DATA PREPARATION

The way to success in close cooperation with the monitor.

 

A project must be a good match for us, the Camovis employees say full of conviction. If the intention behind it is right, it is all the easier to plunge into the work full of energy – even if time pressure and accuracy in the project literally demand full throttle. This was the case in a short-term project that the Camovis team had been put in contact with by a Clinical Research Organization.

“Data over data”, is how the content of the project can best be summarized. The physician responsible for the study in a cardiology department had changed clinics. During a visit to the monitor, it was discovered that the study files had not been maintained since then. Retrospectively and with a fast approaching deadline, all data had to be collected in order not to violate the protocol – and thus endanger the success of the study.

The subject of the study was a medical device implanted in patients with severe heart failure. The aim is to reduce the mortality rate and give patients a better quality of life. 22 people were included as patients in this study. After the preliminary study, the necessary data was collected over a period of four weeks; three, six, twelve and 24 months. Always with the questions: How have the parameters developed? Were there any unexpected events?

Two weeks of 40 hours each were designated to processing all the files, filter the relevant information and compile all the data. All study-specific paper files had to be filled in using the electronic hospital file. Then they had to reach for the Sharpie to black out doctors’ letters with patient data, which is extremely important for data protection reasons. Then it was time to go to the copy machine and finally to the filing system. A colleague of the CRA´s, who was actually responsible for the subject, had to take over a thorough introduction to the subject because the CRA was on holiday at the time.

It is not without pride that the Flying Study Nurse talks about her project today. She processed two and a half years’ worth of patient files within eight working days. This included: the complete data acquisition and, if necessary, “data correction”. All the information was prepared for the doctors in such a way that, ideally, all they had to do was sign the documents. The feedback from the physicians, who were more than happy that the Flying Study Nurse had looked beyond her own nose and taken on all tasks comprehensively, was consequently positive.

As challenging and exhausting as the effort for concentration and motivation was: The climate within the project was extremely good, the cooperation was literally “blind”. The CRO’s poaching attempt after the end of the joint project can certainly be seen as the biggest compliment at this point.

The employee remained loyal to Camovis. She knows about the freedom and scope that the company offers her – and that it lives the values it represents to the outside world inwardly. Just like in the selection of its projects. “Medical products are always very exciting as a project, because it is a product that makes sense. It can increase the quality of life of affected people by for example the device allowing them to walk their dog again. That makes us happy, if we can do our part.”