Welcome to Clinical Trial Confidential.
We believe the clinical trial industry lacks a platform for open, transparent conversation. This lack of transparency inhibits progress. In this industry, that means patients are the ones that suffer.
Here you can choose to register an account, post anonymously or both. It is our hope that the ability to post anonymously will help foster useful conversation by allowing users to express their opinions without fear of retaliation, fear of appearing ignorant and otherwise allowing users to express opinions that may be contrary to their employer or that their position may not permit.
We believe great ideas should stand on their own merit and not the credentials of their author.
We hope these values will foster an environment of collaboration.
Quote from brad on May 4, 2022, 1:37 pmThis isn't exactly a horror story but we had a recent SIV where we learned we have to send patients for a shingles vaccine before they can screen in.
This isn't accounted for in the budget and we let the CRA know that. We think it's unreasonable to ask uninsured patients to pay $150+ just to be considered for the trial.
Her response was "Oh, what, is $150 a lot of money to people around here. They can pay for it themselves" which I thought was pretty fucking insensitive. It makes me wonder why people are in this business in the first place.
Anyone else have terrible CRA experiences to share?
This isn't exactly a horror story but we had a recent SIV where we learned we have to send patients for a shingles vaccine before they can screen in.
This isn't accounted for in the budget and we let the CRA know that. We think it's unreasonable to ask uninsured patients to pay $150+ just to be considered for the trial.
Her response was "Oh, what, is $150 a lot of money to people around here. They can pay for it themselves" which I thought was pretty fucking insensitive. It makes me wonder why people are in this business in the first place.
Anyone else have terrible CRA experiences to share?
Quote from OutdatedECG on May 4, 2022, 3:48 pmWe have a current IQVIA CRA we are dealing with who we actually have asked to be taken off our study.
She's never available by phone and her OOO auto email is constantly on. We can NEVER reach her when we need her.
We had to randomize a patient, but the IRT system was telling us we didn't have drug onsite to do that. We did.
We called her (she picked up because she new we were randomizing) and told her we think the issue is that we have a shipment in-transit and it won't let us randomize until we confirm receipt of that shipment.
She firmly disagreed and said it had to be that we did not confirm receipt of a past shipment which was the problem. So she was going to talk to her clinical lead to ask what to do.
We took it upon ourselves to call the IRT company and while we are on the phone the shipment of new IP showed up. We confirmed the shipment and guess what... we were able to randomize!
This happened this morning at 9:30am. its 11:45, she still hasn't called back.
They told us they couldn't take her off our site for some reason, so we are stuck with her apparently.
She also failed to pass on vital information for certain things that needed to be done for randomization of our first subject in this study, which resulted in a longer visit for the patient.
We were told specifically by the sponsor that the communications of the CRA are inappropriate and they would be talking with IQVIA about it. But, they didn't give us a new CRA and we haven't even had recognition from her of her mistakes.
Never experienced anything like this before.
We have a current IQVIA CRA we are dealing with who we actually have asked to be taken off our study.
She's never available by phone and her OOO auto email is constantly on. We can NEVER reach her when we need her.
We had to randomize a patient, but the IRT system was telling us we didn't have drug onsite to do that. We did.
We called her (she picked up because she new we were randomizing) and told her we think the issue is that we have a shipment in-transit and it won't let us randomize until we confirm receipt of that shipment.
She firmly disagreed and said it had to be that we did not confirm receipt of a past shipment which was the problem. So she was going to talk to her clinical lead to ask what to do.
We took it upon ourselves to call the IRT company and while we are on the phone the shipment of new IP showed up. We confirmed the shipment and guess what... we were able to randomize!
This happened this morning at 9:30am. its 11:45, she still hasn't called back.
They told us they couldn't take her off our site for some reason, so we are stuck with her apparently.
She also failed to pass on vital information for certain things that needed to be done for randomization of our first subject in this study, which resulted in a longer visit for the patient.
We were told specifically by the sponsor that the communications of the CRA are inappropriate and they would be talking with IQVIA about it. But, they didn't give us a new CRA and we haven't even had recognition from her of her mistakes.
Never experienced anything like this before.
Quote from brad on May 4, 2022, 3:53 pmQuote from OutdatedECG on May 4, 2022, 3:48 pmWe have a current IQVIA CRA we are dealing with who we actually have asked to be taken off our study.
She's never available by phone and her OOO auto email is constantly on. We can NEVER reach her when we need her.
We had to randomize a patient, but the IRT system was telling us we didn't have drug onsite to do that. We did.
We called her (she picked up because she new we were randomizing) and told her we think the issue is that we have a shipment in-transit and it won't let us randomize until we confirm receipt of that shipment.
