Articles

Information Contained in Electronic Health Record

Electronic health record (EHR) comprises of patient’s medical history, diagnoses, medications, treatment plans, allergies, immunization dates, laboratory results, and radiology images. EHR may also include administrative data, such as demographics and insurance information. EHRs are stored in digital format and can be easily shared across different health care organizations and providers like clinics, laboratories, medical…

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Advantages of Electronic Medical Record in Clinical Trials

An electronic medical record (EMR) provides in-depth information about the patient’s medical condition. It typically contains the details you would find in a patient’s chart, such as medical history, diagnoses, medications, immunization dates, and allergies, stored in digital format. The rise in EMR implementation in clinical care has also increased the usage of electronic data…

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Coding Group Organizational Models

In the early days of MedDRA coding it was hard to find a health care professional who had any experience coding MedDRA. Many companies had to adopt a hybrid approach to coding. An example of this would have been when a Data Manager performed the coding and the oversight would be carried out by an…

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Why not choose your own System Organ Class?

For a long period of time I have used MedDRA and I have sometimes contemplated why as a coder we cannot choose our System Organ Classes in the same way that many companies choose to select WHO Drug ATC codes.  I have had calls from Medical Monitors requesting just that.  The answer according to the…

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Coded Data Quality

The quality of data received can vary wildly.  From a CRO’s interpretation of your data to in-house CDM’s who use other information to code a term, this highly regulated industry leaves a lot of room for error.  The global effort to harmonize good quality data is an ongoing and sometimes uphill battle. Every time a…

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Part 7: Important Considerations when Shopping for EDC

In the seventh and final part of our series entitled, Important Considerations when Shopping for EDC, we will discuss the upfront cost structure of an EDC system and what the costs vs. benefits are. Despite EDC’s established history and a perception that “Everyone is using an EDC System”, several Pharma and Medical Device Sponsors continue…

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Tricky Coding Issues II

Pharmaceutical Industry coding is a global affair, meaning many an issue may arise that can affect coding choices based on one’s geographic location and cultural understandings.  When reviewing or performing coding in regions where specificity, consistency and cultural and national differences may impact the way a medical concept is understood, it is important to grasp…

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Tricky Coding Issues

Coding in MedDRA is fraught with pitfalls and conceptual shades of grey.  How and why we find a code that will represent the event presented best requires some coding practice predetermination in some cases that would otherwise become a challenge.  Here are a few examples of how early decision making can minimize your efforts in…

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Part 6: Important Considerations when Shopping for EDC

In the sixth part of our series entitled, Important considerations when shopping for EDC, we will discuss allowing enough time to complete the validation testing. Validation is a critical requirement of both 21 CFR Part 11 and of GCP.  So permitting enough time for a thorough and complete validation is essential to demonstrating that your…

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Part 5: Important Considerations when Shopping for EDC

In the fifth part of our series entitled important considerations when shopping for EDC, we will discuss how to confirm that the EDC System can integrate with other systems such as CTMS thereby adding many useful features. Electronic Data Capture (EDC) has been a big focus for more than a decade. But Electronic Data Capture…

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