Category: M

Missing Information

Potentially clinically significant gap in knowledge about the safety of a medicinal product for a specific patient population or concerning certain anticipated utilization (for instance

Read More »

Medication Error

Any mistake in the way a medication is taken or administered (prescription, storage, dispensing, preparation, administration…), that has the potential to harm the patient. Medication

Read More »

Multicenter Trial

A clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out bymore than one investigator. Source: FDA

Read More »

Monitoring Visit Report

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs. Source: ICH E6

Read More »

Monitoring Visit

An oversight visit to a clinical trial site to review the progress of the study and ensure protocol adherence, accuracy of data, safety of subjects

Read More »


The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol,

Read More »

Medical Device

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended

Read More »

Manufacturing Supplement

[FDA] a supplement to an approved application which includes a change(s) to the manufacturing process, including product testing or changes to the facility(ies) involved in

Read More »

Register to access to our exclusive library!

Highlight Post

Recent Posts