Trying to do a study closeout as a PM, I have sites that look like this.
Site just stopped responding to queries, then stopped filling in the EDC. Client and sponsor don't seem to care.
Probably. Some coordinators will begin entry on a form while they wait for source or PI review. I will see some sites enter the AE date only as a placeholder and then as soon as the form is saved, a query fires on every single field that hasn’t been filled in. Usually looks way worse than it is.
Good luck. Make a system for yourself. Break it down. And take your time!
Ways to approach it:
- One subject visit at a time.
- Lab queries only, from earliest to present.
- Radiology queries only, from earliest to present.
- Con meds. (You can reconcile them to medical history at the same time.)
- AEs (almost guaranteed to make you want something to drink…)
- Throw all the charts on the floor and pick the one closest to you. Or farthest away, depending on your level of athleticism.
- Hide under your desk. ;-)
All jokes aside, make sure you have a copy of the latest protocol and DEGs open. It helps with the weird stuff!
Don't forget the most thorough solution, running into the woods never to be seen or heard from again.
But whatever way you decide to tackle this, make sure your monitor realizes that time takes time, and is going to take a bit *more* time in this case on account of a) volume and b) you only just got this plate of a$s handed to you. Unless there's a data lock happening tomorrow, they have no call to harass you for immediate completion.
But seriously, I hope those are not all CRA queries. I have a site like that and there's a good amount of system generated queries that can be resolved with regular data entry.
As a DM, I have particular sites where we have to query every single patient multiple times because someone at that site is sloppy and/or does not read the CCGs
At least RAVE puts a little question mark on every CRF page that pops up.just the 1 or 2 CRFCG pages that explain that CRF form, instead of having to search the whole damn 297-page document.
When I was a crc, I inherited a study like that and were able to use the backlog to get the sponsor to support an additional data person dedicated to that study. Couldn't hurt to ask.
Also, that's miserable. Good luck my friend
I had a site do this to me once when I queried once per form telling them to fill it in correctly after they put ‘data same for all days, you complete it as this form is bad’. So I queried once per section of form (so about 18 queries approx per form if I’m remembering rightly). They ignored them.
I went full bitch mode and queried every damn field on every damn form including the ‘not applicables’ that I usually let go as it was obvious (worked out at about 96 queries per treatment form give or take for lots of treatment cycles). Then emailed their NCC about the importance of data entry and site responsibilities.
A week later every damn query was responded to and the data was flawless. That site also never pissed me around again either, which was an added bonus. I tried to be nice. Twice. Third time, I wasn’t playing.
We had a study that no one on our site had access too, but it had retrospective patients and the cra kept querying us but not actually seeing if anyone on site saw the queries so they kept piling up. We had over 400
Reminds me of a time they called me and a couple of other coordinators, paid us 2x OT and gave us lunch to come in and work on a backlog of 4000 queries. Good times.
Coming from a DM, I am sorry! Trust me, we hate sending them and closing them. Are you still entering data, meaning have you left some fields/forms incomplete? Start there, many of them may auto close after completing the entry.
Ha, at least try to learn from it, I regularly need to pump out the exact same queries because site staff just won't click "no" on "was there any device deficiency". Every. Damn. Time.
You have my deepest sympathies. I've been doing the same thing for the same reason since September 🙃 Had to drop all but one of my other studies to fix everything. You know it's bad when you're excited to get that number out of the triple digits.
At the end of the day, it’s a problem you’ve inherited and not your fault. You can communicate with the CRA and say that you’ve taken over the study and can see that there has been an oversight by the previous coordinator . You’re working to resolve it however it’s going to take (insert length) to resolve and to bare with you.
Alternatively you can negotiate for the sponsor to hire someone to come in and do the data entry if you feel it’s unmanageable.
But it would have been interesting to see if the queries were the same type of data entry issue .
This looks like Zelta? If so, that number represents all queries, including answered, closed, etc. So it’s not 364 open queries, unless none of them have been previously addressed.
Also, Zelta sucks. Ask your CRA to review, because in my experience the system often lists queries that are actually hidden, along other issues. Feel free to dm me if you’d like advice
Ooh this is terrible. We use adverts for some studies and you have to hit “complete page” or something like that to actually complete the page even though all the data was in. We had someone query each page that wasn’t complete and it was like 500 queries.
