Reply To: IP Related Docs

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#2766
Karen Williams
Participant

Most IP documentation are site related documents related to the study trial. The documents you are speaking about or mainly kept in lab manuals. Unless specified by the sponsor to file in the central file section.

Below are the area we file site submitted IP documents:
06.01.02 IP Instructions for Handling IP Instructions for Handling 06.01.02 IP Instructions for Handling
06.01.03 IP Sample Label IP Sample Label 06.01.03 IP Sample Label
06.01.04 IP Shipment Documentation “IP Shipment Pro Forma Invoice
Packaging Order
Shipment Request Form
Approval to Ship
Acknowledgement of Receipt
IP Shipment Documentation: Other” 06.01.04 IP Shipment Documentation
06.01.05 IP Accountability Documentation IP Accountability Documentation 06.01.05 IP Accountability Documentation
06.01.06 IP Transfer Documentation IP Transfer Documentation 06.01.06 IP Transfer Documentation
06.01.07 IP Re-labeling Documentation IP Re-labeling Documentation 06.01.07 IP Re-labeling Documentation
06.01.08 IP Recall Documentation IP Recall Documentation 06.01.08 IP Recall Documentation
06.01.09 IP Quality Complaint Form IP Quality Complaint Form 06.01.09 IP Quality Complaint Form
06.01.10 IP Return Documentation IP Return Documentation 06.01.10 IP Return Documentation
06.01.11 IP Certificate of Destruction 06.01.11 IP Certificate of Destruction
06.01.12 IP Retest and Expiry Documentation IP Retest and Expiry Documentation 06.01.12 IP Retest and Expiry Documentation
06.02.01 QP (Qualified Person) Certification QP (Qualified Person) Certification 06.02.01 QP (Qualified Person) Certification
06.02.02 IP Regulatory Release Documentation IP Regulatory Release Documentation 06.02.02 IP Regulatory Release Documentation
06.02.03 IP Verification Statements IP Verification Statements 06.02.03 IP Verification Statements
06.02.04 Certificate of Analysis Certificate of Analysis 06.02.04 Certificate of Analysis
06.03.02 IP Unblinding Plan IP Unblinding Plan 06.03.02 IP Unblinding Plan
06.04.01 IP Storage Condition Documentation IP Storage Condition Documentation 06.04.01 IP Storage Condition Documentation
06.04.02 IP Storage Condition Excursion Documentation IP Storage Condition Excursion Documentation 06.04.02 IP Storage Condition Excursion Documentation
06.04.03 Maintenance Logs (Device) Maintenance Logs (Device) 06.04.03 Maintenance Logs (Device)
06.05.01 Non-IP Supply Plan Non-IP Supply Plan 06.05.01 Non-IP Supply Plan
06.05.02 Non-IP Shipment Documentation Non-IP Shipment Documentation 06.05.02 Non-IP Shipment Documentation
06.05.03 Non-IP Return Documentation Non-IP Return Documentation 06.05.03 Non-IP Return Documentation
06.06.01 IRT User Requirement Specification IRT User Requirement Specification 06.06.01 IRT User Requirement Specification
06.06.02 IRT Validation Certification IRT Validation Certification 06.06.02 IRT Validation Certification
06.06.03 IRT User Acceptance Testing (UAT) Certification IRT User Acceptance Testing (UAT) Certification 06.06.03 IRT User Acceptance Testing (UAT) Certification
06.06.04 IRT User Manual IRT User Manual 06.06.04 IRT User Manual
06.06.05 IRT User Account Management IRT User Account Management 06.06.05 IRT User Account Management
06.07.01 Relevant Communications IP and Trial Supplies Relevant Communications 06.07.01 Relevant Communications
06.07.02 Tracking Information IP and Trial Supplies Tracking Information 06.07.02 Tracking Information
06.07.03 Meeting Material “IP and Trial Supplies Agenda
IP and Trial Supplies Minutes
IP and Trial Supplies Presentation Materials
IP and Trial Supplies Questions and Answers
IP and Trial Supplies Meeting Material: Other”
06.07.03 Meeting Material
06.07.04 Filenote IP and Trial Supplies Filenote 06.07.04 Filenote