Should EDC applications should contain completion instructions and/or help texts associated with individual fields or eCRFs?
Some believe that if the questions are worded clearly, the cursor control is logical and helpful, the layout is clear and uncluttered, and appropriate data capture structures are used (e.g., radio buttons, dropdown lists), then there should be no need
for additional instructions or help as the form should stand on its own. To address differences between sponsors in layout, cursor control and question wording, a study conventions document can be prepared that contains general information regarding entering data and the like.I believe that this is only part of the picture. Without question, EDC prompts should be very clear, use appropriate field structure, and so forth. These characteristics are tightly linked to defining and capturing high quality data. It is also not necessary to create help texts that only restate the prompts, e.g., a help text of “Please enter the subject’s weight” on a field with the prompt “Weight.” Finally, a study conventions document can provide valuable information about navigation, handling individual fields with missing data (e.g., put a note in the pop-up query window), and the like.
On the other hand, such a document does not educate the sites with respect to many of the sponsor’s other expectations for data quality and consistency, which can be thought of as the scientific or business rules, and this can be quite a thorny issue. For example, the study conventions document does not provide specific information on the edit check ranges used on the fields, nor why those ranges were chosen. It doesn’t usually alert the site to data relationships the sponsor expects to see, such as AEs corresponding to each new concomitant therapy started during the study. In fact, virtually everything that the sponsor expects check and that could result in a query should be communicated to the site in some way. Otherwise, how is the site supposed to know how the data should be captured and recorded? It is like requiring them to take a test on material that they have never been taught!
Some of the information mentioned above could be drawn from the protocol, but many protocols do not go to this level of detail, and given that study coordinators often run many studies with different sets of rules, it would seem safer to add the rules to the tool they use to prompt them for those data. The information is also in the Data Management Plan, but most sites do not see that. Given the amount of disagreement there is on chat forums such as LinkedIn, it is clear that there is no consensus on many of these practices, so how can we expect the sites to “just know” what to do? Here are some more examples of scientific or business rules that I have seen vary either on discussion forums or between clients:
- When in a study to start capturing AEs and SAEs?
- How far from the protocol-defined visit day can a visit occur and still be “compliant”?
- Over how many days can a visit occur and still be “compliant”? E.g., bloods one day, physical exam the next, ECG the following.
- How should open AEs and concomitant therapies be handled if the subject dies during the study (i.e., should they be closed out with date of death as the end date, or left open)?
- What conditions should be recorded on the medical history screen? I.e., starting at what time point, or “clinically significant” ones only (though that definition is not always clear)?
- Should symptoms or diagnoses be recorded on AE eCRFs?
