When you design a CRF in OpenClinica, you can base it on an existing form you use (for example, a paper version), if you have one. But you will need to modify the form design so it works well in the OpenClinica web interface and takes advantage of OpenClinica’s features. Whether or not you have an existing form, you can benefit from these guidelines for designing the form before you create the defined CRF:
- List all the information (Items) you need to collect and record the parameters for each Item. For example, if you need to capture the Subjects temperature, the Item is Temperature, it is required, and the parameters are any number between 95.0 and 103.9, with up to one decimal place, in degrees Fahrenheit. You specify the range so that when a user enters data into the form, OpenClinica flags a value outside the acceptable range for further action.
- Determine if you will put all of the Items in one CRF or in multiple CRFs:
- If a portion of the CRF can be used for other Events or other Studies, you might want to define a CRF for just that portion so you can reuse it, and define a different CRF for the rest of the Items.
- If the information will be collected at different times during the Event, or at different physical locations (even within a Site), consider defining separate CRFs for each, or separate sections within the CRF for logistical convenience.
- Determine the sections in the CRF and what Items to put in each section. When you enter data into a CRF, you save one section at a time, so fewer Items in a section minimizes the risk you will lose data if you accidentally close a CRF without first saving it. Fewer Items in a section also means the page opens quicker, makes it easier to locate an Item, and minimizes the need to scroll.