She firmly disagreed and said it had to be that we did not confirm receipt of a past shipment which was the problem. So she was going to talk to her clinical lead to ask what to do.
We took it upon ourselves to call the IRT company and while we are on the phone the shipment of new IP showed up. We confirmed the shipment and guess what... we were able to randomize!
This happened this morning at 9:30am. its 11:45, she still hasn't called back.
They told us they couldn't take her off our site for some reason, so we are stuck with her apparently.
She also failed to pass on vital information for certain things that needed to be done for randomization of our first subject in this study, which resulted in a longer visit for the patient.
We were told specifically by the sponsor that the communications of the CRA are inappropriate and they would be talking with IQVIA about it. But, they didn't give us a new CRA and we haven't even had recognition from her of her mistakes.
Never experienced anything like this before.
That's a whole new level of insanity. I would bitch and moan to the sponsor non-stop until they replaced her. Sorry you have to deal with that. Crazy stuff.
Quote from OutdatedECG on May 4, 2022, 3:48 pmWe have a current IQVIA CRA we are dealing with who we actually have asked to be taken off our study.
She's never available by phone and her OOO auto email is constantly on. We can NEVER reach her when we need her.
We had to randomize a patient, but the IRT system was telling us we didn't have drug onsite to do that. We did.
We called her (she picked up because she new we were randomizing) and told her we think the issue is that we have a shipment in-transit and it won't let us randomize until we confirm receipt of that shipment.
She firmly disagreed and said it had to be that we did not confirm receipt of a past shipment which was the problem. So she was going to talk to her clinical lead to ask what to do.
We took it upon ourselves to call the IRT company and while we are on the phone the shipment of new IP showed up. We confirmed the shipment and guess what... we were able to randomize!
This happened this morning at 9:30am. its 11:45, she still hasn't called back.
They told us they couldn't take her off our site for some reason, so we are stuck with her apparently.
She also failed to pass on vital information for certain things that needed to be done for randomization of our first subject in this study, which resulted in a longer visit for the patient.
We were told specifically by the sponsor that the communications of the CRA are inappropriate and they would be talking with IQVIA about it. But, they didn't give us a new CRA and we haven't even had recognition from her of her mistakes.
Never experienced anything like this before.
That's a whole new level of insanity. I would bitch and moan to the sponsor non-stop until they replaced her. Sorry you have to deal with that. Crazy stuff.
Quote from Jeanette on May 6, 2022, 1:18 amA certain CRO hires PharmD's as new CRAs and I wish it would stop. It is so painful for everyone.
A certain CRO hires PharmD's as new CRAs and I wish it would stop. It is so painful for everyone.
Quote from brad on May 6, 2022, 1:23 amQuote from Site-Line on May 6, 2022, 1:18 amA certain CRO hires PharmD's as new CRAs and I wish it would stop. It is so painful for everyone.
At least they can maybe pronounce half the words in the slides they're going to read to us word for word.
Quote from Site-Line on May 6, 2022, 1:18 amA certain CRO hires PharmD's as new CRAs and I wish it would stop. It is so painful for everyone.
At least they can maybe pronounce half the words in the slides they're going to read to us word for word.
Quote from Jeanette on May 6, 2022, 1:47 amQuote from brad on May 6, 2022, 1:23 amQuote from Site-Line on May 6, 2022, 1:18 amA certain CRO hires PharmD's as new CRAs and I wish it would stop. It is so painful for everyone.
At least they can maybe pronounce half the words in the slides they're going to read to us word for word.
Oh my gosh, they CAN! I am absolutely going to determine the competency of our CRA at SIV based on their slide presentation now. >80% effortless pronunciation = CRA fail
Quote from brad on May 6, 2022, 1:23 amQuote from Site-Line on May 6, 2022, 1:18 amA certain CRO hires PharmD's as new CRAs and I wish it would stop. It is so painful for everyone.
At least they can maybe pronounce half the words in the slides they're going to read to us word for word.
Oh my gosh, they CAN! I am absolutely going to determine the competency of our CRA at SIV based on their slide presentation now. >80% effortless pronunciation = CRA fail
Quote from Guest on May 10, 2022, 4:51 pmI took over a new study after I started a new position within my university which had been ongoing for over 7 years (4 ISFs)… after I informed the CRA that flu shots were required to monitor on-site and she refused I ended up getting a new CRA assigned, she was a disaster. She showed up to monitor for a two day visit and stayed less than 45 min the first day and maybe 30 min the second day. After that she proceeded to send me a 3 page list of items that she wanted copies of. I politely let her know they were available onsite during monitoring and she had access to them for the duration of that visit for which she didn’t stay onsite for either day. She got nasty and insisted I send those items. I told her we could set up another visit and she ccd her manager on the email. In reached out to her boss and requested a new CRA due to what happened and her complete lack of professionalism. They left her on the study for many more months and than the pandemic happened so I didn’t ever have to see her again. Thank goodness. I was so angry, Im willing to work with people and get copies but not 3 pages worth!
