A case report form is defined in ICH GCP as a printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. It is the most import data collection instrument designed to collect the trial data to meet the protocol requirements. Success of a clinical trial depends on the quality of data collected; hence, it is very important to design a CRF which contains all relevant data points so that the data can be analyzed as per protocol hypothesis. Below are some considerations for an effective eCRF design:
1. Use of Dynamics: Some platforms like Inform, Rave and Datalabs give you the flexibility of using visit level, form level and item level dynamics. Using these dynamics can avoid many common errors done by the sites during data entry.
Dynamics: A visit or a form or an item can be dynamically triggered based on predefined conditions. For example, Visit 3 will appear only when Visit 2 is marked as complete or if a subject is marked as discontinued, a discontinuation visit will appear with some static forms. Pregnancy form can be triggered with item Gender on Demography form. If gender is entered is female, it will trigger the Pregnancy form.
2. Using Derivations: Derivations or calculation rules should be used where possible. This will avoid entry errors by the site. For example, a derivation can be written to calculate the BMI once the site enter Subject’s height and weight. Sequence numbers for Adverse Events/ Medical History or Concomitant Medications can also be put as a derived field to avoid site entering these manually. For some Oncology studies, BMI dependent Dose can be put as a derived field. Some platforms also give you the flexibility to derive the Date in DD-MMM-YYYY format.
3. Common Forms/ Add Entry Forms/ Repeating Visit: This may look strange; however, choice of each type of form/ visit should be carefully decided. A common form will appear at multiple visits in an unchanged condition. For example, Vital Signs form can be repeated at many visits if required per protocol. Add entry form will allow the site to record more than one observation for the same data. For example, AE form, MH form. Repeating visits can be added with selective forms more than once by the site. Unscheduled Visit is an example for of a repeating visit.
4. Choice of Radio Control, Pull Down/ Drop Drown and Multiple Choice boxes: Careful consideration should be given while deciding which question will appear with which control:
Radio Control: is used when there is only one option to be selected. This should be used when only fewer options are available.
- Gender: Male or Female
- Questions with Yes or No
Pull Down/ Drop Down List: is again used when there is only one option to be selected. This should be used when there are many options available. For example, Lab Units, medication route.
Multiple Choice Boxes: are used when there can be more than one answers for a question. For example, SAE criteria, Reason for early termination.
5. Sequencing CRFs and Questions: eCRFs and items within eCRFs should appear in the correct sequence. For example, Demography form should appear before Vital Signs eCRF. Similarly, BMI should come only after Height and Weight measurement.