Key points
- An eCRF captures all information required by the protocol, and no more, according to the EMA guideline (2023).
- Edit checks must be relevant to the protocol, validated and documented (EMA, 2023).
- An eCRF configuration is tested before release to production, with its future users where possible.
- A patient code such as CENTRE-0001 pseudonymizes the data: according to the CNIL, the data remains personal.
How to define an eCRF?
The eCRF (electronic Case Report Form) is the electronic data entry form of an electronic data capture (EDC) system. 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: Article 9 of the GDPR covers health data, but also sexual orientation, ethnic origin and religious beliefs. Processing these data is prohibited unless an exception applies. In France, research that fully complies with a reference methodology of the CNIL, the French data protection authority, such as MR-001, is exempt from requesting authorization; otherwise, CNIL authorization is required.
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. Our guide shows how to write edit checks for each field.
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 pseudonymization
In accordance with the GDPR, all personal data collected must not be divulged, in order to guarantee the privacy of sensitive data and the confidentiality of volunteers. Patients’ identity must not appear in the eCRF for the duration of the clinical study: this is the role of pseudonymization. A unique code such as CENTRE-0001 is used to identify each patient. Pseudonymized data remains personal data: according to the CNIL, pseudonymization is reversible, unlike anonymization.
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.
What deliverable should each step of eCRF design produce?
Each step of eCRF design should leave a document that someone can review and check. The EMA’s 2023 guideline on computerised systems requires it: the trial-specific configuration is specified in advance, documented, verified against the protocol and tested before release to production.
The table lists the five steps of this article, with the deliverable for each and the text behind it.
| Step | Deliverable | What the texts say |
|---|---|---|
| 01. Study objectives and data to collect | The list of data to capture, drawn from the protocol | The data acquisition tool captures all information required by the protocol, and no more (EMA, 2023, section 4.7) |
| 02. eCRF structure | The specifications: forms, edit checks, calculations, access rights | Edit checks are relevant to the protocol, validated and documented (EMA, 2023, section 6.1.4) |
| 03. Getting started | The list of users with their roles and access rights, the training materials | The sponsor keeps a record of authorized users, their roles and their access permissions (ICH E6(R3), 2025) |
| 04. Validation | The test report and the signed release to production | The configuration is tested before release to production, with users involved where possible, and the release is signed off (EMA, 2023, annex 2) |
| 05. Pseudonymization | The participant coding rule, such as CENTRE-0001 | The sponsor uses an unambiguous identification code for each participant (ICH E6(R3), 2025, section 3.16.1) |
The work continues after the study starts. According to the EMA, an eCRF change required by a protocol amendment goes through the same testing process, and the sponsor decides whether it applies to all participants or only to those the amendment concerns. Our article Protocol Amendments: 5 Hidden Costs Your EDC Budget Misses details what a mid-study change costs.
For step 04, our article Computerized System Validation in Clinical Trials explains what is expected from testing.
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.
Synapse Medicine collected 100% of its PING trial data on Datacapt, across 200+ included patients.
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 pseudonymized to protect privacy and data confidentiality.
[[faq]]
Sources
- EMA, Guideline on computerised systems and electronic data in clinical trials (EMA/INS/GCP/112288/2023), 2023
- ICH, Guideline for Good Clinical Practice E6(R3), 2025
- European Union, General Data Protection Regulation (EU) 2016/679, Article 9, 2016
- CNIL, L’anonymisation de données personnelles (in French), page accessed on 14 October 2026
- CNIL, Traitements de données dans le domaine de la santé : les référentiels pour simplifier vos démarches (in French), page accessed on 14 October 2026
Should an eCRF collect all available data?
No. The EMA’s 2023 guideline requires the data acquisition tool to capture all information required by the protocol, and no more. ICH E6(R3) asks the sponsor to avoid unnecessary data collection. Data with no link to the study objectives adds work to data entry, monitoring and data protection.
Who validates the eCRF before the study starts?
The responsible party, sponsor or investigator depending on how the trial is organized, signs off the release after testing. The EMA recommends involving users in testing and, where possible, having someone other than its author run each test case. Training materials must be ready on the day of release.
Does a patient code make eCRF data anonymous?
No. Replacing a name with a code such as CENTRE-0001 is pseudonymization. According to the CNIL, the French data protection authority, pseudonymized data remains personal data, because identity can often be traced with third-party data, and the operation is reversible. The GDPR therefore still applies to eCRF data throughout the study.
How do you change an eCRF after the study has started?
Through a formal change control process. Under the EMA’s 2023 guideline, each request is documented and authorized, with a risk assessment and an assessment of its impact on the system’s validated state. The change is tested before release to production, like the initial configuration, including when it follows a protocol amendment.
With over 10 years of experience working in CROs, Khalil brings deep expertise in clinical trials and a clear understanding of the daily challenges faced by research professionals. His insights are grounded in real-world operations, making his perspective both practical and strategic.
Blog & News Datacapt
News, Articles, Resources et Tutorials.
