Agatha Archives

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...

Complete Response LetterAn FDA letter informing an applicant of any deficiencies in their submission. Development,complete response letter,drug,application,response,diseases,treatment,review,factors,efficacy,biopharmaceutical companies,resubmission,time,request,Risk...

Common Technical Document (CTD)A CTD is a format used by pharmaceutical companies when submitting their marketing applications to the International Conference on Harmonization (ICH). Module,documents,registration,files,safety,drug,dossiers,Canada,Health...

Committee for Medicinal Products for Human Use (CHMP)"In Europe, the EMA's main task is to evaluate new drugs and medical devices before they become available on the market. It has three committees: one for medicinal products for human use (CHMP), one for cosmetics...

Clinical Trial Applications (CTA)“The European Union (EU) has a system for reviewing and approving individual research projects called Clinical Trials Authorisation. Each member state reviews and approves individual research proposals before they are accepted by the...

Clinical Study ReportA full report of a trial/studies of an investigational drug or device conducted in humans. Trial,study,time,safety,review,outcomes,risk,submission,placebo,adverse events,event,clinical study,product,clinical trial,clinical study reports,study...