Where do I file a Protocol Deviation Guideline?

[Nick Hryciw ('her issue')]

For our studies, we have implemented the Protocol Deviations Guidelines for CRAs to follow when entering PDs into our CTMS. We also have a Protocol Deviation Flowchart which outlines the activities related to PDs, from entering into CTMS to medical monitor review, and classification as major or minor. Where would I file these trial level documents in the eTMF for reference 3.2.0?

[Eldin Rammell]

Hi Nick

Is this a trial-specific guideline?

[Nick Hryciw ('her issue')]

Hi Eldin,

Excellent question — it is not a trial specific guideline but used across all of our programs. Should it not be filed in the TMF or should it be filed in our TMF for each study?

[Janna Gonzalez]

Hi Nick,

I think it should be filed in TMF for each study.

This is a Study Level document across all studies correct?

Example of documents,
“Acknowledgement of Receipt Protocol Deviation Listing (component of CSR)
Protocol Deviation Report
Waiver Report
Deviation date
PI Signature Date
CRA Signature Date
CM Signature Date”

05 Site Management 05.04 Site Management 05.04.06 Protocol Deviations To document non-compliance/ deviations to the protocol. This may also be a consolidated list for a country filed at the country level or a consolidated list for the study filed at the study level. “Protocol Deviations
Protocol Deviation Logs
Protocol Deviation Report
”
Hope this helps!
Janna

[Vaibhav Funde]

Protocol Deviations Guidelines for CRAs if this document is created specifically for training purpose of CRAs then we can use artifact “01.04.02 – Trial Team Training Material”.

[Nick Hryciw ('her issue')]

Thank you everyone and I am so sorry for my late reply. I have been so busy, I forgot I posted the question. I do think it might be best filed in artifact 01.04.02 as it is a guideline for all of our studies to inform CRAs how to enter PDs in our CTMS. It is not a report or a listing of actual PDs.

[Qiutao Yu]

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 6 months ago by Qiutao Yu.
• This reply was modified 6 months ago by Qiutao Yu.

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