Primer on Clinical Trial Data Validation Process, Part 2

In part one of this two-part blog series, we went over some of the basics on the clinical data validation process during research studies. Vital for ensuring correctness and integrity of any data produced during a medical trial, data validation, also known as process validation, is carried out in some manner for virtually all clinical studies in any field.

At AGA Clinical Trials, we’ll be happy to detail our clinical validation processes for any of our medical research studies, which span from those researching specific conditions to healthy volunteer needs and more. Part one mostly dug into what the validation process refers to and why it’s important – today’s part two will delve into the specific steps for how validation is done within a trial.

clinical trial data validation process

Planning Stage

One note as we get started here: Data validation is a complex process that will vary between studies based on the data being studied, the business type, regulatory concerns and other factors. The steps we’ll outline here will be a broad primer – beware that there are many variations herein.

The first stage, no matter what sort or scope of study is being done, is the planning stage. This is the stage during which the trial’s sponsor checks into the sorts of materials required, the code lists that will be needed, and what kinds of procedures will be in place in case of any invalid results. In addition, all such checks, lists and procedures will be carefully documented during this stage so there is no confusion later.

Implementation and Testing Stage

During the next stage, the checks and code lists that were organized during planning will be implemented into the clinical database management system being used. There are several such systems that may be utilized in the field.

From here, test procedures and result data are created as part of database validation. Then, tests are performed to validate the data.

Data Entry and Validation Stage

During data entry, the checks that have been set up will run. This will be done either as the data is entered in live time, or at various planned intervals.

If invalid results are found, they can be fixed using the procedures already decided upon. Then there will be a final set of checks, usually called “data cleaning.”

Database Lock Stage

Finally, when there are no further updates or changes to the data expected during the trial, the database will be locked. Analysts do still have access to it, and can run additional checks to note necessary changes based on required analysis, but the primary validation process is finished.

For more on clinical trial data validation, or to learn about any of our clinical research studies, speak to the staff at AGA Clinical Trials today.