What Is the Price of an Electronic Case Report Form (eCRF)?

What Is the Price of an Electronic Case Report Form (eCRF)?

If you need a quotation for an electronic case report form (eCRF), you can contact us at info@klindat.com

Electronic case report forms (eCRFs) are key software applications in clinical trials. 

What is an eCRF? Essentially, an eCRF is a web-based software tool used to collect, clean, process and transfer data in a clinical trial.

As an indispensable system, the cost of an electronic case report form —and associated data management services— should always be included in a clinical trial budget.

The services related to the eCRF are usually provided by a company called Clinical Research Organization (CRO), which has a biometrics department.

In this article, we will detail the main costs associated with an electronic case report form.

These costs will be grouped into three sections:

  1. Data management
  2. Statistical programming
  3. Licensing and hosting of the eCRF

For the example explained in this article, we will assume a phase 1 clinical trial in oncology with 15 patients to be recruited in a total of 4 hospitals.

The start-up stage (design, implementation, testing, and initial validation of the system) will last 4 months, plus 27 months of system use (including recruitment, treatment, and survival follow-up), and 3 months of analysis and closure (34 months in total for the entire project).

1.- Data management

An eCRF software requires a set of specialized data management services.

Data management includes activities related to the entry, cleaning, transmission, and preparation of clinical data for analysis in a clinical trial.

These tasks are essential to ensure the quality and accuracy of clinical data, and to comply with Good Clinical Practice (GCP) guidelines and international standards.

Data Management Plan (DMP)

First, a key document must be developed: the Data Management Plan (DMP).

The purpose of the DMP is to guarantee that procedures and controls are in place to protect patient data and to ensure the authenticity, accuracy, and integrity of trial data.

In general, a DMP includes information on database development and implementation, staff training, data entry and processing, data quality assurance, study closure and database locking, security issues, and information storage.

Writing a DMP can cost around 2,800 €.

Data Validation Plan (DVP)

Moreover, data validation is the process of testing the validity of clinical data according to protocol specifications. Data validation rules are documented in a Data Validation Plan (DVP).

In clinical trials, verification mechanisms are implemented to identify discrepancies in the collected data to ensure the validity of the information.

A discrepancy is defined as data that do not pass a validation check. Discrepancies may be related to inconsistent data, missing data, or protocol deviations.

Writing a DVP can cost around 2,800 €.

Annotated CRF

Another important eCRF specification document is the “annotated CRF”, which is defined as a blank CRF with annotations, linking each piece of data in a form to its corresponding dataset name.

Developing an annotated CRF can cost approximately 4,200 €, depending on the number of forms and data fields.

eCRF completion guide

Another necessary tool is the eCRF completion guide, which may have a development cost of around 560 €.

Implementation of the eCRF

Once the specification documents of an electronic CRF have been written and approved, it is time to implement the system.

The building of an eCRF consists of the actual creation of the forms and data fields into which the data will be inserted.

This work also includes the configuration of automatic queries and control mechanisms to detect data discrepancies.

This set of tasks related to the building of an eCRF amounts to 10,500 €.


Once the electronic CRF has been created, data managers must test and validate the system by performing user acceptance testing (UAT).

UAT consists of testing the software by the user of client to determine whether it can be accepted or not. This is the final test performed after functional and system tests have been completed.

The primary purpose of this testing is to validate the software against the system requirements and expected functions. This validation is carried out by a user who is familiar with the requirements of the eCRF.

UAT activities can be estimated at 2,800 €.


One of the fundamental activities required to ensure high quality data is the training of hospital personnel in charge of entering data into the eCRF.

Assuming 4 hospitals and training done by teleconference, all initial training provided to hospital users can be charged at a cost of 840 € by the CRO.

Changes to the eCRF

Once the study has started, it is likely that changes to the electronic CRF will be necessary due to unforeseen needs. A budget of 1,680 € is budgeted for these potential modifications.

Data cleaning

Since clinical data are entered into the eCRF by users located in the hospital, this information must be reviewed by the CRO’s data managers.

Data managers will review and clean the data by issuing data queries (questions and requests for clarification) to clinical sites, maintaining constant communication with hospital staff to encourage data entry during the recruitment period.

The effort required to clean the data of 15 patients in the proposed clinical trial is valued at 6,300 €.

Reconciliation of serious adverse events (SAEs)

Another task commonly performed by data managers is to reconcile the serious adverse events (SAEs) reported by hospitals versus the serious adverse event information entered into the eCRF. The aim is to ensure that the data received through both channels match.

Reconciliation of SAEs has a cost of 700 €.

Technical support

At the same time, the CRO’s data managers and technical staff will provide support to the hospitals (helpdesk) for any questions or difficulties.

This technical support effort via email and/or telephone may involve a cost of around 3,780 €.

Medical coding

Finally, within the data management section, three categories of data require what is known as “medical coding”, which consists of standardizing terms related to medical history, concomitant medication and adverse events experienced by patients. These tasks would cost about 2,100 €.

Total data management: 39,060 €.

2.- Statistical programming

An additional specialized service that can be contracted to a CRO is statistical programming.

Statistical programmers are entrusted with the following tasks:

  • Develop the Statistical Analysis Plan (SAP).
  • Create specifications for data sets.
  • Develop programs, tables, figures, and lists to perform data analysis using SAS.
  • Generate SDTM domains, ADaM datasets and Define.xml files.
  • Provide programming support for complementary or exploratory analysis.
  • Perform quality control of SAS programs and other study documents.
  • Review results from all programs to guarantee consistency.
  • Provide technical oversight and leadership in the areas of data analysis and reporting.

The work required to complete an SAP can be around 2,800 €, including tables, figures, and listings (TFL).

Additionally, statistical programming tasks as such (using SAS), including interim and final analyses, can add up to 17,500 € for the type of study that is being considered.

If needed by the customer, statistical programmers could work to implement the SDTM and ADaM standards, which would require a substantially higher cost (price not included in this example).

Total statistical programming: 20,300 €.

3.- eCRF license and hosting

In addition to the services listed above, the eCRF software product involves a license fee and hosting costs.

Each eCRF vendor has different billing schemes and cost plans, usually depending on study size (number of sites and patients) and duration (months of recruitment and follow-up).

In the clinical research industry, eCRF vendors with very advanced and powerful software products can be found, as well as smaller vendors with more modest, lower-cost applications (sometimes used in lower-budget academic studies).

Generally, monthly licensing and hosting costs for eCRF software products can range between 400 € and 4,000 €.

In our example, we will consider the Klindat eCRF software. For 27 months of use, at 400 € per month, the price would be 10,800 €.

Total license and hosting of the eCRF: 10,800 €.



The electronic case report form described in this article costs 10,800 € and the entire project has a total cost of 70,160 € when related services are added.

Factors that impact the price of an eCRF are the technical features of the system, the number of related services needed and, finally, the size and duration of the clinical trial.

If you need a quotation for an electronic case report form (eCRF), you can contact us at info@klindat.com

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