How to take advantage of an Electronic CRF without giving up the paper CRF benefits?
Let's start with the undeniable advantages of an electronic CRF:
1. When data is deleted / modified, the audit trail keeps track of every single change
2. Data is constantly checked thanks to hundreds custom auto-checks that are programmed to match the protocol requirements. It drastically improves data quality and data accuracy: data formats, range values, time frame, inconsistencies, missing data... everything is checked upon data entry and the user is prompted to correct data.
3. Questionnaires scorings, BMI, age, reminders on the dosing to give at each week, planned dates for visits to come, etc.... are calculated automatically
4. The server has the highest security standards and it is backed-up every day
5. Email notifications are automatically sent to the relevant recipients in case of SAE. Also, a notification can be sent to the pharmacist to remind him/her about a drug preparation with dosing specifications towards the patient's visit.
6. Data can be exported and formatted easily to initiate a statistical analysis.
Now why sites still have difficulties with data entry on the EDC?
1. Because each EDC system has its own features, either regarding the graphic design, lexicon, query handling, monitoring or data processing . When a new study is done on a new EDC system, the study staff must practice again in order to be fully comfortable with the new platform.
2. But the most frustrating point is that... most EDC systems can't offer an electronic CRF that looks like the paper CRF!
Some EDC systems can't provide tables and just place variables below each other. So instead of having a 10*5 table, you'll get 50 rows. Is it comfortable for the study coordinator? Think about blood tests: instead of having result/unit/clinical significance in columns for the same item, you will have them on 3 different rows. Isn't it confusing?
Sometimes the paper CRF has images (organ, full body) and the study coordinator must annotate it by circling the pain location, or the surgery location. Will the EDC give the possibility to display theses images and click on them to select a specific location?
At ClinXL we faithfully reproduce your paper CRF. How? We can digitalize ANY document you need in the EDC. Your EDC form is the exact replica of your paper form: we just add checkboxes, radio buttons or text areas on the form you provide (of course, in the system we also add the corresponding variable names, rules, edit checks and calculations). This way, it's extremely easy and comfortable for the study coordinator to enter data! It drastically reduces data entry errors and monitoring costs at the same time!
Example: the AE paper form you provided / the AE form in our EDC at ClinXL
You keep your paper-CRF habits and comfort on a secure, GCP-compliant, high-level and user-friendly EDC... and the whole study staff is happy :)