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Policies & Procedures

 
Policy Document Effective Date
RS-01
WellStar Research Institute Policies and Procedures

June 2018

RS-02
Conduct of Clinical Research

June 2018

RS-03
Protection of Human Research Subjects

June 2018

RS-04
Conflicts of Interest in Research

June 2018

RS-04-01
Elements for FCOI Report

June 2018

RS-04-02
Managment Plan

June 2018

RS-04-03
Retrospective Review

June 2018

RS-05
Initial Review of Research

June 2018

RS-05-01
Request for Non-Human Subjects-Research-Determination

June 2018

RS-05-02
Request for Exempt Research Determination

June 2018

RS-05-03
Request for Initial Review by Expedited Procedure

June 2018

RS-06
Contract with Sponsors/CROs

August 2018

RS-07
Defining Human Research

June 2018

RS-08
Independent Student Research Projects

June 2018

RS-09
IND, IDE, HDE/HUD

June 2018

RS-10
Regulatory Files and Subject Records

June 2018

RS-11
Informed Consent and Authorization to Use and Disclose Protected Health Information

June 2018

RS-12
Unanticipated Problems and Serious Adverse Events

June 2018

RS-12-01
Serious Adverse Event Worksheet

June 2018

RS-13
Institutional Review Board Policies and Procedures

June 2018

RS-14
Protocol Deviations

June 2018

RS-14-01
Protocol Deviation Worksheet

June 2018

RS-15
Special or Vunerable Populations

June 2018

RS-16
Responsiblities of the Principal Investigator and Research Team

June 2018

RS-17
Training and Education

June 2018

RS-18
Subject Recruitment and Screening

June 2018

RS-19
Compensation to Research Subjects

June 2018

RS-20
Access to Clinical Trials

June 2018

RS-21
Investigational Product Accountability, Storage, Dispensing, Transport and Return

June 2018

RS-22
Emergency Use of an Investigational Product

June 2018

RS-23
Visits to the Site by the Sponsor/CRO

June 2018

RS-24
Audits by Sponsors or Regulatory Agencies

June 2018

RS-25
Data Managment

June 2018

RS-26
Quality and Process Improvement Program

June 2018

RS-27
Data and Safety Monitoring

June 2018

RS-28
Research Non-Compliance

June 2018

RS-29
Research Misconduct

June 2018