Karen Williams

Forum Replies Created

Viewing 11 posts - 1 through 11 (of 11 total)
  • Author
    Posts
  • in reply to: Filing DSMB Reports and IRB Committee Member’s List? #2835
    Karen Williams
    Participant

    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 filings

    in reply to: Relevant Communication #2822
    Karen Williams
    Participant

    Hi 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
    Regards

    in reply to: Best Practice: Wet-Ink Signatures & Certified Copies #2816
    Karen Williams
    Participant

    You are welcome.
    Regards

    in reply to: Best Practice: Wet-Ink Signatures & Certified Copies #2814
    Karen Williams
    Participant

    Are 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

    in reply to: IBC TMF Filing #2802
    Karen Williams
    Participant

    So you would file your documents receive within the other committee submissions or approvals. sections 4.1 and 4.2. accordingly.

    Regards

    in reply to: IBC TMF Filing #2800
    Karen Williams
    Participant

    Will these documents be filed under trial level or site/country level, That will basically determine which committee it will be filed under.

    in reply to: IBC TMF Filing #2799
    Karen Williams
    Participant

    Will these documents be filed under trial level or site level, That will basically determine which committee it will be filed under.

    in reply to: IBC TMF Filing #2798
    Karen Williams
    Participant

    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 date

    in reply to: IBC TMF Filing #2796
    Karen Williams
    Participant

    I 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 helps

    Function 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.

    in reply to: IP Related Docs #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

    in reply to: Does the Investigator List get filed in the TMF? #2745
    Karen Williams
    Participant

    Rita 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

Viewing 11 posts - 1 through 11 (of 11 total)