Reporting in nowEDC

What is reporting in nowEDC?

Reporting is a dedicated module within nowEDC primarily used by Clinical Data Managers (CDM’s) in order to create detailed reports of particular data sets and reports that show up to date page statuses. Reports can be ran by nowEDC users to ensure that the study, in general, is moving along according to its timeline. It is easy to navigate and quick to run and reports can be setup to reoccur automatically which frees up time spent to do other things. The nowEDC reporting tool can produce reports to visualise data sets and status data in different ways e.g. bar charts, scatter graphs to represent and identify trends, correlation etc.

Why is it needed?

Researchers have good reason to be vigilant of the progress of their studies, often working to budgets and timelines that are difficult to adhere to. Problems must be quickly addressed, and delays minimized. Study timelines can be a source of anxiety for researchers, which is why time-saving innovations in nowEDC, such as reporting, are valued. Clinical data collected in Electronic Data Capture (EDC) software goes through a cycle of being checked, vetted, validated and cleansed as part of the processes of examining data in a clinical trial, it is important to be able to pull together information that can be easily read and researched in a report.

How does it help the user?

Being able to report on any aspect of the data collected in an easy, intuitive way is a key requirement for time-saving, for example, scheduling regular reports to be used as investigative – to spot any early signs or indicators of what is happening within the trial at any given time. Outstanding queries, page completion, whether source data verification has been performed, adverse events recorded and other data can all be viewed in reports generated by the software in real time, whenever they are required.

nowEDC reports enable researchers, whether in a high-level overview or a detailed display, to see where delays are originating and thus address those delays in a timely and targeted fashion. These reports are a major component of efforts to facilitate time savings and efficiencies in all phases of a clinical trial.

How is having the reporting tool an advantage?

An EDC system often has a multitude of Electronic Case Report Forms (eCRF’s) for both patients and researchers to fill out, each with completion and collection due dates. When a due date is missed, a study can suffer delays – especially when busy researchers with large workloads miss the fact that a form is overdue until weeks or months have passed. Without this information, missed due dates can go under the radar, and study timelines can lag as a result. In the Reporting module in nowEDC, users can run a report showing open queries and how long they’ve been open, as well as closed queries and how long it took to close them. These reports can be filtered by site so that sponsors and CROs can determine which sites are resolving queries, and which require support. This is one example of how the software can save time and identify any potential disruptive actions.

Another advantage is the fact that reports can be easier to read than using a data extract, and can be set up to be pre-filtered and sorted also saving time and getting the specific information that a user requires quickly and simply. They are also repeatable, meaning that comparison between reports can be easier to set up.