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Quote from Jeanette on May 5, 2022, 11:50 pmI'll start:
Did you know the manual FDA inspectors follow to conduct site inspections is posted on the FDA website? Here it is:
(I am still learning to navigate Word Press, so I will only upload one document for now.)
I'll start:
Did you know the manual FDA inspectors follow to conduct site inspections is posted on the FDA website? Here it is:
(I am still learning to navigate Word Press, so I will only upload one document for now.)
Uploaded files:
Quote from Jeanette on May 6, 2022, 12:12 amBelow are free staff training resources:
Good Clinical Practice (GCP) through National Drug Abuse Treatment Clinical Trials Network, funded by National Institute on Drug Abuse (NIDA):
Training for the handling/offering for transportation of dangerous goods per 49CFR 172.700/IATA
Below are free staff training resources:
Good Clinical Practice (GCP) through National Drug Abuse Treatment Clinical Trials Network, funded by National Institute on Drug Abuse (NIDA):
Training for the handling/offering for transportation of dangerous goods per 49CFR 172.700/IATA
Quote from brad on May 6, 2022, 1:17 amQuote from Site-Line on May 6, 2022, 12:12 amBelow are free staff training resources:
Good Clinical Practice (GCP) through National Drug Abuse Treatment Clinical Trials Network, funded by National Institute on Drug Abuse (NIDA):
Training for the handling/offering for transportation of dangerous goods per 49CFR 172.700/IATA
We use these. Thanks for posting them. I take for granted that people might not know about them.
Quote from Site-Line on May 6, 2022, 12:12 amBelow are free staff training resources:
Good Clinical Practice (GCP) through National Drug Abuse Treatment Clinical Trials Network, funded by National Institute on Drug Abuse (NIDA):
Training for the handling/offering for transportation of dangerous goods per 49CFR 172.700/IATA
We use these. Thanks for posting them. I take for granted that people might not know about them.
Quote from brad on May 6, 2022, 1:22 amI always thought this was really cool
https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/replies-inquiries-fda-good-clinical-practice
It's FDA responses to emails about GCP. Fun rabbit hole.
I always thought this was really cool
It's FDA responses to emails about GCP. Fun rabbit hole.
Quote from Jeanette on May 6, 2022, 1:25 amI wish I could incorporate my One-Note files to this forum - or at least change the font. I have a lot more to post, but need to learn WordPress more before I do, so my posts won't appear so sloppy.
Thank you for creating this website Brad. I talk about your podcast to everyone I know in this industry. Don't ever leave!
I wish I could incorporate my One-Note files to this forum - or at least change the font. I have a lot more to post, but need to learn WordPress more before I do, so my posts won't appear so sloppy.
Thank you for creating this website Brad. I talk about your podcast to everyone I know in this industry. Don't ever leave!
Quote from brad on May 6, 2022, 1:27 amQuote from Site-Line on May 6, 2022, 1:25 amI wish I could incorporate my One-Note files to this forum - or at least change the font. I have a lot more to post, but need to learn WordPress more before I do, so my posts won't appear so sloppy.
Thank you for creating this website Brad. I talk about your podcast to everyone I know in this industry. Don't ever leave!
I'm still learning it myself so feel free to reach out and I'll see what I might be able to fix to make it easier.
I'll keep doing this even if no one pays attention. Don't worry about that.
Quote from Site-Line on May 6, 2022, 1:25 amI wish I could incorporate my One-Note files to this forum - or at least change the font. I have a lot more to post, but need to learn WordPress more before I do, so my posts won't appear so sloppy.
Thank you for creating this website Brad. I talk about your podcast to everyone I know in this industry. Don't ever leave!
I'm still learning it myself so feel free to reach out and I'll see what I might be able to fix to make it easier.
I'll keep doing this even if no one pays attention. Don't worry about that.
Quote from OutdatedECG on May 6, 2022, 12:16 pmQuote from Site-Line on May 5, 2022, 11:50 pmI'll start:
Did you know the manual FDA inspectors follow to conduct site inspections is posted on the FDA website? Here it is:
(I am still learning to navigate Word Press, so I will only upload one document for now.)
Thanks for posting this! I never knew this existed so it's super helpful. So... I noticed this will reading it.
"Domestic inspections are usually not announced prior to arriving at the site. Any instructions for announcing the inspection will be in the inspection assignment. Should ORA investigators have questions on whether or not to announce the inspection, the center POC should be contacted."
I was always told by my investigator the that the FDA inspections would usually be announced (like for studies for which we are high enrollers) unless the FDA felt the site was participating in some sort of fraud... but by this statement it seems that's not true?
Anybody have experience with audits? Should I start panicking now?
Quote from Site-Line on May 5, 2022, 11:50 pmI'll start:
Did you know the manual FDA inspectors follow to conduct site inspections is posted on the FDA website? Here it is:
(I am still learning to navigate Word Press, so I will only upload one document for now.)
Thanks for posting this! I never knew this existed so it's super helpful. So... I noticed this will reading it.
"Domestic inspections are usually not announced prior to arriving at the site. Any instructions for announcing the inspection will be in the inspection assignment. Should ORA investigators have questions on whether or not to announce the inspection, the center POC should be contacted."
I was always told by my investigator the that the FDA inspections would usually be announced (like for studies for which we are high enrollers) unless the FDA felt the site was participating in some sort of fraud... but by this statement it seems that's not true?
Anybody have experience with audits? Should I start panicking now?
