September 11, 2022 at 10:12 am #4730
Does anyone have experience archiving subject questionnaires (not templates,but including subjects’ answers)?
We have corrected subject opinions about the sponsor’s materials, such as eICF for our decentralized clinical trial.
I wasn’t sure if there were any recommendations to upload them to eTMF as a study document.
September 14, 2022 at 9:44 pm #4733
That depends on where in the process you have done the questionnaire and what you intent and/or are doing with the answers.
1. Is it pre or post site activation and/or enrollment?
2. Do you amend the study specific patient material based on the answers?
September 16, 2022 at 11:32 am #4734
Thank you for responding to my question.
We are discussing the way to manage patient centric related documents, for sponsors’ responsibility for patient-centric operations is increasing.
Could you enlighten me on the basic idea how to categorize and keep the documents?
1. It happened pre site activation and enrollment.
We collected the questionnaire from patient advocacy group members.
2. We plan to fix the study specific patient material version1 based on the answers.
Perhaps we might take other questionnaires after site activations and enrollments by asking the subjects of the study, and amend the patient material in the future.
September 19, 2022 at 6:00 pm #4736
First, the core purpose of a TMF is to document GCP compliance, so only document content that are for GCP compliance. In traditional trials there have been specific artifacts to document compliance, whereas newer trial designs, such as DCT’s are reliant on risk management to ensure and document GCP compliance.
So, what I would do is to start with documenting the identified risks in artifact 01.01.16 – Risk Management Plan and based on that include the plan for mitigations in artifact 01.01.02 – Trial Management Plan, where you can document what you intent to do and that you have done it.
The actual material be documented in a risk log (sub-artifact) under artifact 01.01.16 – Risk Management Plan. You could also document this under 01.05.02 – Tracking Information and 01.05.03 – Other Meeting Material.
I like to keep related content together in one artifact in this case artifact 01.01.16 – Risk Management Plan, but it all comes down to you being able to answer inspectors questions the best when you need to.
September 19, 2022 at 8:24 pm #4737
This TransCelerate documentation may help you.
Patient Protocol Engagement Toolkit (P-PET) Quick Start Video
September 21, 2022 at 12:36 am #4742
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