Successful businesses have project plans and project managers to carry out those plans. To find success at a research site, institutional staff need a plan for each protocol and a designated manager ensure tasks are carried out accurately and in a timely manner.
Beyond just setting timelines, a project plan should include the following components:
- Clear objective: State the goal or desired outcome.
- Set timelines: Envision the length of the project, projected study startup timeframe, and deadlines for items such as IRB reviews, enrollment activities, etc.
- Defined resources: Consider who or what is needed to complete the protocol, and if staff has access to those resources.
- Staff accountability: Determine who is held responsible for each task.
- Communication details: Outline what needs to be communicated to the team, including how it will be done and who will do it.
- Associated risks: Understand the risks associated with conducting the protocol and how they will be mitigated if problems arise.
After completing an effective project plan, it is time to look at the process to complete the project or protocol. Clinical trial project management can be broken down into a five-step process:
In this phase, consider pre-trial activities: tasks leading to acquiring trials such as business development, feasibility analysis, and general patient recruitment to build a database.
With the protocol in hand, the planning phase begins. Use the components listed above to determine who is responsible for which activities and within what time frame.
The third phase is the actual execution of the protocol: scheduling patient visits, submitting case report forms (CRFs), processing payments, etc.
The monitoring phase applies to both internal monitoring of protocol activities and as part of the regular monitoring from the sponsor or contract research organization (CRO). Internal monitoring at the site is particularly useful in uncovering gaps or inefficiencies, which may require an initial project plan to be re-assessed. Catching these early helps reduce any roadblocks later.
The last phase is to analyze the results, which can go hand in hand with the monitoring phase. Running reports regularly throughout the protocol lifecycle will provide sites with insight into the success of the study. Upon study completion, teams should also reflect on how the project went, particularly noting if the project was completed well, on time, and anticipated improvements for the next protocol.
Project planning is an art, and when done well, leads to successful clinical trials and an increased sense of unity among staff. A key part of project planning is to include the right mix of people and processes, ensuring smooth communication between all parties. Before beginning another study, make sure to have a project plan in place coving the entire scope of the protocol.
- Farrell, Barbara et al. Managing Clinical Trials. http://www.trialsjournal.com/content/11/1/78
Editor’s note: This article was originally published on September 23, 2013.
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