Place fields that routinely appear on multiple forms at the top of the form. For example, if the collection date and time are both asked, they should appear first and second, respectively, on each form where they are used.
2
Fields should be placed on the form in the order that they are expected to be collected
during the clinical assessment
. It is acceptable to include fields from different domains on the same form if consistent with the
clinical
data flow.
3
Group related fields for a single clinical encounter together, although multiple time points or visits may appear together on one form. For example, if heart rate and temperature are taken every hour for 4 hours on study day 1, the form can collect the data for hour 1 (e.g., heart rate result and unit, temperature result and unit), followed by the data for hour 2, hour 3, and hour 4. In this scenario, there would be labels indicating each time point within study day 1.
4
Group related fields together. Test results and their associated units should always appear next to each other. For example, the results of “TEMP” should be followed by its allowable units of “F” and "C".
In some cases, the result might have only 1 applicable unit. For example, the only applicable unit for "PULSE" is "beats/min". The unit should be displayed on the CRF and database.
5
Data fields that are dependent on other data fields should be placed in the CRF in such a way that this dependence is obvious. For example, if there is a question in a paper CRF where “Other, specify” is an option, the the text box used to collect what is being specified should be placed in proximity to the “Other” question to indicate that it is a subpart of the “Other” question.Example: An EDC system that requires a specific response in order to render 1 or more additional, related questions.
6
Lists of values that have a logical order should be provided on the CRF in that logical order. For example, the values of “Low”, “Medium”, and “High” are logically placed in this order. Do not list “Medium” first, “Low” second, and “High” third.