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Part 11: Predicate Documents

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Guest
#1 · February 27, 2023, 9:18 pm
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Part 11 guidance states only documents listed in predicate rule are subject to Part 11.

Predicate rule for drugs (21 CFR 312.53 "Selecting investigators and monitors") Lists these documents explicitly:

1. 1572

2. Protocol

3. Investigator commitment to IRB

4. PI CV

5. *List of names of subinvestigators (e.g., research fellows, residents) assisting the investigator in the conduct of the investigation.

As 5, above, describes only a list of names, if a list of names with sites staff can be provided, then a sponsor's delegation of authority log is not subject to the Predicate rules for Part 11?

Thus, could use DocuSign if there was a process in place describing its use and its controls and avoid all the deep systems validation we're exposed to by Part 11?

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brad@brad
184 Posts
#2 · February 28, 2023, 2:54 pm
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I mean, this checks out to me. Are you a site?

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Hightower Clinical / Note to File Podcast / Existential Dilettante / "Specialization is for insects"
Guest
#3 · March 2, 2023, 4:19 am
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Quote from brad on February 28, 2023, 2:54 pm

I mean, this checks out to me. Are you a site?

Nope, site at an institution.

(Read: Part 11 compliant SOP needs to go through a lot of approvals. Exploring something I can deploy quickly without risking a heavy ding)

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Guest
#4 · March 2, 2023, 4:21 am
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Quote from Guest on March 2, 2023, 4:19 am
Quote from brad on February 28, 2023, 2:54 pm

I mean, this checks out to me. Are you a site?

Edit: YES, site at an institution.

(Read: Part 11 compliant SOP needs to go through a lot of approvals. Exploring something I can deploy quickly without risking a heavy ding)

 

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