What is SOC MedDRA?

What is SOC MedDRA?

The MedDRA dictionary is organized with a five-level hierarchy. The highest or broadest level is System Organ Class (SOC), further divided into High-Level Group Terms (HLGT), High-Level Terms (HLT), Preferred Terms (PT), and finally into the most granular Lowest Level Terms (LLT).

How many different system organ classes SOC are present in MedDRA?

The 26 System Organ Classes (SOCs) represent parallel axes that are not mutually exclusive.

Which terms are included in MedDRA?

MedDRA includes standardised terms for:

• symptoms, signs, diseases, syndromes and diagnoses.
• medical device malfunctions.
• medication errors.
• medical, social and family history information.
• sites (e.g. application, implant and injection sites)
• medical and surgical procedures.
• approved uses for medications and medical devices.

How do I get a MedDRA ID?

MedDRA users can retrieve their organisation’s MedDRA ID and the email address for their organisation’s Primary Point of Contact. Users with an e-mail address at the organisation’s domain as registered on the subscription can retrieve their organisation’s MedDRA ID and password.

What does MedDRA stand for why adverse events and serious adverse events reported in clinical trials are coded for data analysis and reporting?

MedDRA – the Medical Dictionary for Regulatory Activities – is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines).

What is the most current version of MedDRA?

The English version of MedDRA 24.1 will be available for download on 1 September 2021. Translations for MedDRA Version 24.1 (including Brazilian Portuguese, Chinese, Czech, Dutch, French, German, Hungarian, Italian, Japanese, Korean, Portuguese, Russian, and Spanish) will be available for download on 15 September 2021.

What are the types of reports in pharmacovigilance?

Spontaneous Pharmacovigilance Reports

• Individual Case Safety Report (ICSR)
• Case medical information inquiries.
• Product complaints.
• Reports from medical representatives.
• Reports from competent authorities.
• Contractual partners (co-marketed products, in-licensing, out-licensing, and distribution partners).

What is MedDRA and how is it used?

MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre- marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation.

How do I download MedDRA?

To access MedDRA, a MedDRA ID, Password, and Unzip Password are required. Your organization’s primary and alternate contacts may retrieve your organization’s credentials to download the MedDRA files by using the Self Service Application (https://apps.meddra.org/selfservice/).

What is MedDRA and who uses it?

It is also used by industry, academics, health professionals and other organisations that communicate medical information. The TGA uses MedDRA terms for coding the reports it receives about adverse events.

How are MedDRA terms assigned to an adverse event?

Before a report is entered into the Database of Adverse Event Notifications – medicines, the relevant MedDRA terms are assigned to describe the adverse event and other medical terms as necessary. This results in a consistent terminology, which enables related adverse events in DAEN – medicines to be grouped together in the medicine summary.

What are gender-specific terms in medmeddra?

MedDRA generally excludes terms with demographic descriptors (age, gender, etc.), but some terms with gender qualifiers are included if the gender renders the concept unique. Organisation-specific coding guidelines should address instances when it is important to capture gender-specific concepts.

Are there any examples of MedDRA that do not reflect practices and requirements?

There may be examples that do not reflect practices and requirements in all regions. This document does not specify regulatory reporting requirements, nor does it address database issues. As experience with MedDRA increases, and as MedDRA changes, there will be revisions to this document.