protocol amendment

protocol amendment

In clinical trials, a written description of one or more changes to, or formal clarifications of, the study protocol.
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has announced it has won conditional approval of a study protocol amendment from the U.
Our Opteon(TM) product line is the key to this reduction, and will be instrumental to enabling further reductions that would be achieved through a Montreal Protocol amendment.
The Company further announced it would conduct "Part Two", with a protocol amendment that primarily evaluates the effects of food on PK parameters, with dosing expected to commence and be completed within the current quarter 2015.
Data recorded for each protocol submission included whether this was a first application or a protocol amendment, the sponsor of the trial, the principal investigator (PI), phase of trial (I, II, III or IV), and the year and month of submission.
Based on these favorable data, two actions are anticipated: (1) expansion of the initial cohort treated on the once-every-3-weeks dosing schedule from 25 to 40 patients; and (2) a protocol amendment to evaluate dosing on an alternate schedule (i.
We submitted a protocol amendment to the FDA in August in order to open the study to patients suffering from these non-Hodgkin's B-cell lymphomas," stated Leslie J.
Price said, "The upcoming meeting will include discussions on a Montreal Protocol amendment to address emissions of hydrofluorocarbons, potent greenhouse gases that are replacing ozone-depleting substances and are rapidly becoming a major contributor to global climate change.
Following support from the FDA and EMA, the company is proceeding with its planned protocol amendment globally.
Chapter 8 elaborates the clinical trial protocol amendment.
A protocol amendment has been completed to explore the pan-genotypic clinical efficacy of PPI-668 in HCV genotype-2a/3a patients.
International clinical trial in hemophagocytic lymphohistiocytosis implements protocol amendment.
Additionally, the Company reported that it plans to submit a protocol amendment this quarter to its ongoing Phase 2 study in genotype 2 and 3 HCV-infected patients to include the evaluation of 100 mg and 200 mg of INX-189 dosed once-daily in combination with RBV for 12 weeks.