Clinical Data Mapping Software
The Study Data Tabulation Model (SDTM) is a data collection methodology for human clinical studies. The Clinical Data Interchange Standards Consortium (CDISC), a renowned organization that deals with clinical research databases, developed this format. That is after the experiment is over, you must put the material into the FDA-approved table style.
SDTM is a standardized format helping to arrange trial data and review it easily without wasting time on defining domain and variable names. By applying SDTM, you’ll be able to identify any data due to standard naming and variables, which vouches for precise and consistent outcomes.
SDTM is often based on clinical observations that are grouped into data classifications such as interventions, events, and results. It is also feasible to provide information on a subject’s medical history and key symptoms.
As usual, SDTM mapping is conducted at the end of clinical research after collecting all the data about a patient’s health state. However, it can be troublesome to fit the SDTM layout. So, it’s preferable to integrate the given datasets with the CDISC criteria in advance.
How to Deal with Clinical Data SDTM Mapping to Get Precise Outcomes
When dealing with clinical data mapping, you need to be very attentive and know well the particular domains, rules, and samples. If you find it daunting, don’t waste time and apply the Formedix Ryze platform to guarantee proper model implementation and mapping of clinical data.
It’s vital to outline what domains to create, define variables for datasets, map them to the SDTM variables, validate SDTM data, etc. As you see, SDTM mapping is a complex and intricate task that requires enough time, analytical, and technical skills.
To facilitate the process of mapping the clinical data, use the Formedix ryze software. We have an immense experience of over 20 years in clinical data performance, so you can lean on us if you need SDTM automation, get compliance with CDISC, FDA, or NCI standards, and design your study research.
With the Formedix Ryze, you’ll manage to map data from a non-CDISC structure according to the SDTM standards. You’ll succeed in applying correctly an SDTM mapping plan to manage the required datasets:
- Outlining the datasets that must be mapped.
- Transform dataset variables into SDTM domain variables.
- Identifying SDTM datasets that are compatible with the selected data.
- Obtaining information from datasets that conform to the SDTM.
- Making custom domains for datasets that do not have SDTM datasets.
The Formedix Ryze software is a reliable platform to arrange clinical trial information, edit it anytime, comply with the SDTM criteria, and make it accessible to medical trial researchers.
There can be variables that shouldn’t be modified, or there are variables that you need to rename to meet the SDTM criteria. Besides names of variables, it’s compulsory to change attributes such as type, length, and format to resonate with SDTM.
Using the Ryze program, you will mix, divide, or derivate SDTM variables to fulfil SDTM criteria. Our proven clinical data mapping software helps accelerate your SDTM data conversion from the EDC system into CDISC datasets. Given the fast changes in the regulatory environment, we seek to aid clinical trial analyses in becoming CDISC-relevant.