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Quote from User123 on August 16, 2022, 1:28 pmHi. This is a question addressed to sites who use EHR for source documents and been asked to provide documentation for such.
Is the site’s EMR system compliant with Good Clinical Practice regulations (e.g. 21 CFR Part 11) for EMR systems?
There is a guidance document from FDA but it is confusing. Please share your expertise here. Thanks!
Hi. This is a question addressed to sites who use EHR for source documents and been asked to provide documentation for such.
Is the site’s EMR system compliant with Good Clinical Practice regulations (e.g. 21 CFR Part 11) for EMR systems?
There is a guidance document from FDA but it is confusing. Please share your expertise here. Thanks!
Quote from Guest on February 27, 2023, 9:02 pmThe FDA states, "it is not their intent to monitor electronic health records for compliance."
As an example, Epic issues a document stating they meet the rigorous ONC requirements, points to the FDAs statement, and institutions often leverage this with a notice stating, "because of this, we use Epic for source".
The FDA states, "it is not their intent to monitor electronic health records for compliance."
As an example, Epic issues a document stating they meet the rigorous ONC requirements, points to the FDAs statement, and institutions often leverage this with a notice stating, "because of this, we use Epic for source".
Quote from Guest on July 26, 2023, 8:00 pmYou need to demonstrate that your system can meet the attributes of ALCOA plus. Is it attributable who made the entry and when, who changed the entry (if applicable), can you see the original and updated entry (audit trail), is access managed and not shared (password enforcement), etc. If not, then the FDA can cite you for not having adequate source documentation which comes straight from 21 CFR Part 312.
You need to demonstrate that your system can meet the attributes of ALCOA plus. Is it attributable who made the entry and when, who changed the entry (if applicable), can you see the original and updated entry (audit trail), is access managed and not shared (password enforcement), etc. If not, then the FDA can cite you for not having adequate source documentation which comes straight from 21 CFR Part 312.
Quote from Guest on August 3, 2023, 5:09 pmQuote from Guest on July 26, 2023, 8:00 pmYou need to demonstrate that your system can meet the attributes of ALCOA plus. Is it attributable who made the entry and when, who changed the entry (if applicable), can you see the original and updated entry (audit trail), is access managed and not shared (password enforcement), etc. If not, then the FDA can cite you for not having adequate source documentation which comes straight from 21 CFR Part 312.
Pretty much this.
Funny enough, i have a suspicion this was a big one in the whole "trials in a van" thing we recently saw. An esource that had audit trails and all was used, so every section had a little indicator saying which user filled it out. Then at some point came the request to confirm in a freeform comment section who is the person entering the source info. Kinda like the audit trail whodunnit indicator could be telling porky-pies. Go figure
Quote from Guest on July 26, 2023, 8:00 pmYou need to demonstrate that your system can meet the attributes of ALCOA plus. Is it attributable who made the entry and when, who changed the entry (if applicable), can you see the original and updated entry (audit trail), is access managed and not shared (password enforcement), etc. If not, then the FDA can cite you for not having adequate source documentation which comes straight from 21 CFR Part 312.
Pretty much this.
Funny enough, i have a suspicion this was a big one in the whole "trials in a van" thing we recently saw. An esource that had audit trails and all was used, so every section had a little indicator saying which user filled it out. Then at some point came the request to confirm in a freeform comment section who is the person entering the source info. Kinda like the audit trail whodunnit indicator could be telling porky-pies. Go figure
Quote from brad on August 3, 2023, 5:42 pmQuote from Guest on August 3, 2023, 5:09 pmQuote from Guest on July 26, 2023, 8:00 pmYou need to demonstrate that your system can meet the attributes of ALCOA plus. Is it attributable who made the entry and when, who changed the entry (if applicable), can you see the original and updated entry (audit trail), is access managed and not shared (password enforcement), etc. If not, then the FDA can cite you for not having adequate source documentation which comes straight from 21 CFR Part 312.
Pretty much this.
Funny enough, i have a suspicion this was a big one in the whole "trials in a van" thing we recently saw. An esource that had audit trails and all was used, so every section had a little indicator saying which user filled it out. Then at some point came the request to confirm in a freeform comment section who is the person entering the source info. Kinda like the audit trail whodunnit indicator could be telling porky-pies. Go figure
can you elaborate on this? are you saying there was an audit trail built in and then a freeform comment box to indicate who entered source and those two sources didn't jive?
why would you need the comment box if there was already an audit trail? am i missing something here?
