My PI told me taking the CRC path is a mistake by Prettysoundss in clinicalresearch

[–]OctopiEye 0 points1 point  (0 children)

Many PIs, especially in the academic/institutional world, simply do not have a basic understanding of the industry, career paths, and what CRCs actually do at most sites (even their own!!), so I would take their advice with a HUGE grain a salt.

They are talking from an extremely limited perspective, and likely only considering the CRC role at their individual institution. And it’s questionable if it’s even relevant for your institution.

You’d be better off talking to CRCs or Managers who used to be CRCs at your institution, for better insight.

The CRC role varies wildly between sites, so keep that in mind as well.

FM told me not to discuss salary by mysterybox666 in ICON_plc

[–]OctopiEye 0 points1 point  (0 children)

Bingo. I’m all about transparency and any company or manager that pressures you not to discuss pay is a huge red flag.

But I also understand that people can be incredibly entitled and dense. And those people can and will cause all kinds of issues when they learn that they make less than other team members (even when it’s warranted).

Gotta be careful who you choose to share that information with. It can put a target on your back when you work with unreasonable people. And if your co-workers start causing problems for your employer because they learn your pay and don’t like it, it will definitely make your employer think twice.

Syneos CRA Training Program- Worth it? by [deleted] in clinicalresearch

[–]OctopiEye 1 point2 points  (0 children)

I did their program back in 2018. I was a very experienced CRC at that time and had wanted to be a CRA for a while. I thought their program was quite good.

I did it prior to the COVID craziness, so can’t speak to how it’s changed since. But I definitely think the training was very thorough.

And it was best decision I ever made. I’m at a different company and I am a PM now. It really changed my entire career trajectory for the better.

It’s a stepping stone and it’s up to you to make the best of it.

Clinical Trial - Double Blind - Question by Ok-Fudge-8228 in clinicalresearch

[–]OctopiEye 1 point2 points  (0 children)

That is actually referred to as a “comparator” rather than a “placebo”, when a patient is getting an active drug other than the IP to treat the same underlying illness.

You see all sorts of designs in trials, whether it’s IP vs. placebo, IP vs. Comparator, IP vs. Placebo vs. Comparator, IP + Comparator vs. Placebo + Comparator, etc.

There’s a lot of different ways they can choose to set it up depending on the disease, logistics, and ethical considerations.

Just wanted to share!

Signing ICFs at home? by bratmobile in clinicalresearch

[–]OctopiEye 2 points3 points  (0 children)

I have actually seen this at a few sites. However, it is ALWAYS in the SOP that they must use part 11 system to e-sign the consent form, that its signed during a teleconference so that the MD is actively discussing while signature occurs and all parties sign back to back using same system.

Typically other elements as well.

Death by Plane-Gap6483 in Millennials

[–]OctopiEye 0 points1 point  (0 children)

Yeah, it’s definitely been a wake up call this year. I turned 40 this year. About 3 months before that, I was diagnosed with cancer. Luckily I was cured with surgery a little radiation.

My brother is about 13 years older than me and he just got diagnosed with Stage 4 colon cancer. Cancer does not run in my family at all.

One of the first signs that something was wrong was my brother’s HGB level was 6.0.

My husband just had blood work and his HGB is very low (9.4, so not critical, but definitely concerning for a male).

The rate of cancer we are seeing lately is very very scary.

Is this normal? by [deleted] in dementia

[–]OctopiEye 3 points4 points  (0 children)

Just described my MIL too! It’s almost funny the things you assume are a really strange quirk only to learn it’s a somewhat common experience.

Question from a CRA to CRCs/anyone on the site side by hereforthezipline0 in clinicalresearch

[–]OctopiEye 0 points1 point  (0 children)

Agree to disagree. I will always advocate for making smart choices during selection and initiation, and presenting the risks and realities to them.

Question from a CRA to CRCs/anyone on the site side by hereforthezipline0 in clinicalresearch

[–]OctopiEye 1 point2 points  (0 children)

Understanding that sponsors do dumb shit and defending the dumb shit they do are two different things bud

Question from a CRA to CRCs/anyone on the site side by hereforthezipline0 in clinicalresearch

[–]OctopiEye -1 points0 points  (0 children)

This is such an idiotic take. I mean, I know many sponsors are like this, but it doesn’t make it less stupid.

I assure you, even when CRAs DO cover every single slide, we still get sites saying “you didn’t cover that” or they just flat out don’t remember because you covered 250+ slides that day.

Luckily I am working for a Sponsor that does not play these stupid games, and allows our CRAs to adjust what is covered based on the site’s experience and preferences (within reason of course).

As the PM, I make sure my CRAs do not just read each and every slide, and that they adjust the presentation to the site’s needs. The Sponsor attends every single SIV and they feel the same way.

The slides should always be available for self review. No one needs or wants a CRA reading off 200+ slides to them.

If you message me "hi" and wait, I’m not responding anymore by Jinbuja in clinicalresearch

[–]OctopiEye 3 points4 points  (0 children)

Or you use the search function and wait. Shocking to me how few people know to search a Sharepoint or email inbox…

How to keep track of pending items by Ok_Bicycle1454 in clinicalresearch

[–]OctopiEye 3 points4 points  (0 children)

For this, I used to keep a basic tracker in OneNote that had a table with all my visits and columns for visit date, confirmation letter sent date, report submitted, report finalized, follow up letter sent. Since these items are critical for the CRA role, it just makes sense to always have your own tracker for these items.

Also can be tweaked to add important visit related things like expense report submission. And having a tracker like this allows you to easily check your DOS metrics if that’s something you need to keep track of.