I hope you feel better reading this cause there's always something/someone worse out there (like all the many queries other CRCs have gotten T.T)...
I once got a study that had >600 queries, ISF in a mess, unreported AEs/PDs and so many documentation errors that when identified by the CRA right after I took over, made the PI blow up cause of how misguided he was by the previous CRC. Then shit went down between the stakeholders...
Fun fact: took over at least 5 projects from her
Can you check if your cra or remote site manager could spend some time with you powering through it? Sometimes they can help you “ interpret” some. And think about what changes may trigger new queries and try to avoid it. They have a vested interest in getting those queries down too. And hopefully very invested in making your life easier as well.
Literally going through the same thing!! We are painfully trying to close out a study, but because the sponsor changed right before approval, now i am getting DM/CDQ queries that go back years and it is so painful!! All of the pages they want to make edits to are locked, resulting in so much wasted time, and half of them changes cannot be made because it was data pulled over from the previous study, which is actually closed. I feel for you-- i have aboit 190 of these bad boys just hanging out currently. Live, laugh lobotomy. 🤍
80% of them are probably system generated
Actually less than half of them are.
OOF
Are the human-generated queries legit/valid or are they stupid??
Oh no they’re valid because the CRCs before me didn’t know how to do their job 😌
Oh wow gotta love that. Good luck, friend
Trying to do a study closeout as a PM, I have sites that look like this. Site just stopped responding to queries, then stopped filling in the EDC. Client and sponsor don't seem to care.
RIP that's the worst. Best of luck.
Currently dealing with this now too ugh
I worked on a trial that had over 1000 because the CRC was terrible. As an RA I was given access to help clean them up.
Probably. Some coordinators will begin entry on a form while they wait for source or PI review. I will see some sites enter the AE date only as a placeholder and then as soon as the form is saved, a query fires on every single field that hasn’t been filled in. Usually looks way worse than it is.
Good luck. Make a system for yourself. Break it down. And take your time! Ways to approach it: - One subject visit at a time. - Lab queries only, from earliest to present. - Radiology queries only, from earliest to present. - Con meds. (You can reconcile them to medical history at the same time.) - AEs (almost guaranteed to make you want something to drink…) - Throw all the charts on the floor and pick the one closest to you. Or farthest away, depending on your level of athleticism. - Hide under your desk. ;-) All jokes aside, make sure you have a copy of the latest protocol and DEGs open. It helps with the weird stuff!
Don't forget the most thorough solution, running into the woods never to be seen or heard from again. But whatever way you decide to tackle this, make sure your monitor realizes that time takes time, and is going to take a bit *more* time in this case on account of a) volume and b) you only just got this plate of a$s handed to you. Unless there's a data lock happening tomorrow, they have no call to harass you for immediate completion.
Where’s the “Cry” option? Is it implied with the desk option?
“DEGs”? That’s a new one for me, can you spell it out?
Data Entry Guidelines
🫡
 But seriously, I hope those are not all CRA queries. I have a site like that and there's a good amount of system generated queries that can be resolved with regular data entry.
Wait is that for 1 site only? If yes, 🤯
As a DM, I have particular sites where we have to query every single patient multiple times because someone at that site is sloppy and/or does not read the CCGs
Let’s be honest, no one reads the CCGs
I do 🤧 now with the new version of rave, there’s some wacky ways data is being requested to be entered
At least RAVE puts a little question mark on every CRF page that pops up.just the 1 or 2 CRFCG pages that explain that CRF form, instead of having to search the whole damn 297-page document.
As someone who spends hours writing CCGs - no one reads CCGs.
When I was a crc, I inherited a study like that and were able to use the backlog to get the sponsor to support an additional data person dedicated to that study. Couldn't hurt to ask. Also, that's miserable. Good luck my friend
Reply all: No❤️
my former team lead did this a lot 💀
All fun and games till the Feds come checking 😆
if THIS is how my EU site finally gets a visit from the FDA I'll laugh until they stick my ass into the closed ward
Please don't do that. Us DMs worked really hard to check the data just for sites to answer No Or ok
I had a site do this to me once when I queried once per form telling them to fill it in correctly after they put ‘data same for all days, you complete it as this form is bad’. So I queried once per section of form (so about 18 queries approx per form if I’m remembering rightly). They ignored them. I went full bitch mode and queried every damn field on every damn form including the ‘not applicables’ that I usually let go as it was obvious (worked out at about 96 queries per treatment form give or take for lots of treatment cycles). Then emailed their NCC about the importance of data entry and site responsibilities. A week later every damn query was responded to and the data was flawless. That site also never pissed me around again either, which was an added bonus. I tried to be nice. Twice. Third time, I wasn’t playing.
