protocol amendment

protocol amendment

In clinical trials, a written description of one or more changes to, or formal clarifications of, the study protocol.
References in periodicals archive ?
The protocol amendment will expand patient eligibility and enable study investigators to administer AST-OPC1 to patients with injuries at one vertebral level higher than the trial's previous C-5 limitation, to the fourth cervical vertebra down, known as C-4, near the middle of the neck.
To address this challenge, we are implementing a protocol amendment for the ICT-107 trial that will modify some elements of how patients qualify for the trial, which is designed to accelerate the pace and efficiency of randomization.
Finally, during its Presidency, Athens hopes to be able to conclude the ratification process for the Kyoto Protocol amendment (Kyoto II).
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.
There was protocol amendment to include younger patients (50 to 54years of age) or those with less recent strokes (within 90 to 120 days before randomization) if they also had at least two additional vascular risk factors.
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.
Because of a protocol amendment during the study the end point was changed to cardiovascular hospitalization or all-cause mortality, which turned out not to be significantly different between the groups.
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.
The 40-month follow-up was approved as a protocol amendment by the local Institutional Ethics Committee, specifically to measure longer-term safety and efficacy end-points related to limb salvage, disease progression, and quality of life improvement.
The 40-month follow-up was approved as a protocol amendment by the local Institutional Ethics Committee, specifically to measure longerterm safety and efficacy end-points related to limb salvage, disease progression, and quality of life improvement.
The regulation will transpose the measures outlined by the Montreal Protocol amendment to the European Union and, even other countries.