Agatha Archives

Data Monitoring Committee (DMC)A group of independent experts who evaluate whether a study is ethical and scientifically sound. They may also decide whether to stop a study early because it is ineffective, harmful, or unlikely to help patients. Members are often drawn...

Data Definition FileA dataset description defines the format and content of each dataset. File,characters,options,object,values,encoding,code,service types,file format,service definition files,File Type,portable file,ArcGIS,ArcGIS Server,ArcGIS Online. Negative...

DailyMedDailyMed provides drug information for humans and animals, and for additional products including medical gases, devices, cosmetic products, and nutritional supplements. Patients,dose,reactions,adverse reaction rates,study,exposure,risks. Uncertain size,causal...

Crossover StudyA crossover study where participants act as their own controls and are randomly assigned to one group receiving investigational product first and then placebo second or vice versa....

Corrective And Preventative Action (CAPA)Process improvements, which include eliminating causes of undesirable situations or mitigating their effects, are often referred to as “root cause analysis” (RCA). Action,preventive action,root,requirements,quality,corrective...

Core Data Sheet (CDASH)An official working document prepared by manufacturers typically contains material related to efficacy, contraindications, warnings, precautions, adverse events, interactions, clinical trials, and other important information regarding their...

Controlled VocabularyA fixed set of standardized terms. Terms,headings,content,controlled vocabulary,searches,types,subject headings,users,keyword,preferred terms,vocabulary terms,narrower terms,file,labels,cataloging,entries,form. Retrieval,Subject...

Controlled StudyA randomized controlled trial that compares two groups. One of these groups receives an active intervention, whereas the other one doesn’t receive any intervention whatsoever. Trials,study,patient,participant,drug,effects,type,life,clinical...

Contract Research Organization (CRO)An individual or company hired by a sponsor to perform certain tasks related to the study Trial,clinical trials,Contract Research Organization,drugs,quality,clinical research organization,expertise,technology,success,strategies....

Concerned Member State (CMS)Other countries that may perform their own reviews of an application for approval during or after the reference member state has reviewed the application. Decision,decentralised procedure,products,procedures,submission,time,Mutual...