PMA-Regulatory Submission - SAS Statistics Finance and Others - SvipBook-CFA FRM AICPA SAS Finance Study Material
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PMA-Regulatory Submission

专业知识材料,知者自知
Include
consentQC tool
CTU 001-02 ICF process final
CTU 002-02 Source Docs
CTU 003-02 essential-doc
CTU 004-02 Office Chart
CTU 005-02 Study Visits-and Missed Visits
CTU 006-01 Study Mediciations
CTU 007-02 Toxicity Management AE-SAE Reporting
CTU 008-01 Subject Recruitment
CTU 010-01 subject logs and codes
CTU 012-01 Transportation reimbursement
CTU-009-01 protocol implementation
KCMC  QM Feb2007
KCMC IEC submission Checklist v4
KCMC New Protocol Evaluation Survey
KCMC Orientation Manual
Module C ACTG Research Coordinator
Module D PVT Study Nurse CBO
Monitoring visits SOP
oriention research coordinator
REG 001-01 KCMC Regulatory Affairs
Signature Page
Site Assessment
Site Responsibility Log
SOP SID PID
SOP-General Operating Procedure for Essential Regulatory Documents 2005KCMC
SOP-location essential documents 2006 S005.1
SOP-SafetyReports 2006 S006.1
SOP-Submissions 2006 S007.1
subject log
THIRST Delegation Log
Training record
Venipuncture SOP

Mediafire Link
http://www.mediafire.com/downloa ... atorySubmission.rar

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