I also find total irony in the fact that the original CRA wouldn’t get the flu shot and now people don’t balk at a covid vaccine requirement.
I took over a new study after I started a new position within my university which had been ongoing for over 7 years (4 ISFs)… after I informed the CRA that flu shots were required to monitor on-site and she refused I ended up getting a new CRA assigned, she was a disaster. She showed up to monitor for a two day visit and stayed less than 45 min the first day and maybe 30 min the second day. After that she proceeded to send me a 3 page list of items that she wanted copies of. I politely let her know they were available onsite during monitoring and she had access to them for the duration of that visit for which she didn’t stay onsite for either day. She got nasty and insisted I send those items. I told her we could set up another visit and she ccd her manager on the email. In reached out to her boss and requested a new CRA due to what happened and her complete lack of professionalism. They left her on the study for many more months and than the pandemic happened so I didn’t ever have to see her again. Thank goodness. I was so angry, Im willing to work with people and get copies but not 3 pages worth!
I also find total irony in the fact that the original CRA wouldn’t get the flu shot and now people don’t balk at a covid vaccine requirement.
Quote from CJO on May 12, 2022, 12:36 amQuote from Jeanette on May 6, 2022, 1:18 amA certain CRO hires PharmD's as new CRAs and I wish it would stop. It is so painful for everyone.
🤣Shall I take this personal, Jeanette....just kidding. Being a PharmD by education (that's different from experience) myself- titles by graduation do not tell if someone is good at their job. And nope, I am not planning on becoming a CRA.
Thanks for all your freely shared experience. Truly appreciated.
Quote from Jeanette on May 6, 2022, 1:18 amA certain CRO hires PharmD's as new CRAs and I wish it would stop. It is so painful for everyone.
🤣Shall I take this personal, Jeanette....just kidding. Being a PharmD by education (that's different from experience) myself- titles by graduation do not tell if someone is good at their job. And nope, I am not planning on becoming a CRA.
Thanks for all your freely shared experience. Truly appreciated.
Quote from CJO on May 12, 2022, 12:43 amMy horror story - one CRA had the tendency to only be satisfied when she could report major deviations etc to the sponsor. And if there was no such thing, she made something up. And for sure- reports have been shared many weeks later and no mentioning in our concluding PI meeting before....
Long story short- we went from Capa to Capa to being reported as repeatedly non-compliant (what is a big concern for IRB and FDA!) and it cost us not only the study but also the partnership with the sponsor.
And even the sponsor might have figured later who stirred the pot - no chance to recover from that because it would include some balls.....
We have a long way to go TOGETHER. Let's do it.
My horror story - one CRA had the tendency to only be satisfied when she could report major deviations etc to the sponsor. And if there was no such thing, she made something up. And for sure- reports have been shared many weeks later and no mentioning in our concluding PI meeting before....
Long story short- we went from Capa to Capa to being reported as repeatedly non-compliant (what is a big concern for IRB and FDA!) and it cost us not only the study but also the partnership with the sponsor.
And even the sponsor might have figured later who stirred the pot - no chance to recover from that because it would include some balls.....
We have a long way to go TOGETHER. Let's do it.
Quote from Jeanette on May 12, 2022, 1:01 amShall I take this personal, Jeanette....just kidding. Being a PharmD by education (that's different from experience) myself- titles by graduation do not tell if someone is good at their job. And nope, I am not planning on becoming a CRA.
Thanks for all your freely shared experience. Truly appreciated.Nooo. Please don't. It's only their hiring requirement that kills me because that degree shouldn't be a necessity, especially as a site's point of contact. We have these baby CRA PharmDs, bless them, who know everything about pharmacology, and nothing about "research", and I want to cry every day.
Shall I take this personal, Jeanette....just kidding. Being a PharmD by education (that's different from experience) myself- titles by graduation do not tell if someone is good at their job. And nope, I am not planning on becoming a CRA.
Thanks for all your freely shared experience. Truly appreciated.
Nooo. Please don't. It's only their hiring requirement that kills me because that degree shouldn't be a necessity, especially as a site's point of contact. We have these baby CRA PharmDs, bless them, who know everything about pharmacology, and nothing about "research", and I want to cry every day.
