to help meet these objectives. To complement the documents, ICR also runs a continuing professional development (CPD) scheme1. About this standard: what is the importance of project management? Drug development today requires effective project management skills on a global scale. Clinical projects generally require input from many different departments across the organisation thus requiring coordination across normal line management structures. In a number of organisations it is becoming increasingly common for projects to be contracted out in part, or in their entirety, to Contract Research Organisations (CROs). The project managers within these organisations must be able to work with different scenarios and to adapt to the requirements of different sponsors. This standard provides a reference for those working or hoping to work within project management in pharmaceutical, biotechnology, device or service environments. It assumes that a clinical development plan is in place and that there is an understanding of the basic project management tools and techniques. It is intended as an outline of the processes involved in successfully managing both single and multicentre clinical projects and to help guide the reader to the many well-accepted, detailed reference texts that are available. Who has put this standard together? ICR provides a forum for clinical research professionals with project management and study site management responsibilities to network and share best practice. A group of experts in the area formed a working party of clinical research professionals from both the pharmaceutical industry and service sector to develop this standard. It is based on extensive consultation with individuals and organisations representing the interests of clinical research professionals (in all, over 5,000 professionals). Further details of those involved in contributing, reviewing and in the consultation/approval process can be obtained from ICR. How should this operational standard be used? Each Operational Standard for Professional Practice consists of an introductory section, followed by a section with Performance Indicators, broken down by topic. The rest of the standard takes each topic and gives a, followed by a list of Recommended Activities. There is a final section Project Management: August 2005 Page 4

5 containing definitions, abbreviations and a bibliography. The performance indicators identified for each clinical research activity set the criteria for clinical researchers to be measured against. Individuals need appropriate skills and knowledge in order to achieve performance indicators. Expert working groups have identified areas of best practice which may be over and above regulatory requirements, but if followed, are believed to add value to the clinical study process and ultimately the standard of clinical research. Individual organisations have their own standard operating procedures (SOPs), but there is little formal cross fertilisation between companies. This standard outlines the recommended activities required to achieve the performance indicators and best practice. These are recommended activities, but for more specific instructions SOPs should be developed and utilised. Training providers can use this Operational Standard for Professional Practice as the standard against which they can gain accreditation of their course from the institute. Further information can be found on the website You may find it helpful to read this Operational Standard for Professional Practice in conjunction with the other ICR standards in this series. Project Management: August 2005 Page 5

6 Acknowledgement ICR would like to thank the Project Management Working Group and subsequent contributors and reviewers of this standard (listed below) for volunteering their time, sharing their expertise and experience and for their commitment and support for this important initiative. We would also like to acknowledge the support given by their companies. Expert Working Group John Armstrong Thomas Halliwell Bryan Hurst Blythe Mcdougall Danny Nasmyth-Miller Claire Roberts Ron Sloane Director, Clinical Development UK Head Project Management & Procurement Project Management Consultant Clinical Monitor Team Leader Senior Clinical Research Manager Training Officer Project Office Manager Members of the ICR CPD & Accreditation working party. List of associations consulted: BARQA, NHS R&D, TOPRA, MRC, ACDM, EMWA Project Management: August 2005 Page 6

7 Performance Indicators The following key performance indicators have been identified for each part of the project management process. Clinical research professionals must be able to: 1. Planning and Set-up Phase 1.1 Project Plan Develop a project plan with clearly stated timelines and milestones that are realistic, achievable and can be tracked Identify which standards are to be followed (for example which SOPs) Present the plan in a clear and understandable fashion, ensuring that assumptions and justifications are clearly documented Obtain agreement from stakeholders for the plan Establish a communication plan to ensure all stakeholder and team members are informed of the project progress, as required 1.2 Budget Ensure the budget that is in the clinical development plan is sufficient to allow a satisfactory outcome Ensure a process is in place to allow regular review of the budget against tasks and assumptions 1.3 Resource Allocation Identify resource needs based on the clinical development plan and budget Ensure sufficient resource is available and allocated to the project Establish a process to monitor individual and team performance, morale and turnover 1.4 Risk Assessment Identify and quantify potential areas of risk based on the project plan and assumptions Establish a process to review the risk on an ongoing basis ensuring sufficient contingencies are built into the plan based on risk analysis Create a tracking system to document and manage the risk for the project Project Management: August 2005 Page 7

8 2. Start-up Phase 2.1 Communicate the project plan to the project team 2.2 Obtain agreement from the project team for all assigned roles and responsibilities, key milestones, timelines and budget 2.3 Design and hold an effective and motivational start-up meeting that provides information and training on what is needed to achieve a successful outcome for the project 3. Study Management Phase 3.1 Project Management Proactively assess project progress against the project plan Implement the project contingency plan when the project is out of scope Communicate and obtain agreement from key stakeholders for any changes in the project plan that may affect the project s critical path 3.2 Status reports Provide accurate status reports providing a clear view of project progress and showing any major variance against plan 3.3 Team management Implement the project communication plan 4. Completion Obtain regular feedback on individual and team performance, morale and turnover Ensure that all team members have the right training to perform the project tasks 4.1 Ensure that the project sponsor receives all deliverables for the project as agreed in the project plan 4.2 Evaluate the performance of the project team against the project plan Project Management: August 2005 Page 8