Quote from Guest on August 3, 2023, 5:09 pmQuote from Guest on July 26, 2023, 8:00 pmYou need to demonstrate that your system can meet the attributes of ALCOA plus. Is it attributable who made the entry and when, who changed the entry (if applicable), can you see the original and updated entry (audit trail), is access managed and not shared (password enforcement), etc. If not, then the FDA can cite you for not having adequate source documentation which comes straight from 21 CFR Part 312.
Pretty much this.
Funny enough, i have a suspicion this was a big one in the whole "trials in a van" thing we recently saw. An esource that had audit trails and all was used, so every section had a little indicator saying which user filled it out. Then at some point came the request to confirm in a freeform comment section who is the person entering the source info. Kinda like the audit trail whodunnit indicator could be telling porky-pies. Go figure
can you elaborate on this? are you saying there was an audit trail built in and then a freeform comment box to indicate who entered source and those two sources didn't jive?
why would you need the comment box if there was already an audit trail? am i missing something here?
Quote from Guest on August 6, 2023, 6:50 amQuote from brad on August 3, 2023, 5:42 pmQuote from Guest on August 3, 2023, 5:09 pmQuote from Guest on July 26, 2023, 8:00 pmYou need to demonstrate that your system can meet the attributes of ALCOA plus. Is it attributable who made the entry and when, who changed the entry (if applicable), can you see the original and updated entry (audit trail), is access managed and not shared (password enforcement), etc. If not, then the FDA can cite you for not having adequate source documentation which comes straight from 21 CFR Part 312.
Pretty much this.
Funny enough, i have a suspicion this was a big one in the whole "trials in a van" thing we recently saw. An esource that had audit trails and all was used, so every section had a little indicator saying which user filled it out. Then at some point came the request to confirm in a freeform comment section who is the person entering the source info. Kinda like the audit trail whodunnit indicator could be telling porky-pies. Go figure
can you elaborate on this? are you saying there was an audit trail built in and then a freeform comment box to indicate who entered source and those two sources didn't jive?
why would you need the comment box if there was already an audit trail? am i missing something here?
Yep, you pretty much got the jist.
So take vitals. I, Richard Cheese take the vitals and type digits in the e-source thing. E-source thing says "Richard Cheese entered these vitals."
And then i have to click into the big ol' comment box at the bottom and type in " Yep, it's ya boi Dick Cheese, i just entered this shizzle, we gucchi"
I RE-HE-HE-HE-HEEEEALY doubt that this is something they required us to do for good ol' redundancy's sake
Digital sources need all kinds of fluffing, validating, re-re-checking, not doing the thing where the source form is leading you to enter stuff that not makes a PD, and on and on it goes. The feeling was- someone dropped the ball (or didn't attempt to pick it up), and the thinly streched staff had to suck up the fruits of that fuckup.
Quote from brad on August 3, 2023, 5:42 pmQuote from Guest on August 3, 2023, 5:09 pmQuote from Guest on July 26, 2023, 8:00 pmYou need to demonstrate that your system can meet the attributes of ALCOA plus. Is it attributable who made the entry and when, who changed the entry (if applicable), can you see the original and updated entry (audit trail), is access managed and not shared (password enforcement), etc. If not, then the FDA can cite you for not having adequate source documentation which comes straight from 21 CFR Part 312.
Pretty much this.
Funny enough, i have a suspicion this was a big one in the whole "trials in a van" thing we recently saw. An esource that had audit trails and all was used, so every section had a little indicator saying which user filled it out. Then at some point came the request to confirm in a freeform comment section who is the person entering the source info. Kinda like the audit trail whodunnit indicator could be telling porky-pies. Go figure
can you elaborate on this? are you saying there was an audit trail built in and then a freeform comment box to indicate who entered source and those two sources didn't jive?
why would you need the comment box if there was already an audit trail? am i missing something here?
Yep, you pretty much got the jist.
So take vitals. I, Richard Cheese take the vitals and type digits in the e-source thing. E-source thing says "Richard Cheese entered these vitals."
And then i have to click into the big ol' comment box at the bottom and type in " Yep, it's ya boi Dick Cheese, i just entered this shizzle, we gucchi"
I RE-HE-HE-HE-HEEEEALY doubt that this is something they required us to do for good ol' redundancy's sake
Digital sources need all kinds of fluffing, validating, re-re-checking, not doing the thing where the source form is leading you to enter stuff that not makes a PD, and on and on it goes. The feeling was- someone dropped the ball (or didn't attempt to pick it up), and the thinly streched staff had to suck up the fruits of that fuckup.
