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MedDRAMedical Dictionary for Regulatory Activities
MedDRAMedical Dictionary for Drug Regulatory Affairs
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REACTION Includes all adverse drug reactions coded by MedDRA terminology .
While there are thousands of potential AEs, very few are typically observed for many of the MedDRA preferred terms.
In addition, there are several levels of granularity in frequencies of adverse events and in reporting of adverse events (eg, MedDRA preferred terms and system organ class).
ADRs were coded by MedDRA with the highest degree of intensity and causality for evaluation including time course and causality.
Third, MedDRA coding terms might not accurately reflect the diagnosis of syncope.
It sure seems like the right thing to do," says Patrick Revelle, MedDRA MSSO.
2121 McCloud Consulting Group 502 McGuire Research institute 2041 MedDRA MSSO 711 Medical Starting Network Healthcare.
Rounding out the platform, the MedDRA adapter is the newest capability from Pilgrim, integrating with its Complaints Management solution to ease adverse event reporting to global regulatory bodies.
Target Health has also developed a full suite of eClinical Trial software including Target e*CRF([R]) (EDC plus randomization and batch edit checks); Target e*CTMS([TM]); Target Document([R]); (paperless TMF and beyond); Target Encoder([R]) (for MedDRA and WHO Drug); and Target Newsletter([R]).
Adverse events were classified according to MedDRA and the incidence of treatment-emergent events was summarized.