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The package insert includes details and directions that health care providers need to prescribe a drug properly, including approved uses for the drug, contraindications, potential adverse reactions, available formulations, and dosage, and how to administer the drug.
IP Instructions: storage and dispensing of IP. Instruction on return of unused IP; Establishing Quality control for IP. The procedures should address adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from subjects, and return of unused investigational product(s) to the sponsor (or alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory requirement(s))
both are part of the IP process but two separate processes and are filed separately
IRB or IEC Trial Approval 04.01.03 IRB or IEC Composition IRB or IEC Composition 04.01.03 IRB or IEC Composition X X Version Version date Documentation that the IRB/IEC consists of a reasonable number of members who collectively have the qualifications and experience to review and evaluate the science, medical aspects and ethics of the proposed trial.
Trial Committee 01.03.03 Committee Output “DSMB Output
DMC Output
Data Adjudication Output
Steering Committee Output
Dose Escalation Output
Device Output
Committee Output: Other” 01.03.03 Committee Output X Version Version date To document any agreements or significant decisions regarding trial conduct, protocol violations, adverse event reporting, to include minutes, reports, notifications, recommendations from a Trial Committee. Can be applicable to interim and final analyses.
This is our filing sections according to our reference model filingsHi Debra, I would advise you to QC emails before submitting to the eTMF. this way only study related clean emails will be in the eTMF and you/your team will not have to cleanup the communication section at the end of the study and you will be audit ready at all times. I hope this helps
RegardsAre you maintaining paper and electronic documents. If it is electronic and have been validated thru the eTMF systems then the original documents should not be filed unless you are maintaining both paper and electronic documents. However, Please review your SOPs/TMF plan regarding this process on how to manage or return wet ink documents if you are not the sponsor. If you are the sponsor, you would follow your company/department SOPs regarding filing of wet ink documents. Thanks
So you would file your documents receive within the other committee submissions or approvals. sections 4.1 and 4.2. accordingly.
Regards
Will these documents be filed under trial level or site/country level, That will basically determine which committee it will be filed under.
Will these documents be filed under trial level or site level, That will basically determine which committee it will be filed under.
Yes, still under the IRB section and filed in other committee as you would a local IRB
IRB or IEC and other Approvals 04.02 Other Committees 04.02.02 Other Approvals “Scientific Committee Approval
Institutional Committee Approval
Veterans Affair Committee Approval
Radiation Committee Approval
Financial Committee Approval
Data Protection Committee Approval
Biobank Committee Approval
Other Approvals: Other” 04.02.02 Other Approvals X X Approval dateI would think you could still file the documents under the IRB/IEC section
because I believe IBC functions as a oversight, compliance and approval with members function in the same capacity as the major IRBs or Local IRBs (more local than central IRBs) as long as there members approval schedules You would file them as a local IRB. Below are some requirements of an IBC at UNC Hospital. I hope this helpsFunction of the IBC
The IBC is responsible for the oversight, administration, and review of UNC‐CH Lab policies and projects involving research with recombinant or synthetic nucleic acid molecules and hazardous biological materials that may pose safety, health, or environmental risks. To this end, the IBC assists and advises Principal Investigators and other researchers in meeting their responsibilities to ensure that the biological aspects of the research are conducted in a safe manner using established biosafety standards, principles and work authorization. Safe research includes worker safety, public health, agricultural and environmental protection, ethics, and compliance with applicable biosafety standards and UNC‐CH Policies.The IBC will investigate and report any significant problems with or violations of the NIH Guidelines and any significant research‐related accidents or illnesses involving recombinant genomic materials to the Principal Investigator, the Biological Safety Officer, the Department Chair, and the NIH Office of Biotechnology Activities (OBA) within 30 days, unless the IBC determines that the Principal Investigator or lead researcher has already filed a report.
Structure of the IBC
A broad array of available research and regulatory expertise is important for the IBC given the range of recombinant DNA research that the committee reviews. The NIH requires that the IBC have at least five members selected who collectively have the experience, expertise, and capability needed to assess the breadth and safety of recombinant and synthetic nucleic acid molecules as well as other biological materials, agents, and organisms as needed to identify any potential risks to workers, public health, or the environment.IBC Charter Approval
IBC members will review proposed amendments to this charter during a regularly scheduled meeting of the committee and vote on acceptance of each amendment.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 FilenoteRita it’s not the norm since I’ve been in the business, however, this listing is constantly updated until final selection has been completed. I would maintain it on a shared drive or a folder on your desk top. Unless requested by upper management to file it in the TMF. However it is not a required document to be filed at trial or country level. I hope this helps