Clinical research platform for managing COVID-19 patient data and beyond

Anna Lewandowska (Clinical Trials Implementation Manager)

When novel strains of viruses like the Coronavirus (SARS-CoV-2) emerge, the data quickly becomes the most valuable asset. Effectively capturing data and accurately reporting it enables researchers to learn as much as possible about the disease, clinical phenotypes and treatment interventions. Whether simply documenting data through interviews, designing new studies or finding evidence-based answers to specific clinical situations, it is essential to capture the patient data that can be shared, compared and re-used.

However, many health information professionals in inpatient and ambulatory care settings are still struggling with challenging questions such as what needs to be captured, how the data should be coded and reported, and how the data should be presented accurately. “There is an urgent need to streamline data collection and facilitate workflows in the studies.” [1]

Responding to this, Veridata EDC has developed the ready-to-use electronic Case Report Form (CRF) based on the WHO-ISARIC form [2], with built-in data validation checks. To accelerate collective understanding of the disease and global clinician collaborations and to ultimately improve patient outcomes, Elsevier has been sharing all the latest COVID-19 related medical and scientific information across journals, Life Sciences and clinical resources.

Elsevier is now offering clinical researchers free access to Veridata EDC. A flexible, cloud-based solution providing immediate multi-user online access to data, Veridata EDC is compliant with HIPAA, GDPR, GCP and FDA 21 CFR Part 11. If you are a researcher working or planning to capture COVID-19 patient data, visit the Coronavirus Research Hub to learn more about the free access, or simply contact Elsevier customer support via e-mail at covid19@elsevier.com and apply for a demo account. Following the necessary compliance training, you will receive a free 12-month license.

Standard clinical data collection

World Health Organization (WHO) and International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) have developed the COVID-19 Case Report Form (CRF) for collecting data on individuals presenting with suspected or confirmed COVID-19 (Figure 1).

Figure 1: WHO-ISARIC COVID-19 Core Case Record Form (under the license CC BY-SA 3.0 IGO)

Figure 2: Veridata EDC COVID-19 Core Case Record Form based on WHO standard

To support data entry, studies setup and voluntary reporting, Veridata EDC has implemented the WHO-ISARIC form (Figure 2), with built-in data validation checks. Researchers can use Veridata EDC to:

  • capture data on individuals presenting with suspected or confirmed COVID-19,
  • access data from multiple hospitals simultaneously in real-time,
  • create study schedules and modify the standard forms with questions tailored to the specific studies,
  • design your own study data set so you can focus on your custom research questions,
  • report and share COVID-19 patient data using WHO standards,
  • combine multiple data sets to increase the scientific power of your research and subsequent systematic reviews,
  • analyse data over time and publish own research studies,
  • respond rapidly to future waves and next pandemics, etc.

Watch the introduction and short demo of Veridata EDC.

If you are a researcher working on or planning to capture COVID-19 patient data, visit the Coronavirus Research Hub to learn more about the free access, or simply contact Elsevier customer support via e-mail at covid19@elsevier.com and apply for a demo account. Following the necessary compliance training, you will receive a free 12-month license. Together, we can beat the pandemic.

[1] Elsevier launches Veridata™ Electronic Data Capture (EDC) and offers free access to help researchers studying COVID-19

[2] World Health Organization. Global COVID-19 Clinical Platform. NOVEL CORONAVIRUS (COVID-19) - RAPID VERSION