Forum Replies Created

Viewing 7 posts - 1 through 7 (of 7 total)
  • Author
    Posts
  • Qiutao Yu
    Participant

    We create a tool called “CO SOP list” at CO which can be used for study teams to start with to generate their study specific SOP list. However, we’re also struggling on a few points below:
    a. Do company level general SOPs applying for all employees should be listed? E.g. Quality policy, quality manual?
    b. We might be able to ensure for all SOPs owned by CO/Medical/PV/Drug Supply (which are crucial to clinical study operations) to be covered and up-to-date, but not able to cover SOPs that applying for/coming from all cross-functions, e.g., should their applicable SOPs be included as well?
    c. We’re sure that if there’re outsourced services but adopting our internal process, then relevant SOPs should be listed as for contractors’ training requirements, but how about fully in-house studies? Is it necessary cuz all the members will receive the standard SOP trainings?

    • This reply was modified 1 year ago by Qiutao Yu.
    in reply to: IP Related Docs #4987
    Qiutao Yu
    Participant

    We’re also confusing on this. But thank to Kathie’s inspiring reply. They’re most helpful.

    in reply to: File documents with tracked changes? #4985
    Qiutao Yu
    Participant

    We file them (CSR/IB/MICF tracking versions) in Regulatory binder, but not repeatedly file into study eTMF as the 2 repositories working for different purposes/functions. In my view, Study eTMF cannot be exclusive for all regulatory required documents. For example, some compound level of documents generated from CMC/GMP.

    • This reply was modified 1 year ago by Qiutao Yu.
    in reply to: Decentralized Trials – Raw Data #4984
    Qiutao Yu
    Participant

    In 2021 WHO ECSPP 55th Report _ Annex 4 Guideline on data integrity, Raw data is equal to Source data. So from my view, they must be retained if the data (composing into the “Summary”) are critical.

    in reply to: Electronic signatures in paper TMF #4983
    Qiutao Yu
    Participant

    You know I once faced a document with 4 types of “sigantures” from all the document contributors:
    1. Signed in Wet-ink
    2. Signed by Adobe
    3. DocSign
    4. The eSignature workflow configured in the study eTMF system.

    I don’t know how to put this. Maybe every signature took individually is validated, but 4 in 1 document, I’d doubt it

    in reply to: What Type of Documents Need to be Certified When eFiling? #4981
    Qiutao Yu
    Participant

    EMA Guideline: Guideline on the content, management and archiving of TMF_6Dec2018 section 5 has provided clear instructions on this.

    For the follow up question, my personal thinking is that it could be acceptable as long as the process is “validated”. For example, set a series of Criteria for risk-based QC:

    1. Documents that are essential per ICH GCP 8 should be 100% QCed
    2. A certain percentage of other non-essential documents to be verified. If errors, then should expand the scope/volume of documents to be checked.

    • This reply was modified 1 year ago by Qiutao Yu.
    in reply to: Where do I file a Protocol Deviation Guideline? #4978
    Qiutao Yu
    Participant

    Just sharing my experience here:
    This type of documents are named as “CTMS/ETMF Job-Aids” in our knowledge management framework, apart from “PD Guideline”, we have “How to write a MVR in CTMS”, “How to create an Action (Follow-up) Item” etc., these are taken similarly to company level SOPs, and we don’t ask teams to file into their study eTMF respectively. However, they can if they want, add these “References” into their SOP/Training List for indexing as a summary.

    What should be filed, it’s study specifications of PD Handling Plan, like PD classifications, PD Review Process etc., under T01 Trial Management.

    • This reply was modified 1 year ago by Qiutao Yu.
    • This reply was modified 1 year ago by Qiutao Yu.
Viewing 7 posts - 1 through 7 (of 7 total)