SOP Master List – Artifact: 01.01.04 – List of SOPs Current During the Trial

[Daniella Chambers]

Hi,
I am putting together a Work Instruction around how to create at my company a Study SOP Master List to be filed in our TMF. I would like to hear how this process is done and if you have any good ways for creation of the list and updates throughout the trial. Any help is very much appreciated.

[Purna Cheekati]

I am interested to find what are all the SOP’s do we need for eTMF?

[Janna Gonzalez]

Hi Both,

In my last job.
My Company did not file site-specific SOPs in the sponsor TMF. They should remain at the site and be available upon request as part of site selection, or during an audit or an inspection. Other organizations, maintain one TMF set Per site to maintain site-level documents, so we could technically place the site-specifics SOPs within 01.01.04 if situation arises.

Your organization should have a SOP for preparation and maintenance for TMF.

hope this helps!
Janna

[Qiutao Yu]

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 2 months, 2 weeks ago by Qiutao Yu.

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