SOP INDEX Administrative Study Management Regulatory Quality Assurance Unit Data Management   Administrative SOP #                               TITLE                         SOP LAST UPDATED ADM-101 Compliance with FDA Regulations and ICH-GCP Guidelines 06/14/2007 ADM-102 Development and Implementation of SOPs    01/09/2007 ADM-103  Responsibilities of the Principal Investigator    06/14/2007 ADM-104  Responsibilities of the Sponsor-Investigator     ADM-105  Coordinator of Clinical Trials Agreements    02/15/2008 ADM-106  Preparing and Managing Study Budgets    01/31/2008 ADM-107   Accessing Study Funding for Patient Remuneration    06/14/2007  ADM-108  Protocol Risk Assessment      ADM-109  Training and Education    06/14/2007 Back to Top    Study Management SOP #                         TITLE                         SOP LAST UPDATED  SMG-101  Study Set-up Sponsor Projects    01/05/2007  SMG-102  Study Set-up Investigator Initiated Projects    01/05/2007  SMG-103  Development of Informed Consent    01/05/2007  SMG-104  Site Initiation     02/15/2008  SMG-105  Review of Patient Diagnostic and Laboratory Testing    09/17/2007  SMG-106v2  Recruitment of Study Subjects    09/17/2007  SMG-107  Study Drug Accountability     02/15/2008  SMG-108  Approval of Subjects for Study Participation    09/17/2007  SMG-109  Medication Admin     02/15/2008  SMG-110  Ordering of Safety Labs      SMG-111  Sample Collection    09/17/2007  SMG-112  Sample Management    09/17/2007 SMG-113   Adverse Event and Serious Adverse Event Reporting    06/14/2007  SMG-114  Equipment Maintenance     02/15/2008  SMG-115  Study Close-Out    09/17/2007 Back to Top    Regulatory SOP #                          TITLE                         SOP LAST UPDATED  REG-101  Regulatory Binder    01/05/2007  REG-102 IRB Communications for Clinical Research Studies    01/05/2007  REG-103 Completion of Form FDA 1572    09/17/2007  REG-104 Communication with the Study Sponsor    09/17/2007  REG-105 Filing IND Safety Updates to the IRB    01/09/2007  REG-106 Delegation of Responsibility    09/17/2007 Back to Top    Quality Assurance Unit SOP #                               TITLE                         SOP LAST UPDATED QAU-101  Monitoring Visits                                                     06/14/2007 Back to Top    Data Management SOP #                               TITLE                         SOP LAST UPDATED DM-102  Case Report Form Completion                                06/14/2007 Back to Top