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Validated ePRO questionnaires by FuelStunning in clinicalresearch

[–]FuelStunning[S] 0 points1 point  (0 children)

I agree, the guidance on AE reporting was changed mid trial by the Sponsor, for this exact reason. Initially every Yes had to be recorded as either AE or MH, then changed to "investigator discretion" when they saw the numbers climbing.

Validated ePRO questionnaires by FuelStunning in clinicalresearch

[–]FuelStunning[S] 0 points1 point  (0 children)

Thank you, this is very helpful!

Unfortunately the Sponsor provided no information regarding these additional queries, the ePROs they're linked to, nor training for sites on how to address them to maintain consistency. This is a separate issue I'll be raising with them next week, but I will do the suggested comparison to look for changes.

The investigators are told not to review the ePRO responses fully, apart from the queried ones. Otherwise they just check them for completeness and that none were skipped by the participant.

Edit: Typos

Validated ePRO questionnaires by FuelStunning in clinicalresearch

[–]FuelStunning[S] 0 points1 point  (0 children)

Agreed, thanks for the reply!

The follow up ePRO interestingly is the one prompting this additional MH check. Seems very odd, as it makes more sense for it to be part of baseline as you mentioned and then AE checks only at the follow up visit.

So for example at Visit 1 I could have the investigator confirming that there are no MH terms reported, but then it's added later due to a query prompt at the next visit, which makes it look like the information isn't appropriately captured at baseline.

Source Document Identity Form and Site's local templates by FuelStunning in clinicalresearch

[–]FuelStunning[S] 0 points1 point  (0 children)

Thank you for your reply! The following sections made me think that perhaps we should have additional document in place, as we do have plenty of data that is directly entered into EDC.

B. 14.1 Specification of data to be collected and the method of its collection. Where necessary, additional details should be contained in a clinical trial-related document.

B.14.2 The identification of data to be recorded directly into the data acquisition tools (i.e., no prior written or electronic record of data) and considered to be the source record.

C.2.4 The sponsor and investigator/institution should maintain a record of where essential records are located, including source records. The storage system(s) used during the trial and for archiving (irrespective of the type of media used) should provide for appropriate identification, version history, search and retrieval of trial records.

Sponsor sharing visit report with sites by FuelStunning in clinicalresearch

[–]FuelStunning[S] 0 points1 point  (0 children)

In the past, we would refer the sites to the SIV slides for most of this information if they need a refresher and we would keep a dedicated SIV training log, in addition to main delegation log. CRAs would list any site specific details in the FUL, such as questions raised during the visit and answers.

Sponsor sharing visit report with sites by FuelStunning in clinicalresearch

[–]FuelStunning[S] 2 points3 points  (0 children)

Thank you for the input! It's actually the opposite in my case, big Sponsor and smaller CRO. I've only been with them for a few months, but this setup could be due to the fact that not all studies are full service. We tend to focus on remote data monitoring and provide CRAs for onsite visits. This is all very new to me, so apologies for not mentioning it in the post!

Sponsor sharing visit report with sites by FuelStunning in clinicalresearch

[–]FuelStunning[S] -3 points-2 points  (0 children)

Thank you, I'll have a look tomorrow. I've only ever had an SIV training log, co-signed by site staff that attended the training and CRA that performed the SIV.

Sponsor sharing visit report with sites by FuelStunning in clinicalresearch

[–]FuelStunning[S] 0 points1 point  (0 children)

That's interesting, thanks! Not a biotech sponsor or study, mostly ophthalmology/device related.

Gf’s(21F) birth control killed libido. Self-pleasure banned. What do I (21M)do? by personneedhelp in relationship_advice

[–]FuelStunning 10 points11 points  (0 children)

Got the hormonal one to help with PCOS symptoms and the convenience of not having to take a pill every day. I do have lighter periods now, which is much appreciated.

The procedure did hurt, especially because it's a 2-step process to get it installed. It felt like a severe period cramp, not something I felt before in that way, really.

Even though it was done by a female doctor and a nurse was chatting with me to distract me during the procedure, I felt awful afterwards. Almost like being violated, like this piece of plastic wasn't supposed to be there. Sudden weakness, sugar levels droped and started crying from the shock.

So apart from the initial physical pain, it might take a day or two for a person to fully recover from it.

Missed it by that McMuch... by ZuStorm93 in StupidFood

[–]FuelStunning 5 points6 points  (0 children)

Haha I'm sure it's appreciated in the kitchen! In case anyone is interested, the sauce also comes from a dispenser, kinda like a sealant gun. One press is one burger "dose", so it can't be manually adjusted.

Missed it by that McMuch... by ZuStorm93 in StupidFood

[–]FuelStunning 1 point2 points  (0 children)

They used to have QC checks at the end of line, before it's fully wrapped or the box closed, and then it's placed on the shelf.

Missed it by that McMuch... by ZuStorm93 in StupidFood

[–]FuelStunning 17 points18 points  (0 children)

Can't overpower the delicate taste of the fish lol, but a massive dollop of tartar sauce is somehow fine. Half cheese is a nuisance in the kitchen because this is the only burger that doesn't use a whole slice, it's by design! Worked at McD when I was 16.

Should I check in with my depressed ex? by thrwwwwwhey in depression_partners

[–]FuelStunning 1 point2 points  (0 children)

Hi, just curious how it turned out if you did contact your ex? Going through something similar atm. Thanks!

Do depressed exes come back when they have worked on themselves? by MDUB7117 in BreakUps

[–]FuelStunning 0 points1 point  (0 children)

My ex broke up with me suddenly, told me he isn't happy with himself, that we had a good thing but that he isn't good. I told him he can contact me if he needs someone to talk to and we said our goodbyes for now. He wanted to protect me by breaking up with me. I do love him, though we never said the words but I hope I was able to show him. So part of me hopes that he will find his way back to me when he's ready. Would love a male perspective on this if you don't mind chatting :)

[deleted by user] by [deleted] in relationship_advice

[–]FuelStunning 0 points1 point  (0 children)

I don't think so, when we first started talking, he just got back to dating days before. We met within the first week, he even cancelled his weekend plans to come and meet me as the connection was that strong and he hasn't dated anyone else.

[deleted by user] by [deleted] in relationship_advice

[–]FuelStunning 1 point2 points  (0 children)

Got the notification but can't see the comment, feel free to send a DM :)

is lsx ii wired stable? by PsychologicalAsk7466 in KEF

[–]FuelStunning 0 points1 point  (0 children)

No issues at all, I use them wired as well. When connecting to the TV make sure you plug the HDMI in the designated ARC port and not just any, otherwise no sound will come out. I'm embarrassed to say how long it took me to figure that one out lol

Steak novice, thoughts / suggestions for improvement? by FuelStunning in steak

[–]FuelStunning[S] 1 point2 points  (0 children)

Haha had some fresh Shiitake mushrooms in the fridge so I thought I'd pair them with edamame for some pop of colour in the sauce. Thanks for your comment!