Sentences with phrase «study operations manuals»
Prepare Coordinate, review and finalization of various clinical operations / trial - related documents (i.e., Trial master file, protocols / amendments, informed consent forms, Study operations manuals / sheets, advertisements, data management / analysis plans and clinical study reports) according to ICH - GCP guidelines and CFR Part 11 for completeness, accuracy and legibility.
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In addition, clinical centers had access, via the study website, to the study manual of operations that included details about data and sample collection procedures.
• Accelerate development of study monitory plan which brought about regulatory and operation harmony within the company • Create and revise operation manuals • Arrange agendas and logistics for annual training • Monitor enrolling site performance for subject accession • Review reports for publication