Several challenges come with clinical data collection. One of the biggest problems is that different standards exist for different countries due to differences between regulations and laws.
In addition, a lack of standardization across studies and sites can lead to inconsistent use of terms and definitions, resulting in misinterpretation and invalid conclusions. This could also lead to misleading results upon submission or re-analysis.
Annotated CRF SDTM considers these challenges and ensures quality control over the clinical data collection process while meeting local requirements at every development stage. Here’s what you need to know about it:
Table of Contents
What Is CRF SDTM?
As you may know, CRF stands for case report form and is used as a questionnaire in clinical research. It’s essentially a paper or digital form that contains questions relevant to the study. SDTM refers to the study data tabulation model, a data format used by pharmaceutical companies and contract research organizations (CROs). It’s needed to transmit electronic data from studies to regulatory agencies.
CRF SDTM is a set of standard metadata for clinical research data. The standardized metadata collected by the CRF SDTM is used to create a standard, global format for analyzing clinical data from multiple sources and in multiple formats. The CRF SDTM standards allow researchers and analysts to integrate data from different sources into one data set.
CRF SDTM Vs. Traditional CRF
CRF SDTM is significantly different from traditional CRF in clinical data collection. The most obvious difference is that CRF SDTM is designed for electronic submission, whereas traditional CRF utilizes or requires paper. This is one of the main reasons that using CRF SDTM is often much cheaper than traditional CRF.
However, if you want to switch to e-CRFs and implement CRF SDTM in your project, it’ll still cost you money as you’ll have to invest in a new EDC system or check out formedix.com and other specialized companies to help with your migration.
One more difference between these two systems lies in their compliance. While traditional paper-based forms can be created by anyone and designed however one wants them to be, the design of an electronic form must follow specific rules. The e-CRFs used for collecting data are part of an overall CDISC model implemented for a single study: it’s impossible to create just one random form without following this framework.
How Does CRF SDTM Improve Clinical Data Collection?
The implementation of CRF SDTM brings several benefits to clinical data collection. The most important are listed below:
- Better data quality: Faster access to higher quality data means you can make better and more informed decisions throughout the study.
- Better study management: Compliance-ready data collected, cleansed, and monitored in a single system means fewer errors and less risk for regulatory issues.
- Better regulatory compliance: An automated process for transforming source files into CRF SDTM results in faster, more efficient submissions that improve compliance with regulations.
- Better operational efficiency: Standardized content across studies reduces the cost of development by reusing existing workflows and templates, cutting down training time.
- Better data accessibility: Clinical content is available in an open format that allows authorized users from different systems to access it remotely without compromising security or privacy.
- Better data sharing: Streamlined processes help speed up the availability of validated clinical content across departments within your organization or external partners involved in your clinical trials.
What Is The Process Of Annotating CRF SDTM?
For clinical data collection, a few different roles are involved in annotating the CRF SDTM. Organizations should select the right people to participate in this process, and they need to have access to a few different resources. These include:
- A copy of the CRF
- A copy of the SDTM mapping specification
- Access to the clinical data collection system
- Access to the clinical data management system
- Access to the clinical data warehouse
How Much Does It Cost To Annotate CRF SDTM?
There is no universal answer to ‘How much does it cost to annotate CRF SDTM?’ Here are two main factors that influence the annotation cost:
- The number of CRF pages
- The complexity of the study
A clinical data collection form can include one to dozens of pages. And while a small trial may contain only one document, there are likely multiple forms in any clinical study. It takes time to annotate each page, so the more information you have, the longer your data will take to annotate.
As for complexity, a trial that includes five different types of patients who need their data recorded in standard terminology will require more work than a similar trial with one type of patient. Considering these factors is essential for getting an accurate picture of how much time and money you can expect your project to cost.
Conclusion
The benefits of using CRF SDTM for clinical data collection go far beyond adhering to regulatory requirements. The standardization provided by CRF SDTM helps your business save money and time when managing and labeling data. It also assures that clinical trials are conducted at the highest level of quality possible.
