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We reviewed RCT protocols, statements of the principal investigator (PI), and participant-information materials, as submitted for opinion to a research ethics committee.
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A total of 57 criteria were retained for the prioritization method and further submitted for opinions of experts.
We would like to be wrong and remember, we cannot predict the timeline with more accuracy until a SEC proposal has been submitted for public opinion.
The scenario could have changed in Europe thanks to the publication of the detailed guidance on the modalities of clinical trial authorisation request to competent authorities [6], on the format of the application and the documentation to be submitted for EC opinion [7], and on investigational medicinal products and other medicinal products [8].
Results: Over a period of 40 months, 109 cases were submitted for second opinion consultation, including 29 dermatopathology cases (26.6%), 14 hematopathology cases (12.8%), and 13 cases each (11.9%) in cytopathology and bone and soft tissue pathology.
We analyzed a group of 193 consecutive nodal PTCLs from a larger series of cases submitted for diagnosis or second opinion to the CNIO Pathology Laboratory between 2000 and 2008.
Its work is carried out in six specialist committees, which draw up draft opinions and resolutions that are then submitted for adoption in plenary.
Opinions from both forums are in the process of being compiled in manuscript form and submitted for review.
Chemical Engineering Science, submitted for publication).
Res., submitted for publication].
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com