Frequently Asked Questions
Here are some frequently asked questions about our eClinical trial forms processing system. Hopefully these will answer most of your questions but if you have any more complex questions or require further information, please don't hesitate to contact us.
How soon do we need to get you involved?
As early as possible in the development of the clinical trial and Standard Operating Procedures. Our experience and advice at the beginning not only speeds up the setup but also reduces the chance of having to change your forms a number of months down the line. It is important to get it right first time by anticipating any issues or stumbling blocks.
Can you advise on form design?
The aim is to ensure data is routinely recorded and readily available. Towards this end, UKTMN recommend that you make the form attractive and as easy as possible to complete. We suggest the development of a trial logo, vibrant colours and simple tick boxes to make the form as 'forgiving' as possible. Constrained print boxes can be used to capture handwriting with open ended text boxes only used where the data being captured will be genuinely useful to the trial. The aim is to minimise free text fields to make the data more accurate and measurable. Clear writing and directions along with good layout will reduce the likelihood of errors and extra administration later on.
Is the system 21 CFR Part 11 compliant?
Whilst it is impossible to guarantee a software component of a much larger clinical trial system is 21 CFR Part 11 compliant out of the box, it is certainly possible to use eClinical and TeleForm as part of a compliant system. Certain responsibilities of compliance rest upon the end user of the solution to implement robust and compliant procedures and methods. ePC can advise and ensure the end solution is compliant. Cardiff have produced a white paper that gives guidance on the point-by-point compliance issues. Please download the white paper here.
Will we need to change our existing forms to work with eClinical?
Our system works best with forms designed for automated data capture. Features such as corner stones are used to help the system orientate the form properly. A barcode or form number is used so that the system can identify the form type and fields such as constrained print boxes aid swift recognition.
However, eClinical does include an existing form templating system, to allow your existing forms to be captured. This is useful if the forms are supplied by a client or you already have a large investment in pre-printed stationery that can not be changed, for example.