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Guidance Documents

 


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Administrative     Study Management     Regulatory     Quality Assurance Unit     Data Management

Administrative

 Guidance Document No.

                             Title                      

Last Updated

ADM-101

Compliance with Good Clinical Practice

01 Oct 2009

ADM-102

Guidance Document Regulations

01 Oct 2009

ADM-103

 Responsibilities of the Principal Investigator

01 Oct 2009

ADM-104

 Preparing and Managing Study Budgets

01 Oct 2009

ADM-105

 Accessing Study Funding for Patient Remuneration

01 Oct 2009

ADM-106

 Training and Education

01 Oct 2009

ADM-107 

 Tenet Patient Chart Access

01 Oct 2009

 ADM-108

 Industry Sponsored Contracts

01 Oct 2009

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Study Management

Guidance Document No.

                       Title                      

Last Updated
 SMG-101  Study Set-up Sponsor Projects

01 Oct 2009
 SMG-102  Study Set-up Investigator Initiated Projects

01 Oct 2009
 SMG-103  Development of Informed Consent

01 Oct 2009
 SMG-104  Site Initiation

01 Oct 2009
 SMG-105  Review of Patient Diagnostic and Laboratory Testing

01 Oct 2009
 SMG-106  Recruitment of Research Subjects

01 Oct 2009
 SMG-107  Study Drug Accountability

01 Oct 2009
 SMG-108  Approval of Subjects for Study Participation

01 Oct 2009
 SMG-109  Medication Administration

01 Oct 2009
 SMG-110  Sample Collection

01 Oct 2009
 SMG-111  Sample Management

01 Oct 2009
SMG-112  Adverse Event and Serious Adverse Event Reporting

01 Oct 2009
 SMG-113  Equipment Maintenance

01 Oct 2009
 SMG-114  Study Close-Out

01 Oct 2009

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Regulatory

Guidance Document No.

                        Title                      

Last Update
 REG-101  Maintenance of Investigator Study File

01 Oct 2009
 REG-102 IRB Communications for Clinical Research Studies

01 Oct 2009
 REG-103 Completion of Form FDA 1572

01 Oct 2009
 REG-104 Communication with the Study Sponsor

01 Oct 2009
 REG-105 Filing IND Safety Updates to the IRB

01 Oct 2009
 REG-106 Delegation of Responsibility

01 Oct 2009

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Quality Assurance Unit

Guidance Document No.

                             Title                      

Last Updated
QAU-101  Monitoring Visits                                                 

01 Oct 2009
QAU-102 External Audit or Inspection

01 Oct 2009

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Data Management

Guidance Document No.

                             Title                      

Last Updated
DM-101  Source Documentation                                       

01 Oct 2009
DM-102 Case Report Form Completion

01 Oct 2009

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