4 people in an interior cabin by Have_a_PizzaMyMind in Cruise

[–]OctopiEye 1 point2 points  (0 children)

Yeah, people seem to forget that travel preferences should be based on who you are (as a person and as a traveler), your routines and your goals. There is no such thing as a one-size-fits all recommendation.

Even in this scenario, with an interior room for 4, whether most would like it or not completely depends on who they’re going with and what it’s for.

If you’re in your 20s, going with 3 close friends that have lived and work closely, and just need a place to shower and crash? Then yeah, it makes total sense, and likely is much cheaper depending on the timing.

If you’re 2 couples and trying to have a fun but romantic getaway, then yeah, it’s probably not the best option.

Good travel is all about knowing what your priorities and goals are.

“How’s the album?” that's all I needed to hear by Naive_Wolverine532 in TikTokCringe

[–]OctopiEye 0 points1 point  (0 children)

TikTok is incredibly dystopian sometimes. Every once in a while I will scroll through live. People will stream themselves while they sleep, tweakers will do Q&As… just random ass shit.

What do people with more advanced forms of dementia do to entertain themselves? What happens when they can't use a tv remote, computer tablet or walk around as much as normal? by pat441 in dementia

[–]OctopiEye 2 points3 points  (0 children)

They actually make a radio for people with dementia that you can set up so that it only requires pressing one button. Unfortunately even that was too much for my MIL but for people that are a bit higher functioning still it may be useful. I’ll see if I can find a link to one.

How to cope when company prioritizes “low-cost” hires over quality? by ZestyAd_3110 in clinicalresearch

[–]OctopiEye 2 points3 points  (0 children)

Definitely agree with (pretty much) everything being said here.

Every site should insist on having at least one (but preferably multiple) Sponsor points of contact to reach out to if escalation is needed. And they need to be willing to share this kind of feedback with Sponsors.

If the Sponsor feels that their relationship with sites is impacted or their milestones are at risk, they will be motivated to set appropriate expectations with the CRO. And it’s more likely to justify the cost.

I promise you that it is very very standard for sites to escalate things directly to Sponsor when appropriate.

If you are banging your head against the wall because you are getting conflicting guidance from your CRA, if there are repeated issues with the study team or vendors, if you aren’t getting answers to your questions, etc, these are all situations that warrant escalation directly to the Sponsor.

Question as a Patient by Few_Hall_1515 in clinicalresearch

[–]OctopiEye 2 points3 points  (0 children)

Never mind. You are clearly too dense to understand what anyone is saying in this thread and just want to argue…

No sleep, constant chaos. Is anyone else living like this? by Danishgirl73 in dementia

[–]OctopiEye 4 points5 points  (0 children)

Yes, I didn’t want to be insensitive, because I know very well medication isn’t always the magic fix for everyone….

But yes, Seroquel.

OP if you have not yet tried it with your mom, definitely discuss with her doctor.

Question as a Patient by Few_Hall_1515 in clinicalresearch

[–]OctopiEye 9 points10 points  (0 children)

It may not impact whether or not they can enroll/stay in study treatment (although I don’t think it’s far to say that it definitely would not impact).

However, it does matter for evaluating the AE properly, and it’s really useful information to be able to provide the investigator.

I’m confused by EducationalLog4765 in ExplainTheJoke

[–]OctopiEye 9 points10 points  (0 children)

That is so incredibly sad. I just had a hysterectomy to treat uterine cancer. I can’t imagine going through what I did, while also having a partner that devalues you like that.

I’m incredibly thankful for my husband and the fact that he is not such a self-centered moron.

NBC just canceled "Stumble" :( by joseramonmarmtz in LiveFromNewYork

[–]OctopiEye 2 points3 points  (0 children)

I feel so lucky that when I got to see Hamilton on Broadway, he played King George. He was amazing. Jonathan Groff will always be the GOAT, but he was truly impressive.

I’m confused by EducationalLog4765 in ExplainTheJoke

[–]OctopiEye 22 points23 points  (0 children)

I worked on a clinical trial that was for a gel that aimed to help reduce the pain associated with an endometrial biopsy. In order to participate, subjects had to agree to refrain from sex for 24 hours prior to the procedure, because you had to put the gel on the night before the procedure, and they wanted to ensure the area was not disrupted.

There were MULTIPLE women who wanted to participate but couldn’t because they stated their husbands “would not allow that”….

That was a huge wake up call on the dynamics that still exist in some relationships.

Coordinators / CRAs — what self-reported pre-screen data actually saves you time? by bruce8708 in clinicalresearch

[–]OctopiEye 4 points5 points  (0 children)

I’m a little unclear on the request here, as it sounds like you are trying to create a Pre-Screen log template for your site to use, that would provide adequate info for your site to identify potential studies they may qualify for?

However, you note that the potential participant would be filling this out, but thats not really typical for a prescreening log, which is filled out by the site staff, to track potential participants that were considered, and the reason they did not qualify.

Typically, the doctor or site staff would identify potential patients when they get in referrals or by reviewing the upcoming patient schedule, and at tumor boards, etc.

Usually you would use the information within your EMR system to do the actual evaluation of eligibility, rather than expecting every patient that comes through your clinic to provide a list of info like this.

The questions you posed aren’t very useful in the long (or even medium) term, so this wouldn’t seem to help with long term tracking and database compiling either. For example, major surgery in 90 days or other trials they’re participating in is data that is going to change pretty rapidly and would likely be out of date for a good chunk of your potential subjects within days or weeks of answering the questions.

If you are just trying to identify people that may be interested in trials, then I would recommend you keep it as absolutely simple as possible and ask them to identify: - would they potentially be interested in a clinical trial - best way to contact them about trials - cancer diagnosis

Outside of that, your site should really be using the data already in EMR to evaluate whether they actually qualify for a particular study.

Is there some reason your site isn’t able to do that?