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Standardised MedDRA Queries SMQs are validated, pre-determined sets of MedDRA terms grouped together after extensive review, testing, analysis, and expert discussion SMQs are a unique feature of MedDRA and provide a strong tool to support safety analysis and reporting
Standardised MedDRA Queries (SMQs): Programmers Approach from . . . Standardised MedDRA Queries (SMQs) are groupings of MedDRA terms, ordinarily at the Preferred Term (PT) level that relate to a defined medical condition or area of interest SMQs are intended to aid in the identification and retrieval of potentially relevant individual case safety reports
Practice of SMQs for Adverse Events in Analysis of Safety Data and . . . SMQs (Standardised MedDRA Queries) were created to standardize identification and retrieval of safety data SMQs are a joint effort of the Council for International Organizations of Medical Sciences (CIOMS) and ICH representing both industry and regulatory authorities
Standardised MedDRA Queries (SMQs) MedDRA was developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
FMQs vs SMQs | Rho Sponsors often rely on Standardized MedDRA Queries (SMQs) to group adverse events for detection of safety signals across clinical trials Additionally, the FDA has introduced their own version of adverse event groupings – FDA MedDRA Queries (FMQs) So, what’s the difference?
Standardised MedDRA Queries (SMQs) Standardised MedDRA Queries (SMQs) are used to support signal detection and monitoring SMQs are validated, standard sets of MedDRA terms These sets of terms have undergone extensive review, testing, analysis and expert discussion
MedDRA and SMQs - Pharmaacademias Standardized MedDRA Queries (SMQs) are pre-defined sets of MedDRA terms that are grouped together to assist in identifying specific medical conditions or safety issues
Microsoft PowerPoint - SMQ_rev_Jan_2013. pptx - MedDRA In case of any adaption, modification or translation of the presentation, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original presentation