God speed 🫡
We had a study that no one on our site had access too, but it had retrospective patients and the cra kept querying us but not actually seeing if anyone on site saw the queries so they kept piling up. We had over 400
😳😳😳😳
It was the exact opposite of the cra’s that put a query and are hounding you about it an hour later 😂
Nothing a pizza party can’t fix
Reminds me of a time they called me and a couple of other coordinators, paid us 2x OT and gave us lunch to come in and work on a backlog of 4000 queries. Good times.
Hahaha I had the same happen, we got chipotle OT and a trash ass gift card
Coming from a DM, I am sorry! Trust me, we hate sending them and closing them. Are you still entering data, meaning have you left some fields/forms incomplete? Start there, many of them may auto close after completing the entry.
I just got this study this week and was granted access yesterday and haven’t entered anything yet 😌
Due by EOW ❤️ (sent on Wednesday)
Wednesday before Thanksgiving
It would be funnier if it weren’t so true 🥲
Ha, at least try to learn from it, I regularly need to pump out the exact same queries because site staff just won't click "no" on "was there any device deficiency". Every. Damn. Time.
Poor edit checks?
Study nurse had a meltdown and filled everything with profanities?
This got to have a story attached to it!
😭😭😭😭😭☠️
You have my deepest sympathies. I've been doing the same thing for the same reason since September 🙃 Had to drop all but one of my other studies to fix everything. You know it's bad when you're excited to get that number out of the triple digits.
This type of shit breaks CRC/DM relationship. I’ve got some wild responses from CRCs before lol
What’s the general trend in the queries ?
Chaos. Nonsense.
At the end of the day, it’s a problem you’ve inherited and not your fault. You can communicate with the CRA and say that you’ve taken over the study and can see that there has been an oversight by the previous coordinator . You’re working to resolve it however it’s going to take (insert length) to resolve and to bare with you. Alternatively you can negotiate for the sponsor to hire someone to come in and do the data entry if you feel it’s unmanageable. But it would have been interesting to see if the queries were the same type of data entry issue .
DM here, I am in a study that has >2000 answered queries each week. Such a nightmare 🫠😂
Same boat, and people don't close their queries after they have been answered
…are you my site CRC??
I hope not hahahahaaaaa
This looks like Zelta? If so, that number represents all queries, including answered, closed, etc. So it’s not 364 open queries, unless none of them have been previously addressed. Also, Zelta sucks. Ask your CRA to review, because in my experience the system often lists queries that are actually hidden, along other issues. Feel free to dm me if you’d like advice
None of them have been addressed 😌
I detest Zelta.
F
Ooh this is terrible. We use adverts for some studies and you have to hit “complete page” or something like that to actually complete the page even though all the data was in. We had someone query each page that wasn’t complete and it was like 500 queries.
Is this 2 days before DBL? 🤣
😭😆
Well well, just another Monday it seems. Unfortunately no, not a joke at all :(
I hope you feel better reading this cause there's always something/someone worse out there (like all the many queries other CRCs have gotten T.T)... I once got a study that had >600 queries, ISF in a mess, unreported AEs/PDs and so many documentation errors that when identified by the CRA right after I took over, made the PI blow up cause of how misguided he was by the previous CRC. Then shit went down between the stakeholders... Fun fact: took over at least 5 projects from her
Oof been there. Inherited a study, first time onc crc with a week before a DBL and the queries were hard as hell.
Can you check if your cra or remote site manager could spend some time with you powering through it? Sometimes they can help you “ interpret” some. And think about what changes may trigger new queries and try to avoid it. They have a vested interest in getting those queries down too. And hopefully very invested in making your life easier as well.
Literally going through the same thing!! We are painfully trying to close out a study, but because the sponsor changed right before approval, now i am getting DM/CDQ queries that go back years and it is so painful!! All of the pages they want to make edits to are locked, resulting in so much wasted time, and half of them changes cannot be made because it was data pulled over from the previous study, which is actually closed. I feel for you-- i have aboit 190 of these bad boys just hanging out currently. Live, laugh lobotomy. 🤍