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What Do We Do Next? Your Site's Quality Management Plan

Learn how to make better decisions for your business from this successful site owner's personal Quality Management Plan. Best practice downloadable worksheets available!


Business Development

As owners, directors, or managers of small sites, how do we make decisions? When I was first starting my clinical research site 8 years ago I would immediately say yes to everything and figure out the logistics later. I was grasping and clawing at any opportunity that presented itself. Often, in hindsight, accepting some of those opportunities ended up not being the best decision as they were incredibly costly, not efficient, or poorly planned. Frequently they were time consuming and most have now faded into a distant memory that was the evolution of my company.

I return to this question: How do we make decisions? I started looking into some best practices recently when, yet another costly, inefficient process was started and then abandoned at my site. The kicker was that the idea was solid and I still want to implement it. The problem was that, at this time, I have neither the time nor the resources I need to implement it properly.

So, to the sidelines it went… again.

I decided I needed to come up with a systematic way for deciding what business processes to tackle first to enhance quality, innovate, and stay relevant as a small site.

To make decisions that will positively impact my clinical research site's business development, I developed a Quality Management Plan. This is a simple plan to start at your own research site to ensure a level of continual excellence by implementing and measuring key systems that will produce quality output. It has been helping me DECIDE what initiatives and programs I want to implement first, how to implement them, and how to assess the success of these programs. This plan has systematized my decision making so that I am no longer grasping and clawing at opportunities that may not be a good fit for my site.


A Quality Management plan is built on 7 Key Principles

  1. Customer Focus

    We must, as sites, retain the confidence of our customers, both the subjects in our studies and the sponsors paying us to conduct the trial at our site, by ensuring our interactions with them create a positive experience. We must exceed both of their expectations.

  2. Leadership

    Engaging our staff and aligning the strategies, policies, and processes of our site is key to being laser focused on our mission.

  3. Staff Engagement

    We must empower, recognize, and enhance the competencies of our staff to achieve the level of excellence we strive for at our site.

  4. Process Approach

    We must understand our research site's processes and the steps we take to implement them in order to efficiently manage activities. This understanding will allow us to optimize the system and its performance.

  5. Improvement

    To stay relevant, all businesses need to continually maintain high levels of performance and adapt to both internal and external conditions.

  6. Evidence Based Decision Making

    This step is where we often fall short. As much as possible, we need to base decisions off as many facts and evidence we can collect. If we jump into a decision without looking at all of the information, our decisions are unlikely to produce the desired effect.

  7. Relationship Management

    The stakeholders in any decision have a large influence in the performance of an organization. If we can manage the relationships with these stakeholders, sustained success is more likely to be achieved.

How do you implement these steps at your research site to grow your research business? I designed three worksheets that I fill out when thinking about implementing or changing a policy, purchasing new software, changing vendors, etc. I use two of them prior to implementation and a third after we have tried it out.

The first worksheet is all about Plan Development and starts by stating the purpose of the plan. After that, it's a multitude of questions about the plan such as:

The next worksheet is titled Metrics Development and has only three questions on it:

I try to pick 1-3 metrics to measure. This will allow me to really get data on whether the new system or process is working.

I use the third worksheet after we've implemented the new process or plan. It is designed to Evaluate if the plan worked. It has questions such as:

Download the Plan Development Worksheet, Metrics Development Worksheet, Evaluate Worksheet


Putting it all together

The key to any successful Quality Management Plan is a four-step process:

  1. Plan

    This is the plan development worksheet and the metrics development worksheet.

  2. Do

    Implement the plan by having a project kick-off or announcing during a staff meeting.

  3. Check

    This is the third worksheet where you evaluate what went well and what needs to be improved upon.

  4. Act

    If, based on the prior step, it looks like the plan was a success then act and move forward. If not, revisit the plan and repeat the process.

I think Stephen Covey puts it best in his book The 7 Habits of Highly Effective People,

"'Begin with the end in mind' is phrase based on the principle that all things are created twice. There is first a mental or first creation, and then a physical or second creation, to all things."

If you take the time to carefully think through your process you will succeed in making decisions that are efficient, effective and have long-term success.

Jill Heinz, author

Editor: Jill Heinz is the Owner and Director of Injury Care Research - a site full of super-coordinators! Jill has worked in the research industry for over 17 years and is a Certified Research Coordinator and Certified Research Contracts Professional. Her favorite task is meeting with research subjects and overseeing the coordination of clinical trials.

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