Quote from Jeanette on May 6, 2022, 3:34 pmQuote from OutdatedECG on May 6, 2022, 12:16 pmQuote from Site-Line on May 5, 2022, 11:50 pmI'll start:
Did you know the manual FDA inspectors follow to conduct site inspections is posted on the FDA website? Here it is:
(I am still learning to navigate Word Press, so I will only upload one document for now.)
Thanks for posting this! I never knew this existed so it's super helpful. So... I noticed this will reading it.
"Domestic inspections are usually not announced prior to arriving at the site. Any instructions for announcing the inspection will be in the inspection assignment. Should ORA investigators have questions on whether or not to announce the inspection, the center POC should be contacted."
I was always told by my investigator the that the FDA inspections would usually be announced (like for studies for which we are high enrollers) unless the FDA felt the site was participating in some sort of fraud... but by this statement it seems that's not true?
Anybody have experience with audits? Should I start panicking now?
Nice find. We have been inspected (Routine, not for cause) and I did receive a phone call beforehand. Granted, the phone call was on a Friday notifying me the inspection was occurring on Tuesday (with the preceding Monday being a holiday). It is comical that the manual states "Should ORA investigators have questions have questions on whether or not to announce the inspection, the center POC should be contacted." That is seriously fantastic.
I will also add that when I received the phone call, the FDA inspector told me he will need to have access to the reserve samples. The study being inspected was before my time, but I immediately knew we had no reserve samples. I tried not the panic I was feeling be known as he continued on with the call. After I hung up the phone, I immediately contacted the sponsor, reviewed the protocol/lab manual and was reassured that no samples were to be stored on site. Of course though, I spent the entire weekend stressing about these reserve samples. When he arrived, I explained that all samples were shipped to the lab - none were stored on-site. He was convinced they should be kept on site, even though this was not in the protocol or lab manual. I am grateful I worked up the courage to stand my ground because we got through it and he apologized for the misunderstanding. The big takeaway from it, if you feel there is a misunderstanding, it's okay to ask an FDA inspector to show you their rationale.
Quote from OutdatedECG on May 6, 2022, 12:16 pmQuote from Site-Line on May 5, 2022, 11:50 pmI'll start:
Did you know the manual FDA inspectors follow to conduct site inspections is posted on the FDA website? Here it is:
(I am still learning to navigate Word Press, so I will only upload one document for now.)
Thanks for posting this! I never knew this existed so it's super helpful. So... I noticed this will reading it.
"Domestic inspections are usually not announced prior to arriving at the site. Any instructions for announcing the inspection will be in the inspection assignment. Should ORA investigators have questions on whether or not to announce the inspection, the center POC should be contacted."
I was always told by my investigator the that the FDA inspections would usually be announced (like for studies for which we are high enrollers) unless the FDA felt the site was participating in some sort of fraud... but by this statement it seems that's not true?
Anybody have experience with audits? Should I start panicking now?
Nice find. We have been inspected (Routine, not for cause) and I did receive a phone call beforehand. Granted, the phone call was on a Friday notifying me the inspection was occurring on Tuesday (with the preceding Monday being a holiday). It is comical that the manual states "Should ORA investigators have questions have questions on whether or not to announce the inspection, the center POC should be contacted." That is seriously fantastic.
I will also add that when I received the phone call, the FDA inspector told me he will need to have access to the reserve samples. The study being inspected was before my time, but I immediately knew we had no reserve samples. I tried not the panic I was feeling be known as he continued on with the call. After I hung up the phone, I immediately contacted the sponsor, reviewed the protocol/lab manual and was reassured that no samples were to be stored on site. Of course though, I spent the entire weekend stressing about these reserve samples. When he arrived, I explained that all samples were shipped to the lab - none were stored on-site. He was convinced they should be kept on site, even though this was not in the protocol or lab manual. I am grateful I worked up the courage to stand my ground because we got through it and he apologized for the misunderstanding. The big takeaway from it, if you feel there is a misunderstanding, it's okay to ask an FDA inspector to show you their rationale.
Quote from brad on May 7, 2022, 3:58 pmDon't forget.
FDA Clinical Trial Guidance Documents:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
And everyone's favorite bed time reading, Codes of Federal Regulations:
https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials
I'm no compliance expert but I find I refer to these often.
Don't forget.
FDA Clinical Trial Guidance Documents:
And everyone's favorite bed time reading, Codes of Federal Regulations:
I'm no compliance expert but I find I refer to these often.
Quote from Jeanette on May 7, 2022, 5:33 pmQuote from brad on May 7, 2022, 3:58 pmDon't forget.
FDA Clinical Trial Guidance Documents:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
And everyone's favorite bed time reading, Codes of Federal Regulations:
https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials
I'm no compliance expert but I find I refer to these often.
While best practice is to of course follow guidance, I think it's important for people in the industry to be aware of the meaning behind "guidance" vs "regulations".
The more you understand, the better off you are.
Simply put:
- Regulations = Binding. Rules. Carries the force of the law.
- Guidelines = FDA's best advice. Interpretation of the Regulations. Not binding.
My best advice, however? When it comes to compliance, don't ever trust a stranger on the internet. Here is the FDA's explanation:
Quote from brad on May 7, 2022, 3:58 pmDon't forget.
FDA Clinical Trial Guidance Documents:
And everyone's favorite bed time reading, Codes of Federal Regulations:
I'm no compliance expert but I find I refer to these often.
While best practice is to of course follow guidance, I think it's important for people in the industry to be aware of the meaning behind "guidance" vs "regulations".
The more you understand, the better off you are.
Simply put:
My best advice, however? When it comes to compliance, don't ever trust a stranger on the internet. Here is the FDA's explanation:
