Examples of using Study protocol in English and their translations into Greek
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Medicine
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Financial
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Official/political
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Computer
Study protocol within 2 months after Commission Decision.
The characteristics that prevent a subject from participating in a clinical trial,as outlined in the study protocol.
The study protocol should be provided within the RMP.
A record of pertinent information collected on each subject during a clinical trial,as outlined in the study protocol.
Observational study protocol for inf for treating multiple sclerosis.
Exclusion Criteria- Refers to the characteristics that would prevent a subject from participating in a clinical trial,as outlined in the study protocol.
The study protocol was submitted to the RMS and all CMSs.
The Institutional Ethics Committee approved the study protocol and written consent was obtained from all participants.
The study protocol should be submitted within 3 months of the EC decision.
A list of characteristics or criteria,any one of which that would exclude a participant from a clinical study as outlined in the study protocol.
The study protocol will be finalised and submitted to the EMEA by July 2008.
The hospital's Institutional Review Committee on Human Research approved the study protocol and all participants provided informed consent.
Final study protocol should be submitted within 3 months after CHMP Opinion.
The CHMP noted that the expansion of the stated confidence interval for Cmax was not prospectively defined in the study protocol.
A study protocol must be approved by an IRB before investigational drugs may be administered to humans.
This situation should have been foreseen and included in the study protocol and the CHMP therefore considers this to constitute a major objection.
The study protocol and consent forms were reviewed and approved by Copernicus Group IRB(Protocol HI001).
However, the CVMP considered that it was inappropriate to exclude results from a bioequivalence analysis if provision for this had not been made in the study protocol.
The study protocol needs to be developed and presented for PRAC review within 2 months after the EU Commission Decision.
The MAHs undertook the commitment to investigate the feasibility of a long term study on the children development and to provide a study protocol, as requested by the CHMP.
The study protocol shall be entered in the EU electronic register of postauthorisation studies(EU PAS Register) before the start of data collection.
The CMDh considered that the timeline for the submission of the drug utililsation study protocol should be extended in order to allow MAHs to perform a joint post-authorisation study(see Annex IV).
The study protocol, including key aspects of the DMC charter, has to be agreed before initiation of the study. .
Patients in the phase II study who underwent complete resection of giant cell tumour of bone did receive an additional 6 months of treatment following the surgery as per study protocol.
It is the responsibility of the IRB to review the study protocol or research plan and ensure that risks to patients are minimized and that the study complies with all necessary guidelines.
The reporting Member State and the other concerned Member States need to organise themselves in a way that the competent authority concerned receives approval by an ethics committee on the clinical performance study protocol.
Being implemented through a study protocol, which has been accepted by the national authorities and the ethical review board in Kinshasa, as well as MSF's ethical review board.
The applicant will implement collection of material for biomarker investigation andanalyses of biomarker data into the study protocol of all new oncology studies planned for nintedanib in the future, wherever clinically appropriate.
Results from this present study could have been influenced by a number of factors including the small sample size, lack of a control group, duration of mango supplementation, inaccurate self-reporting of dietary intake andphysical activity level by study subjects, or from lack of compliance with daily mango supplementation as part of the study protocol.
This vaccine has not yet been licensed and is therefore being implemented through a study protocol, which has been accepted by the national authorities and the ethical review board in Kinshasa, as well as MSF's ethical review board.