Successful businesses have project plans. They also have project managers to carry out those plans. To be a successful research site, you too should have a plan for each of your protocols and someone assigned to ensure that tasks are carried out accurately and in a timely manner.
Beyond just setting timelines, a project plan should include the following components:
- Clear Objective: What is the goal? Is there a desired outcome?
- Set Timelines: What is the length of the protocol? What is your projected study startup timeframe? What are your deadlines for items such as IRB reviews, enrollment activities, etc.?
- Defined Resources: Who or what is needed to complete the protocol? Do you have access to all the resources you need?
- Staff Accountability: Who will be held responsible for which tasks?
- Communication Details: What will need to be communicated to the team, how will this be done, and who will do it?
- Associated Risks: What are the risks associated with conducting the protocol? How will these risks be mitigated, should problems arise?
After completing an effective project plan, it is time to look at the process for completing that project, or protocol. Clinical trial project management can be broken down into a five-step process:
In this phase, consider pre-trial activities – tasks that lead up to acquiring trials such as business development, feasibility analysis and even general patient recruitment to build your database.
With the protocol in hand, the planning phase begins. This is where you will use the components listed above under project planning to determine who will be responsible for which activities and within what timeframe.
The third phase of the project is the actual execution of the protocol – scheduling patient visits, submitting CRFs, processing payments, etc.
The monitoring phase can be applied to both internal monitoring of protocol activities and as part of the regular monitoring from your sponsor/CRO. Internal monitoring at the site can be particularly useful in uncovering gaps or inefficiencies, which may require you to re-assess the initial project plan. Catching these early can help reduce any problems later on.
The last phase is to analyze your results, and can go hand in hand with the monitoring phase. Running reports regularly throughout the protocol lifecycle will provide you insight into the success of the study at your site. Upon study completion, you can also reflect on how the project went. What was completed well? Was it on time? What needs to be improved for the next protocol?
Project planning is an art that, when done well, can lead to successful clinical trials and an increased sense of unity among staff members. A key part of project planning is to include the right mix of people and processes, and ensure smooth communication between all parties involved. Before you begin your next study, make sure you have a project plan in place that covers 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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