Project management

Project management is the investment of time and effort to ensure the trial progresses smoothly and that the required resources are identified and allocated appropriately. Time spent on project management typically avoids confusion, delays and errors occurring later. Many dedicated tools and techniques are available to help organize project activities and conceptualize the steps required in order to meet the aims of the project on time and on budget.

  • Define the objectives and scope of the trial
    • What to achieve?
    • When & how to achieve the objectives
  • Develop the work breakdown structure (WBS)
    • List the main activities and then break down the work into smaller steps for planning and monitoring
  • Develop project network and timeline
    • Estimate the effort and duration required to complete each tasks.
    • Identify the relationships between activities to determine the order of tasks.
    • Develop a Gantt chart
  • Develop Resource plan
    • Develop a resource histogram to ensure enough working time for the staff to complete tasks
  • Identify initial estimate of costs for the trial
    • Estimates can be informed by comparing to previous trials
    • Consider the impact of the trial on the cashflow of the organization
    • Identify funding sources
  • Identify Stakeholders and plan communication with them
    • Understand the relationship of the stakeholders with the trial. Examples include the need to report to IRB, funders, clinical sites, regulatory bodies, DSMB, etc.
    • A communication plan may be required for larger trials (what information, what is the frequency, who is responsible)
  • Identify risks (internal & external risks) and plan to minimize or manage them
  • Develop a detailed and realistic budget

Once the trial begins it is essential to periodically review progress and update the management plans, budget etc.

Reviewing the project once complete can be useful to draw lessons for future trials. What went well? What could have been improved and how?

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