Experience is essential – this also applies to the art of designing CRFs for a clinical trial. A Case Report Form, or CRF for short, is used to record examination data collected following the protocol of a clinical trial. Depending on the research question of the trial, a CRF must be carefully tailored to fit the required subjects’ data and its subsequent evaluation. This is why the design process requires such a high level of preplanning and foresight as well as the ability to engage in dialogue and mediation between the different parties involved in the process.

When planning and designing CRFs, a great attention to detail is crucial. What should a CRF designer be aware of?

The CRF designer should be involved in the protocol development from the very beginning and should be given enough time to study the protocol. It is crucial to implement the measures described in the protocol with the utmost precision in the CRF. In practice, this is often more difficult than you might imagine.

The important point is to precisely specify the CRF requirements in the protocol. The CRF designer needs to specify exactly which examination must be performed at what time and in what order. This is always a tightrope walk, giving the physician a certain amount of freedom while at the same time taking all steps into account.

Therefore, the CRF design must be as clear as possible:

What does the protocol provide, what does the study team want, and how must all this then be considered in the CRF? The CRF designer must think about future use. For example, if certain items are built into the CRF in an unfortunate location, they may be overlooked during data entry so that some pages are simply forgotten and not filled in. The CRF designer should therefore adapt the layout to the logical progression of the examinations. This makes it easier for study personnel to enter the results.

CRF standardisation is a topic that inevitably comes up when talking about CRF design. What are your experiences in daily practice?

Standardisation is another point to consider. Certain questions should always be included, which of course simplifies the process; but it is also prone to errors. If the same questions are always raised, pooling works better. The point is that on the one hand, especially for new projects, there is often no standard. The CRF designer then has to take the previous CRFs and protocols into account for subsequent studies to ensure that the same question is asked. On the other hand, there is also a learning process; one finds out that a question was not asked well or correctly in a previous study. This has to be changed, although the later pooling of data will then be more difficult: As helpful as standards are, they must also be further developed and sometimes adapted for specific projects. The CRF designer must make sure that the questions are the same, otherwise the data cannot be used.

An example that might make things clearer is the question about a patch that is used in a clinical trial. The question “How much of the patch remains on the skin?” is fundamentally different from the question “How much of the patch is detached from the skin?” The result would be different, the data could not be evaluated. For this reason, it is so important to ask the right questions at the design stage.

Does the principal investigator also have influence on the course of a study?

Yes. The principal investigator may receive the protocol from the sponsor for review and concludes that the course of the investigations, as scheduled by the current protocol, is simply not feasible. This may be due to purely medical or organisational reasons. The protocol then must be adapted.

The physician must also pay attention to the sequence of the examination at all times, ensuring that it fits in with the logistics at the site, that the patient’s well-being is not endangered and that the measurement results are reliable.

What constitutes a good trial team?

High-quality CRFs are always a team effort.
It is always beneficial if the study team works very well together and you have some experienced members in each team. Experience helps a lot in planning and conducting studies. Detailed questions concerning statistics or data management in particular require a lot of background knowledge from the entire team so that they can be taken into account when planning studies. These two areas are particularly important in the protocol preparation and thus later in the CRF design so that the data can be recorded properly.

About Claudia Loosen:

Claudia is responsible for the development of EDC products at Healex. Claudia has more than 20 years of experience in the field of clinical trials and knows the challenges of documenting and working with clinical data.

About Healex:

Connecting and accelerating medical research and treatment – with this goal Healex develops solutions that support and fasten clinical work and networked research, especially in the current Corona crisis.

Healex enables the transfer of information from various clinical and research systems as well as secure and usable storage of health information. The data can be used for prevention, up-to-date anamnesis, care, and science.
This enables fast, cross-site clinical trials and real-time data exchange between clinical research and care.