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Pharmaceutical industry / Health / Medical statistics / Orthopedic surgery / Food and Drug Administration / Hip replacement / Clinical trial / Investigational Device Exemption / Clinical investigator / Clinical research / Research / Medicine


Microsoft Word - 0F Clinical Technical Section NEW v0.docx
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City

Warsaw / /

Company

DePuy / Clinical Research Department DePuy Orthopaedics Inc. / Johnson & Johnson / /

Event

Product Issues / Product Recall / /

IndustryTerm

metal liner / ceramic and metal bearing / metal total hip prosthesis / investigational site / respective investigational site / healthcare providers / control / study protocol / metal acetabular liner / /

MedicalCondition

primary noninflammatory degenerative joint disease / /

MedicalTreatment

hip replacement / Total Joint Replacement / clinical protocol / /

Movie

Range of Motion / /

Organization

FDA / Institutional Review Board / Contract Research Organization / American Society for Testing Materials / U.S. Food and Drug Administration / /

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Position

INVESTIGATOR / Clinical Investigator / INTRA-OPERATIVE / Exclusion Criteria Obtain Subject History CRF Complete Subject Evaluation Complete Harris Hip Form Operative / metal femoral head / ceramic femoral head / /

Product

FOLLOW-UP SCHEDULE SUBJECT / New Medications / /

ProvinceOrState

Indiana / /

Technology

X-ray / detailed study protocol / 5 6 6.1 6.2 7 7.1 7.2 7.3 Item Protocol / /

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