As a Clinical Project Manager (CPM), one of my primary roles on a project is to ensure that the clinical and data management stakeholders have the tools necessary to streamline safety review and data quality review on a project. The CPM’s first action should be to complete a Stakeholder Analysis. According to the Project Management Body of Knowledge (PMBOK), Fifth Edition, released by the Project Management Institute (PMI), the key processes in Stakeholder Management are:
1. Identify Stakeholders
2. Plan Stakeholder Management
3. Manage Stakeholder Engagement
4. Control Stakeholder Engagement
Knowing who the stakeholders are, and how and when to engage them in the development process of a clinical application, can lead to major improvements in product usability and ultimate project success.
Let us use a medical imaging data capture module as a case study for this exercise.
Step 1: Identify Stakeholders
When approaching stakeholder identification for any technical tool, it can be helpful to group stakeholders into three groups –
(1) who is the user that inputs the data into the system
(2) who reviews the data that is entered within the system
(3) who analyzes and/or cleans the data entered into the system
For medical imaging modules in clinical trials, in general, site data managers or coordinators enter the data, medical monitors or data adjudicators review the data, and data managers (DMs) or clinical research associates (CRAs) query and clean the data to ensure data quality. Depending on the project, biostaticians may also be stakeholders in this process.
Once you identify the project stakeholders, it is important to determine their roles and responsibilities and incorporate these into a Stakeholder Register for the project. Click here to see an example Stakeholder Register for a medical imaging development project.
Step 2: Plan Stakeholder Management
Once you have identified the project stakeholders and developed the Stakeholder Register, there should be a clear understanding of what the stakeholder requirements and responsibilities are for implementation and use of the imaging module. It cannot be stressed enough, how crucial this planning step is and how much time it can save you in the end, if done correctly. After the stakeholder identification step, the CPM must determine the appropriate level of engagement for each stakeholder. Some relevant questions may be: Is the stakeholder interested in being included in the requirement gathering and development of the system? What is the stakeholders influence on the overall project satisfaction? How should the stakeholder be managed? What is the best communication method with each stakeholder? It is important to have deeper conversations with the stakeholders in each relevant functional area. For our example, some questions to jump start these conversations with each group could include:
Data Enterers (Sites Staff)
- Are all of the images collected at your site DIACOM images?
- What modalities are you expecting to collect for the trial (i.e. CT, MRI, etc.)?
- Does your site have a process for removing personal health information (PHI) prior to submitting images to a central imaging database?
- Who will be uploading the images for your site?
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Are there any institutional processes related to submitting images to a central database?
Data Cleaners (Data Managers, Clinical Research Associates, etc.)
- What is the query process look like on the project? If it is a medical query, will the medical reviewers query the site or will these be conveyed through the DM or CRA?
- Is there a need for a QC step to ensure that basic quality checks of the data entered by the site are met (e.g. no PHI; the correct modality was used; the correct body part is displaying in the image)?
Data Reviewers (Medical Monitors, Adjudicators, etc.)
- Are specific protocol requirements regarding the image frequency, type or modality that should be considered when configuring the system?
- Are there any DIACOM tags that would ease your review if they were displayed as labels?
- Are there specific images that are critical for comparison (e.g. baseline to last scan)?
- Are there data in the EDC system eCRFs that, if pulled into the imaging module, would ease your review?
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Are there any imaging analytical tools that would be of use (e.g. measuring tools, image markers)?
The CPM will need to determine if any stakeholder can provide subject matter expertise in the requirement-gathering process. If it is an option, it is always a great idea to see demonstrations of the imaging module at checkpoints throughout development Stakeholders should be involved in these reviews, whenever possible. By creating acceptance checkpoints and including stakeholders in the end-to-end process, the risk of discontent with the product decreases substantially.
Step 3: Manage Stakeholder Engagement
In addition to involving stakeholders in the process and holding subject matter experts accountable for providing guidance, the CPM should also think of ways to build in support for stakeholders. For medical imaging modules, this could mean creating user guides and manuals or providing interactive training sessions. There should also be a well-documented process for how users can get technical help or assistance if troubles arise.
Step 4: Control Stakeholder Engagement
Controlling stakeholder engagement is a continuing process throughout the lifetime of a project. For a medical imaging module this could include:
- Utilizing the reporting tools within the system to confirm that tasks are on target for timely completion. If tasks are identified as at risk, CPMs should proactively reach out to stakeholders to discuss mitigation.
- Updating the user manuals and guidance documents to include lessons learned as project progresses.
- Working with stakeholders during protocol amendments to perform an impact assessment on the medical imaging module.
- Ensuring that CRAs are working with site coordinators to provide training resources that will allow site staff to perform their job functions efficiently.
Our example was the development of a medical imaging module but, as you can see, from the principles and steps can apply to the development of any other system or application for a clinical research trial. Engaging stakeholders early and understanding end-user requirements will improve the odds of deploying an effective tool for any project.