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The most important requirements of the EDC system

The Electronic Data Capture (EDC) system should ideally meet all the requirements of a clinical trial. This is critical to the quality of data collection and project success.

In each study, we distinguish three main blocks of requirements. All of these should be taken into account when configuring the system. Only in this case, will the system be ideal for your clinical research.

Regulatory requirements

Regulatory requirements

The EDC system has to meet the following regulatory requirements:

  • 21 CFR Part 11 — the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES);
  • GCDMP (Good clinical data management practice);
  • FDA Guidance for Industry: computerized systems used in clinical investigations;
  • GDPR (General data protection regulation).

The EDC system for clinical trials must meet all of the above standards. It also must have documents of compliance. This is critical for proper data collection in accordance with industry regulations. And compliance documents will be needed in the case of regulatory audits.

Protocol requirements

Protocol requirements

The EDC system must comply with the requirements of the Clinical Study Protocol. During configuration, the values of the following parameters should be taken into account:

  • Study design;
  • Visit schedule;
  • Inclusion/exclusion criteria;
  • Type of randomization;
  • Laboratory data;
  • LAE\SAE reporting.

If the system is not clearly configured to these points and does not comply with the Protocol, there is a risk of collecting irrelevant data or lacking data that is needed for statistical processing.

Investigators requirements

Investigators requirements

The EDC system should be convenient for researchers to use. For convenience, many functions can be implemented, for example:

  • Intuitive system interface;
  • Hidden fields for convenient filling out of eCRF;
  • Instant data saving and contingency data recovery.

These and other factors are essential for the rapid and quality input of data by the researcher. As researchers are often limited in time, the EDC system should have a set of various supporting functions that facilitate their work.

OnlineCRF EDC system is configurable with a thorough implementation of all these requirements. We do our best to get you a system that 100% meets the needs of the clinical trial.

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