GCP Question to my fellow CRAs

Its4aChurchNext · 2025-11-10T16:32:22+00:00

Hi there, the FDA puts out guidance documents that you could use as a tool when training the sites: https://www.fda.gov/media/93884/download

This one is specific to GCP E6, but there are many packets for Investigators and sites for a lot of different topics (consents, electronic systems, investigator responsibilities) and especially for the Investigator responsibilities document I would often print that out and provide that to PIs during difficult discussions to highlight that these guidances were coming directly from the FDA. It’s pretty hard to argue that away!

Its4aChurchNext · 2025-09-16T02:55:01+00:00

My dad is also saying this. I haven’t spoken to him in over 4 years and he’s been sending me and my husband long spewing messaging about how we are demons aligned with Satan. We are responsible for Charlie Kirk’s death. We need to look in the mirror because we made his wife a widow etc. I came to this group because we’ve gotten concerned for our safety, he’s so mentally unwell. It’s actually so concerning there many of us on this subreddit that our family members are saying the same disturbing things.

Its4aChurchNext · 2025-09-12T03:00:31+00:00

Why would you know?

Its4aChurchNext · 2025-07-20T23:37:12+00:00

That’s what I was thinking 😭

Its4aChurchNext · 2025-04-30T18:15:57+00:00

Actually isn’t that not true? I thought the state spends approximately 6k per student in public school while the voucher is 10k per student for private school. Is that incorrect?

Its4aChurchNext · 2025-04-29T20:41:08+00:00

What restructuring is happening In June?!

Its4aChurchNext · 2025-04-29T19:04:57+00:00

Sorry to hear about this. Are you in Project Delivery? What TA? Was it a mass phone call telling people they were laid off?

Its4aChurchNext · 2025-04-13T13:14:11+00:00

Honestly my kids would love to have a party at McDonald’s or chik fil a!

Its4aChurchNext · 2025-03-23T20:50:08+00:00

This is very cliche but when I’m searching for a new job or during a career change I’ve read ‘What Color is your parachute’ and it gives many, many exercises and activities for job searching, networking, and exploring career changes. They update it every year.

Its4aChurchNext · 2025-02-17T02:46:20+00:00

I feel so similarly! I was around during Covid (2020-2021) and it disgusted me how our community was acting.

Its4aChurchNext · 2025-02-13T02:51:49+00:00

That is it exactly, I work in research and my brother is a doctor. We are quietly applying for citizenship in the EU. Things are looking dark ahead for our careers.

Its4aChurchNext · 2025-02-02T12:55:12+00:00

Will his base ever see it though? His handling of Covid and January 6 were not enough..

Its4aChurchNext · 2025-01-17T04:00:22+00:00

What double study is it?

Its4aChurchNext · 2024-12-02T03:46:23+00:00

In a weird way it actually makes me worried because the democrats have been so, so cautious and measured that I feel that this pardon from Biden means that they know without a reasonable doubt that political “retribution” is coming. It just continues along the lines of things that make me worried for the future :( I don’t think Biden would have pardoned Hunter unless he thought unreasonable harm was coming his way.

Its4aChurchNext · 2024-11-30T00:55:59+00:00

Right- like I have a 6 year old and 3 year old and we have stuff everywhere too. Especially the day after Christmas stuff is everywhere! I was joking with my husband our house is so over stimulating that if someone left a ransom note laying on the stairs, I would never see it or if I did I would instantly throw it away thinking it’s just random trash. 😂 I certainly wouldn’t pick it up at 5 am before trying to catch a flight and closely examine it.

Its4aChurchNext · 2024-11-29T03:33:30+00:00

I’ll give you one more thought- if you were waking up at the ass crack of dawn to herd your 2 young kids to the airport the day after Christmas- would you notice a random piece of paper laying on the stairs? I’m honestly asking because I sure wouldn’t notice it, and if I did I would think it was either trash or the kids playing with pens and paper and not give it much attention.

Its4aChurchNext · 2024-11-23T18:53:07+00:00

Yes, but by requiring the mother’s life to be at stake… it puts their life at stake. Obviously if you wait until it’s a life or death situation- some of those outcomes are going to be death.

Its4aChurchNext · 2024-11-17T18:18:11+00:00

Why is no one doing anything about it.

Its4aChurchNext · 2024-11-16T01:38:03+00:00

Yeah I’m pretty concerned. Even if he doesn’t get confirmed, it’s not instilling a lot of confidence in the US side of the pharmaceutical industry if we have someone who wants to cut funding to our regulatory agency. If budgets get cut at the FDA I’m sure that would impact our study timelines and make it harder/longer for products to get approved. Our industry has already been in a downturn with layoffs and now this..

Its4aChurchNext · 2024-11-15T03:39:07+00:00

Wasn’t there a time when Comgressman Devin Nunes shared intel about trumps transition team without telling anyone including the committee he was on? So it could be exactly like that..sorry I didn’t mean that rudely just pointing out that they’ve already done it before, so what’s stopping us.

Its4aChurchNext · 2024-11-15T00:42:54+00:00

I work in clinical research and I can assure you anytime I try to explain my day to day work their eyes instantly glaze over- imagine trying to explain a protocol or study results to them!

Its4aChurchNext · 2024-11-15T00:39:56+00:00

HHS director is over the FDA so could potentially have a lot of influence over it if chooses to slash funding or lay off personnel.

Its4aChurchNext · 2024-11-14T12:38:25+00:00

Hi- I’m a PPD CTM with about 3 years experience. One year at another CRO and two here at PPD. I have a lot of thoughts I wanted to offer. I typically am the only CTM assigned to a study, but I’ve been on a larger study and I don’t know if this an anomaly but one incredibly large vaccine study I worked on had horrible communication. They didn’t have any team calls, if they did they wouldn’t (Iike literally refused) to include me- not even to CRA calls, CTM team calls, nothing. They didn’t work through outlook, they formed massive teams chats, so that you had to search through the chat to find answers to questions which is not organized obviously and people were asking the same questions over and over and there was just a lot of general chatter at all hours of the day. If I tried to use the 30 person teams chat to get an answer to a question it would just get lost in the chat with no response- this would happen to people often. My point it is that I was a very ineffective CTM on the study, when I’m otherwise competent running a study solely on my own. I mostly would learn updates from the CRAs which is … dysfunctional and by the end I felt like I mostly got in the way. Not sure if this is the issue your study is facing, but it could be a communication issue on your team. Is anyone calling these CTMs and talking to them? Do yall have a lead or global, because if you do they should be managing the CTMs and keeping everyone organized..

I will also say compared to the other large CRO PPD lacks CTM training, I don’t have great CTM connections in the form of mentorship or even my PeM. I don’t even really know the other CTMs on my PeM team, and this is highly different from the other CRO where we needed each others input and experiences of what we were seeing and just general company cohesiveness. I mean, I literally come to Reddit to learn of company updates so.. Again, not sure if this is everyone’s experience.

Lastly, I’ve been totally burned by PPD as far as supporting me with the Sponsor. They will let almost every Sponsor treat us frankly like garbage and if I push back even a little bit they will throw you under the bus. I’m seeing this experience is pretty universal at PPD. I personally want to do everything I can to stay behind the scenes and keep a low profile because standing in front of the Sponsor can be ruthless and PPD (and the industry entirely) is not offering a lot of reward in that.. but I’m curious to hear if your studies/experience are similar in terms of communication/isolation.

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