"Study File Notebook"

Study file notebook including protocol, study flow sheet, general questionnaire and forms examples, copy of ethics application form, ethics correspondence, patient log, general correspondence, site visit feedback, adverse event details/hospital reports, patient information sheets, pharmaceutical administration, study pharmacy manuals, Remicade summary product characteristics, study staff cvs, patient recruitment posters, correspondence and study indemnification agreement.

Please note that many of the papers contained in the study file notebook feature KIR 2000 year one, two and threel papers (SA/KET/A/1/8/1-SA/KET/A/1/8/3).

2000-2003

1 file (in 3 parts)

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