9 s and Recommended Activities Planning and Set-up These best practice guidelines refer to the stages of project planning including definition of objectives, team identification and definition of the team s responsibilities, and budgeting. It assumes that there is a documented clinical development plan with clearly stated objectives, task assumptions and defined deliverables. Project Plan Work with the project sponsor to ensure that the project is feasible Consult with key project stakeholders to ensure clarity of objectives Build the project plan from the lowest activity up and ensure that it is based on realistic assumptions Define responsibilities and timelines within the project plan Ensure agreement from other relevant departments for the project plan Identify essential items to be incorporated into tracking systems that will assist reporting of project progress and decision making Recommended Activities a. Conduct a feasibility assessment to establish if the project is realistic and achievable b. Identify the activities to be incorporated in the project plan. Milestones may include: protocol writing commenced; protocol fully approved; regulatory and ethics approvals; first patient in; last patient out; database lock; report signed off; all sites and files closed c. Using suitable project management tools (such as project management software packages, spreadsheets, Gantt charts, paper) create a project plan to include key milestones, timelines, budget, resource allocation and links between tasks d. Identify and document project assumptions and quality standards to be achieved e. Establish a change request process to ensure that all project scope changes are agreed and documented f. Obtain and document agreement of the project plan from all project stakeholders g. Write a communication plan to ensure the flow of relevant information to all team members occurs in the most effective manner. The communication plan should include the nature of the communication, to whom it is directed, format, type and method of communication, as well as the frequency Project Management: August 2005 Page 9

10 Budget Build the project budget from the lowest activity up and ensure that it is based on realistic assumptions with reference to historical costs Recommended Activities a. Identify activities that have implications for either fixed or variable costs and incorporate them into the project budget. The budget should include: pass-through costs for travel, meetings, laboratory fees, service company fees, etc. b. Agree the budget with relevant stakeholders, e.g., department heads c. Develop a process for tracking and monitoring the budget Resource Allocation Consult with line managers to ensure efficient allocation and ongoing management of resource Recommended Activities a. Identify resource requirements for the project b. Agree the availability of the resource throughout the project with the relevant stakeholders, e.g., department heads c. If internal resource is not available as required, external resource should be obtained, e.g., from a CRO d. Assess the training needs of the project team and arrange for appropriate training to be provided, if necessary e. Establish a process to ensure the project is sufficiently resourced and that the allocation will be monitored and adjusted accordingly throughout the project Risk Assessment Ensure that a full risk assessment for the project is carried out and that suitable contingencies are built into the plan. Incorporate contingencies to cover pessimistic, realistic and stretch plans Recommended Activities a. Identify the areas of the project plan which, if not achieved as stated, could lead to a delay in the project deliverables, e.g., slow recruitment, staff turnover, protocol amendments b. Establish the likelihood of the risk occurring for the project and develop a plan for managing the risk should it occur c. Develop a tracking system to document and manage the risk for the project. The risk log should contain such things as: the description of the task/issue, date it was raised, likelihood it will occur, severity if it occurred, contingency and responsibility Project Management: August 2005 Page 10

11 Start-up This best practice guideline covers the requirements during the actual project start-up process. Ensure that all key stakeholders and team members attend a start-up meeting so that consistent information is communicated about the project. If necessary, conduct a series of meetings Take the opportunity to use the start-up meeting to include initial training for the project, if required, and provide supporting documentation to all attendees Encourage a positive and open team culture by recognition of team roles and contributions Recommended Activities a. Schedule the start-up meting to allow all team members to attend b. Design an agenda that is relevant to all attendees. The agenda should include: the project plan expectations for the project with respect to scope, timings, budget and quality standards roles and responsibilities change request process detail the procedural requirements for the project (i.e., standard and project-specific SOPs, monitoring guidelines, investigational medicinal product [IMP] management plan, as appropriate) training on any project-specific requirements c. Document the findings of the meeting and provide minutes to all attendees d. Ensure that anyone who was unable to attend the project start-up meeting is fully briefed on the project requirements and that this is documented Study Management These best practice guidelines cover the longest period of the project from its initiation to completion. Project Management Select and utilise project management tools based on the principle that information-based decisions need to be made quickly during the study Recommended Activities a. Update project management tracking documentation on a regular basis b. Utilise the information on the project management tracking documentation to determine if variance from the project plan is evident c. Implement appropriate contingency plans if variance from the project plan is occurring or is likely to occur d. Communicate any variance from the project plan to key stakeholders e. Review the individual risks in the risk log; reassess the risk probability and refine contingency plans as necessary. Add in new risks as they become apparent and remove any risks that have been mitigated Project Management: August 2005 Page 11

