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 €.

Testing

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 €.

Training

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 €.