Exact(1)
Recognizing the benefit afforded to both applicants and reviewers in allowing revised applications, we instituted a closed (i.e., only open to individuals who submitted for the initial deadline) resubmission for the second and third year of the program.
Similar(59)
EFSA scientists based their conclusions on the data submitted for the substances' initial market approval, as well as later laboratory and field studies.
Income tax forms submitted for the past two years.
To safeguard the rights, safety, and well-being of all trial participants, and in compliance with the responsibilities of IRBs outlined in the ICH Guideline for Good Clinical Practice [ 8], all clinical studies, including studies involving minority groups, submitted for initial review by the FTM-EC, underwent full-board review, and none was exempted.
All clinical and 2/3 of non-clinical studies submitted for initial review underwent full-board review.
Of 291 proposals submitted for initial review, 77.3% (225/291) underwent full-board review, 20.3% (59/291) expedited review, and 2.4% (7/291) were exempted from ethical review.
During the 3-year study period, 96 clinical and 195 non-clinical studies were submitted for initial ethical review, and 43 clinical and 39 non-clinical studies for continuing review.
The outcomes of initial review found in this study are similar to studies submitted to IRBs in Africa and South America [ 13- 15], which also reported that 80-90% of protocols submitted for initial review were referred back to investigators for clarification and/or revision.
We considered claims for metronidazole or oral vancomycin prescriptions submitted after claims for the initial therapy and within 180 days of the diagnosis date to be markers for CDI recurrence or relapse.
The EC said EU Member State Austria submitted the initial request, with Iceland, Italy, France, Norway, Spain and Sweden joining subsequently.
Papers which pass the initial scan are submitted for detailed manual curation, while the remaining papers are 'listed' on the COSMIC website.
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