How to plan a Clinical Data Management setup for EDC

August 30, 2018
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How to plan a Clinical Data Management setup for Electronic Data Capture (EDC) - The white paper is out now.

When it comes to setting up forms and questionnaires for EDC, we’ve noticed a trend. Most, are keen to get their study started but had not considered what it takes to set up a study.  The time from set up, to study start prolongs due to lack of planning, which affects the overall project plan.

Lack of planning, testing, and requirements specification can cause problems. Problems such as miscommunication, missing data, and delays. Therefore, efficiently setting up a study resolves the problems. Meaning the study is set up with minimal delay.  And the key to an efficient setup is to design a specific data management plan or study setup plan.

If done correctly, data collection is initiated on time. And you’ll be able to collect the data required, without being a burden on existing workflows.

The following sections are a sneak peek into the white paper.

Mise En Place

Mise en place is a French culinary phrase which means “putting in place” or “everything in its place”. This phrase and its mentality are applicable to data management as well. Quality data collection begins quicker the more requirements prepared before setup.

Start with Roles  

All studies include groups of diverse people, with different expertise and experience. Most are usually clinical professionals. But there are many roles that come into play at different phases of a study, e.g those who handle the data management.

A few roles to consider for your data management plan

  • Who is responsible for setting up the data management solution? If many, who should be responsible for what area of the setup? Forms, process, questions, etc.
  • Who should be responsible for translating?
  • Who should be involved in testing the setup? An external tester is highly recommended.

Once you have considered roles you can move on to the main ingredients.

Prepare the "main ingredients"

All studies have one thing in common: one or more endpoints. To drive a successful study you will have to define a hypothesis. These endpoints will depict if the hypothesis is true, or false. One or more variables define the endpoints. Collect variables through forms and questionnaires. The next thing before setting up your EDC solution is to prepare your main ingredients. That is, define the variables and the context in which to collect.

Furthermore, a few steps to follow that help specify the variables and forms or questionnaires you need.

  • Define the answer possibilities for your questions. This will simplify input and return more quantifiable data. Free text, for the most part, is not ideal, because it requires cleaning, and can increase the risk of erroneous input. Read our white paper on How to design an eCRF

What are the main ingredients?

The white paper goes into depth about each ingredient. Below is an example of one of the ingredients.

The Data Entry Role

Who handles capturing data?

The usual answer would be study personnel. But, data capture  happens via computers, tablets, or smart-phones. So consider if the solution allows for data capture from subjects.

A good example, is subject specific questionnaires. Which are often designed to capture patient-reported outcomes, or clinical outcome assessments. Check if you want to provide subjects the option to complete questionnaires at home.

We’ve seen results from projects that have utilized such features. And, subject compliance has risen from below 50% to above 80%.

This requires questionnaires to be well designed.  To avoid subject confusion and misunderstandings. Thorough testing can resolve these problems.

Data Management Plan - A checklist ✔️

We have generated a checklist to help you plan. Ask those involved the right questions to streamline and structure the planning process.

We are aware that not all the items listed above are applicable to every study. But, can rather serve as a general guideline. Below mentioned are a few points from the checklist.

  • Define roles and tasks for the whole data management plan.
  • Specify the timing for subject questionnaires, reminders, and possible time limits for completing questionnaires.
  • Define who should capture what data.
  • Be critical of what data to collect. Revise with healthcare professionals more than once.

Design a setup plan it will allow the entire process to run smoother and save time, money, and frustrations.

Get your copy

This white paper is for both veterans and first-time users of data collection tools. Download your copy and get access to all the "ingredients" and the checklist to help you plan your setup.

Get My Copy

You can also find more SMART-TRIAL publications here