Clinical Training Agency

Clinical Trial Authorisation, the authorisation from the MHRA to conduct a CTIMP. No CTIMP can commence in the UK without both a CTA and a favourable ethical opinion. Applications to the MHRA and the REC may be made in parallel.

Clinical Trial Assistant. Person who assists in the day-to-day operations of a research project

Clinical trial application is filed in Canada to get approval prior to doing a clinical trial.

Clinical Trial Application. Before initiating a clinical study in a Member State (MS) of the European Union (EU), a positive opinion must be given by the Competent Authority of that MS to the Clinical Trial Application (CTA) submitted in support of the study. The CTA documentation will provide medical and scientific justification for the proposed clinical study. The CA has a maximum period of 60 days to respond to the applicant. Note that approval for the study must also be given by an Independent Ethics Committee (IEC) in that MS.

Clinical Trial Authorisation. The authorisation issued by the MHRA in the case of a CTIMP. No CTIMP can commence in the UK without the issue of both a CTA and a favourable ethical approval. Applications to the MHRA and the REC may be made in parallel.

Clinical Trial Applications, an application submitted to the TPD in order to begin a study on humans. The CTA shows results of previous experiments; how, where and by whom the studies will be conducted; the compound's chemical structure; proposed mechanism; toxic effects on animals; and manufacturing methods.

CLINICAL TRIAL APPLICATION. A Clinical Trial Application must be filed with Health Canada before an experimental drug can be studied in a Phase I, II or III clinical trial (Phase IV trials do not need to be filed).