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Guidance Documents

 

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Administrative     Study Management     Regulatory     Data Management

Administrative

Guidance Document No.   Title  Last Updated
ADM-101                                      Compliance with Good Clinical Practice                                      15 Mar 2013         
ADM-102 Guidance Document Regulations  15 Mar 2013
ADM-103 Responsibilities of the Principal Investigator  15 Mar 2013
ADM-104 Preparing and Managing Study Budgets  15 Mar 2013
ADM-105 Accessing Study Funding for Patient Remuneration  15 Mar 2013
ADM-106 Training and Education  15 Mar 2013
ADM-107 Tenet Patient Chart Access  15 Mar 2013
ADM-108 Industry Sponsored Contracts  15 Mar 2013

Study Management

Guidance Document No.   Title  Last Updated
SMG-101                                      Compliance with Good Clinical Practice                                      15 Mar 2013         
SMG-102 Guidance Document Regulations  15 Mar 2013
SMG-103 Responsibilities of the Principal Investigator  15 Mar 2013
SMG-104 Preparing and Managing Study Budgets  15 Mar 2013
SMG-105 Accessing Study Funding for Patient Remuneration  15 Mar 2013
SMG-106 Training and Education  15 Mar 2013
SMG-107 Tenet Patient Chart Access  15 Mar 2013
SMG-108 Industry Sponsored Contracts  15 Mar 2013
SMG-109  Investigational Product Administration  15 Mar 2013
SMG-110  Sample Collection  15 Mar 2013
SMG-111  Sample Management  15 Mar 2013
SMG-112  Adverse Event and Serious Adverse Event Reporting  15 Mar 2013
SMG-114  Study Close-Out  15 Mar 2013
SMG-115  Study Drug Transport  15 Mar 2013

Regulatory

Guidance Document No.   Title  Last Updated
 REG-101                                       Maintenance of Investigator Study File                                           15 Mar 2013         
 REG-102  IRB Communications for Clinical Research Studies  15 Mar 2013
 REG-103  Completion of Form FDA 1572  15 Mar 2013
 REG-104  Communication with the Study Sponsor  15 Mar 2013
 REG-105  Filing IND Safety Updates to the IRB  15 Mar 2013
 REG-106  Delegation of Responsibility  15 Mar 2013
 REG-107  Process for Obtaining Subjects` Consent  15 Mar 2013

Data Management

Guidance Document No.  Title Last Updated
 DM-101                                         Source Documentation                                                                     15 Mar 2013          
 DM-102  Case Report Form Completion  15 Mar 2013

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