An Electronic Case Report Form (eCRF) software —also known as Electronic Data Capture (EDC) system— is an essential tool in clinical trials.
What is an eCRF? Basically, an eCRF is a web-based software application used to collect clinical data in a clinical trial.
Given its importance, the cost of the eCRF (and related professional services) must always be included in a clinical trial budget.
Which are the costs involved in designing, implementing, testing, validating, and using an eCRF?
Let’s explain in further detail the main cost items involved in building and deploying an eCRF. We will structure these costs in five sections:
- Data Management
- eCRF Build / Implementation
- Statistical Programming
- Project Management
- eCRF Software License and Hosting
For the example described in this article, we will assume a phase 1 clinical trial with 18 patients to be enrolled by a total of 5 clinical sites.
The start-up (system design, implementation, testing, and validation) stage will last 3 months, plus 12 months of system usage (data collection / cleaning), 1 month for analysis, and 1 month for close-out (17 months 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 to be analyzed in a clinical trial. These tasks are essential to guarantee the quality and accuracy of clinical data, and to comply with Good Clinical Practice (GCP) guidelines and international standards.
Firstly, two key documents should be developed: the data management plan (DMP) and the data validation plan (DVP).
The purpose of the DMP is to ensure that there are procedures and controls in place to protect the data of study participants and ensure the authenticity, accuracy, and integrity of trial data.
Usually, a DMP includes information about database development and implementation, staff trainings, data entry and processing, data quality assurance, study close-out and database lock, security aspects, and record retention.
On the other hand, data validation is the process of testing the validity of clinical data in line with protocol specifications. Data validation rules are documented in a DVP.
Edit check mechanisms are implemented to identify the discrepancies in the collected data, to guarantee data validity. A discrepancy is understood as data that fails to pass a validation check. Discrepancies may be related to inconsistent data, missing data, or deviations to the protocol.
Writing a DMP and a DVP may imply an estimated effort of 74 hours, all together. At an hourly rate of US$ 70, this set of documents may cost $5,180.
Another important eCRF specification document is the annotated CRF, which is defined as a blank CRF with annotations, that coordinate each datapoint in a form with its corresponding dataset name. Then, an annotated CRF communicates where the data collected for each question is stored in the database.
Developing an annotated eCRF may have an approximate cost of $4,200, depending on the number of data forms and fields.
One of the key activities needed to ensure high quality data is the training of site staff in charge of entering data in the eCRF. Assuming 5 hospitals, and training conducted via teleconference, all the initial training provided to hospital users may have a cost of $350 from the CRO’s side.
As the clinical data is entered by sites in the eCRF, this information has to be reviewed by the data managers of the CRO.
Data managers will review and clean the data by issuing data queries (questions and clarification requests) to sites, keeping constant communication with hospital staff to stimulate data entry during the recruitment period.
For a system use period of 12 months (5 sites), data review and cleaning work is estimated at $21,000 total.
In parallel to eCRF usage, the system needs to be technically maintained while it is used (e.g. server maintenance, software updates).
At the same time, CRO data managers and technical personnel will provide support to sites (helpdesk) for any questions. This technical support effort via email and/or telephone can imply costs around $8,400.
Finally, within the data management section, three data categories require what is called “medical coding”, which consists of standardizing terms related to medical history, concomitant medications, and adverse events experienced by patients. These tasks would cost near $3,150.
Data Management Total: $42,280
2.- eCRF Build / Implementation
Once the specification documents of an eCRF have been written and approved, it is time to implement the system.
The eCRF implementation consists of actually creating the electronic data forms and fields in which the data will be entered. This work also includes the configuration of automatic queries and edit checks to detect data discrepancies. This first set of tasks within the eCRF implementation may add up to $11,200.
After the eCRF has been built, data managers have to test and validate the system by performing user acceptance testing (UAT).
UAT consists of testing the software by the user or client to determine whether it can be accepted or not. This is the final testing performed once the functional and system tests have been completed.
The main purpose of this testing is to validate the software against the system requirements. This validation is carried out by the end users who are familiar with the eCRF requirements.
UAT activities can be estimated at $2,800.
Finally, the implementation of the eCRF includes the set up of data exports. Data managers will develop export specifications to define how the data will be exported for further analysis, as required during the study.
Data export tasks (initial set up and subsequent export executions) are calculated around $5,600.
eCRF Build / Implementation Total: $19,600
3.- Statistical Programming
An additional specialized service that can be hired from a CRO is statistical programming.
What are the responsibilities of statistical programmers in clinical trials? Statistical programmers take care of the following tasks:
- Develop the Statistical Analysis Plan (SAP)
- Create specifications for derived/analysis datasets
- Program analysis datasets, tables, figures, and listings to support the analysis of clinical trial data using SAS
- Generate SDTM domains, ADaM datasets, and Define.xml files
- Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
- Perform quality control for SAS programs and other study documents
- Review output across programs to ensure consistency
- Provide technical oversight and leadership in the areas of data analysis and reporting
The work required to complete an SAP may be around $3,600, including tables, figures, and listings —TFL— shells.
Furthermore, statistical programming tasks, including interim and final analyses, can add up to $18,000 in the type of study we are considering.
Statistical Programming Total: $21,600
4.- Project Management
CRO Project Managers are the primary point of contact for the client and are responsible for facilitating integrated project delivery, oversight, and project management in all phases of the project life cycle.
The Project Manager’s goal is to ensure optimal project performance including overseeing project scope and profitability, managing resource utilization, meeting key timelines and milestones, complying with quality and compliance standards, and achieving a high level of client satisfaction.
Project Management Total: $47,600
5.- eCRF Software License and Hosting
In addition to the above mentioned professional services, the eCRF system itself implies a usage license and hosting expenses.
Different eCRF vendors have different billing schemes and cost plans, normally depending on study size (number of sites and patients) and duration (months of recruitment and follow-up).
Of course, one of the factors impacting the cost of an eCRF solution is its quality and technical features.
In the clinical research industry you can find big eCRF vendors with very advanced and powerful software products, with many years of development, as well as smaller providers with more modest and lower-cost applications (sometimes used in academic studies with lower budgets).
In general, monthly license and hosting costs for eCRF software products may be in the range of $1,000-5,000.
Assuming a monthly fee of $4,000, during 12 months of system use, the software license and hosting costs for our study are $48,000.
eCRF Software License and Hosting Total: $48,000
eCRF SYSTEM AND RELATED SERVICES TOTAL: $179,080
The eCRF software described in this article costs $48,000, and the whole project has a total cost of $179,080 when the related services are added.
The factors impacting the cost of an eCRF are the level of quality and sophistication of the system itself, the number of related professional services needed, and finally the size and duration of the clinical trial.
If you need an eCRF system and related services for your clinical trial, please contact us at firstname.lastname@example.org