MedDRA dictionary in eCRF.

Medical coding.

Using the license, we have equipped eCRF.biz^TM system with the MedDRA medical dictionary containing international medical terminology used in clinical trials, clinical trial reports, data presentation and medical coding.

The use of the MedDRA dictionary in the eCRF system provides global standardization of terminology in a regulatory-compliant study and allows to properly classify diseases, diagnoses, symptoms, therapeutic indications, tests, procedures, and medical history of patients.

Implementation of this dictionary helps our data management team to perform medical coding in accordance with MedDRA specification and reduces the workload for Investigators during filling in eCRF due to in-built as you type suggestions system.

After typing few letters into adverse event or medical history input fields a physicians can choose suitable low level term from the list of matching proposals, which make the process of medical coding, necessary in the preparation of a clinical study report, substantially easier. Data Managers use the dictionary in the Autocoder application, which allows partial automation of the medical coding process and verification of coding by Medical Monitors or other persons. The process of medical coding, like other aspects of work in the system, is documented using the audit trail module.

Other eCRF system functions.

Protocol deviation log

CRO

Clinical trials

Drug clinical trials

Medical device clinical trials

Non-commercial clinical trials

Observational studies

Pharmaceutical market research

Research and development

Trainings and consulting

Monitoring

Real-World Data

Digitization of the data collection process

Offer

Frequently asked questions.

What are the benefits of using the MedDRA dictionary?

It facilitates the medical coding process, reduces the workload for doctors during data entry, and allows statistical experts to perform medical coding in accordance with the MedDRA standard.

Do doctors have support in medical coding?

Yes, doctors can use a hint list with preferred terms, which simplifies the medical coding process.

Is the medical coding process documented somewhere?

Yes, this process, like many other aspects of work in the eCRF system, is documented using the audit trail module.

e-mail

biuro@biostat.com.pl

telephone

+48 668 300 664

Kowalczyka 17
44-206 Rybnik
Poland