How to define an eCRF?
The eCRF (electronic Case Report Form) is an electronic data capture (EDC) tool. It is used in clinical trials to collect information, replacing the traditional paper CRF. A well-designed eCRF is a prerequisite for any study, to ensure that it functions properly and complies with the protocol.
The aim of using an eCRF is to facilitate data capture and management in clinical trials. eCRFs enable real-time data entry and automatic validation of entered data, which can reduce data entry errors and delays in data collection. Finally, the use of an eCRF enables easier and faster access to data for statistical analyses and data reviews.
When designing an eCRF centers face 3 challenges:
- Forms creation in line with the defined protocol
- Accurate data collection
- Forms fluidity and clarity to ensure quality data entry
5 steps to follow when setting up an eCRF for your clinical study
01
Define study objectives and data to be collected
Setting up an eCRF requires the creation of a complete study protocol. This protocol includes extensive information on the data to be collected, the patients, eligibility and exclusion criteria, etc.
To comply with international standards, the data collected by the study center must be relevant to the study being carried out. By this, we mean the collection of data relevant to the study objective.
If more extensive data is collected, this may have an impact on the study by distorting the results. The notion of “sensitive data” should also be taken into account, as it defines the collection of information concerning sexual orientation, ethnicity or religion, etc. The collection of sensitive data requires the agreement of the regulatory authorities.
02
Designing the eCRF structure
Once the objectives of the study and the data to be collected have been defined, it’s time to design the eCRF.
When creating an eCRF, it is important to set up consistency checks and data validations to instantly check the responses. If they do not comply with the defined format or criteria, an error message is displayed.
Thanks to these checks, eCRFs enable you to facilitate data collection and ensure a high level of quality compared with paper CRF forms.
When creating the eCRF, it is also important to define data access. You can restrict access to certain parts of the eCRF.
In addition, the layout and flow of questions should be as clear and simplified as possible for investigators and any other users with input rights, such as clinical study technicians or monitors, who should not have any doubts or hesitations when collecting and checking data.
Here are a few rules to follow when creating eCRF questions:
- Do not use acronyms
- Avoid open-ended questions
- All critical data must be associated with mandatory fields
- Indicate units of measurement when entering figures
- Use logical conditions to avoid overloading forms
- Set up calculations for age, dates, and figures
- Use photos/sketches as instructions
03
Getting started
It is advisable to test the eCRF with the research team. The aim is to ensure that it is easy to use, that the questions are relevant, and that the data collected are effective, as well as to obtain opinions and suggestions for improvement. All users associated with the study, as well as the sponsor, have access rights (read, write, etc.) to the eCRF, depending on their role. All their actions are traced in the audit trail for complete traceability: data collection, inclusion, deletion, reason for change, eCRF queries…
A short training session can also be organized to familiarize all collaborators with the tool once the eCRF design is complete.
04
eCRF validation
Once you’ve got the hang of it, it’s up to the study sponsor or investigator to validate the eCRF. All they need to do is connect to the platform to check forms, data validation, exports, etc. Each parameter set is checked in test mode to limit potential modifications after the study has begun.
Once the eCRF has been validated, and all forms verified, the study can begin.
05
Patient data anonymization
In accordance with the CNIL, all personal data collected must not be divulged, in order to guarantee the privacy of sensitive data and the anonymity of volunteers. Patients must remain anonymous for the duration of the clinical study, thanks to anonymization or pseudonymization. A unique code such as CENTRE-0001 is used to identify each patient.
In cases where the data collected can be used to identify individuals, it is crucial to have HDS-certified hosting (Hébergement Données de Santé). Datacapt only offers HDS-certified hosting.
Datacapt eCRF
Datacapt eCRF meets all security and compliance requirements. (21 CFR Part 11, CDISC, HDS, ISO 27001, ICH GCP…). The eCRF enables real-time data entry and automatic validation of collected data, reducing data entry errors and data collection delays.
Datacapt enables you to carry out all the steps mentioned in this article. Thanks to its flexibility and wide range of features, our platform enables you to set up all your protocols quickly and easily, in just a few days.
In conclusion, the use of an eCRF (Electronic Case Report Form) in clinical trials can offer many advantages. However, designing an effective eCRF requires a suitable, easy-to-use solution. It is also important to ensure that patient data is anonymized to protect privacy and data confidentiality.