12 Status Reports Review the project as each milestone is reached and produce a report for that stage for all relevant parties Recommended activities a. Provide status reports during the various stages of the project to stakeholders and project team members at the agreed frequency b. Ensure that all relevant people are given the information they need in a timely manner Team Management The Project Manager should ensure that all individuals have a clear understanding of their own responsibilities or accountabilities. The training needs of the team should be reviewed on an ongoing basis with line managers Review how long team members are spending on project activities; understand the impact of other projects on the allocation of resources; manage staff turnover Communicate openly and honestly with both good and bad information. Ensure sufficient time for communication and ensure agreement is gained for any subsequent changes to plan Address any conflict that arises within the project team at the earliest opportunity Recommended Activities a. Ensure project team members are aware of their responsibilities and are working within the scope of the project plan b. Review task time and ensure appropriate number of team members are allocated to the project c. Maintain open channels of communication with all team members d. Review training needs of team members on an ongoing basis and conduct training activities, as appropriate Completion This best practice guideline covers the requirements for suitable closure and evaluation of the project on its completion. Ensure there is agreement with the sponsor on the outcome of the project Evaluate the performance of the project team and disseminate this information to the team and appropriate management Adequately handover the project, any documentation and supplies to the project sponsor Recommended Activities a. Communicate with the sponsor to agree project endpoints have been reached b. Evaluate and document the achievements of the project team and any knowledge gained from the project Project Management: August 2005 Page 12

13 c. Acknowledge project team and team members performance, as appropriate d. Ensure all project documentation is complete and filed appropriately and is transferred to the project sponsor e. Ensure project files are archived in accordance with sponsor and company requirements f. Hold a close-out meeting to capture learning and recognise possible improvements for future projects. Define what went well and what might have been done differently Project Management: August 2005 Page 13

14 Definition of Terms Budget A cost budget is obtained by applying an estimate of resources to the projected activities and tasks. Clinical Development Plan A document that includes all of the activities pertaining to the development of a new chemical entity (NCE); it includes commercial and regulatory strategies, project plans, overall budget, resource forecast, and study and operational feasibility. Contingency Additional time or budget identified as a possible requirement, if the project does not progress according to plan. Deliverables A document or verifiable outcome at the end of each stage of the project, including the final product. Feasibility The extent to which a project may be done practically and successfully. Gantt Chart A graphical method of showing a project plan which illustrates project time, dates, all activities, resources and their relationships. Milestone A significant event in a project usually linked to the completion of a deliverable, or to the achievement of something important. Pass-through costs Costs for travel, investigator fees, vendor fees, etc., which are passed through to the sponsor at agreed intervals during the project. Project Plan The documented activities and timelines as agreed by the project stakeholders. The Project Plan is part of the clinical development plan. Project Management: August2005 Page 14

15 Project Sponsor The project sponsor is the person with formal authority who is ultimately responsible for the project. Resource Anything other than time that is needed to carry out a task. Risk Analysis Analysis of the probabilities and consequences of certain undesirable events occurring and their impact on attaining the objectives. Risk Management Identifying, analysing and responding to risk factors throughout the life of a project and in the best interest of its objectives. Sponsor [ICH GCP 1.53] An individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of a clinical trial. Stakeholder A person on whom the project will have a major impact, either as a customer or as a resource provider. For example: representatives from data management, pharmacovigilance, quality assurance and study supplies. Start-up meeting Meeting of the project team at the start of the project to ensure that the roles are clear and the scope of the project is agreed and understood. Project Management: August 2005 Page 15

16 Abbreviations CPD Continuing professional development CRO Contract research organisation ICR IMP NCE SOP Institute of Clinical Research Investigational medicinal product New chemical entity Standard operating procedures Project Management: August 2005 Page 16

17 Bibliography 1. ICR Continuing Professional Development Scheme 2. ICH E6 Guideline for Good Clinical Practice 3. Operational Standard for Professional Practice; Introductory Booklet 4. Operational Standard for Professional Practice; Study Start-up 5. Operational Standard for Professional Practice; Recruitment & Monitoring 6. Operational Standard for Professional Practice; Study Close-out 7. Handbook for Project Management Procedures, Albert Hamilton, Thomas Telford Publishing, Managing Projects, Building & Leading the Team, Boddy David, Prentice Hall, Project management, Lock, D, Gower, Project management of drug development, Bryan C Hurst and Gill Pearce in Principles of Clinical Research ed. Ignazio Di Giovanna and Gareth Hayes, Wrightson Biomedical Publishing Ltd, Project Management Institute (PMI) Standard and Body of Knowledge Risk and Decision Analysis in Projects, J Schuyler, PMI, Decision Analysis for Management Judgement, P Goodwin and G Wright,) Wiley, Project Risk management, Processes, Techniques and Insights, Chapman C and Ward S, Wiley, Strategic Project Management, T Grundy and L Brown, Thomson Learning, Handbook of Project management and Procedures, Hamilton Albert, Thomas Telford, 2004 Project Management: August 2005 Page 17