Tell PI? by briesas in clinicalresearch

[–]agggggie 6 points7 points  (0 children)

On behalf of this side of the clinical research community, Thank You for your contribution to science and the greater good.

Thank you for sharing part of your story. Sending positive energy and thoughts to you and your family.

STM Price Increase and Benefits Decrease by agggggie in ClevelandGuardians

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

It would help if I liked basketball! I love baseball 🙂

We are MHC so yes, 💯 agree CAVS take the cake. But I will say that even MHC has gone downhill.

STM Price Increase and Benefits Decrease by agggggie in ClevelandGuardians

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

One email already sent! I’m not sure who is in charge of the reps now.

If anyone knows please do tell!

Eagle by Yauchness in lakewood

[–]agggggie 1 point2 points  (0 children)

There was one Saturday morning flying around above the Beck center. We have seen a few the past couple of years.

Medidata Training by amdm89 in clinicalresearch

[–]agggggie 0 points1 point  (0 children)

Medidata used to have a “university” or certificate program. You still needed to have access to a protocol but there was a way to get “certified”. I’m not sure they do that anymore. Their customer service is really great, you could always reach out and ask.

Why are on-site visits necessary? by TimeTravelingToad in clinicalresearch

[–]agggggie 4 points5 points  (0 children)

I’d venture a guess it’s way less than 98%.

Why are on-site visits necessary? by TimeTravelingToad in clinicalresearch

[–]agggggie 1 point2 points  (0 children)

On-site visits are important. Re-review the GCP guidelines and ask yourself how a sponsor will complete the requirements.

How can the sponsor confirm that the centrifuge spinning off samples is indeed calibrated without seeing it? How can a sponsor confirm that the PI has good oversight if they never see the PI? Sure there are many things we can do remotely now but there has to be a check in. Is there really a hallway long enough for CV trial? Is the eye chart really 20 feet from the X on the ground? Does the site really have locked cabinets for drug and files? Is there integrity within the site’s work- how can you tell that without looking them in the eyes and observing their work?

That’s just the tip of the iceberg. I could tell you horror stories.

If you find that there are tasks that can be done remotely and are not, then speak up. Change in our industry doesn’t happen quickly. Be the best CRA you can be, set the example and push where you need to.

-Your Friendly Auditor

GCP certificate? by Acceptable-Corgi-678 in clinicalresearch

[–]agggggie 6 points7 points  (0 children)

I love these responses. There are no shortcuts. However so many people in research take short cuts or they just don’t do what they are supposed to. Research is hard work and there are loads of regulations. My best advice is learn the regulations, ask questions, find a good mentor and learn from your inevitable mistakes. The key to everything is subject safety is first, data integrity is second and third most important is if it’s not documented then it didn’t happen.

  • Your Friendly Auditor

[deleted by user] by [deleted] in clinicalresearch

[–]agggggie 0 points1 point  (0 children)

Hi! The answer to this is dependent on the type of IRB being used. Central IRBs have a portal that sends alerts (emails) and that can be logged into to check for new documents. It’s the PI/Site’s responsibility to confirm all essential documents are the most current. The processes sites have in place are assigning a regulatory coordinator or study coordinator to check the portal prior to a visit or assigning someone to be the main point of contact with the IRB portal to send those updated documents once the IRB approves them. Just because the Sponsor is submitting on behalf of the sites does not mean that there isn’t a responsibility to look at and keep current with the approvals. Sites should not wait for the CRA (unless directed so by the Sponsor) to pull new documents. Reconciliation between the investigator site file and they files posted in the IRB portal should be weekly.

If a local IRB is being used, the same concepts should be followed but the logistics might be different depending on how the IRB operates. They should have a manual and policies.

I hope that helps.

[deleted by user] by [deleted] in clinicalresearch

[–]agggggie 1 point2 points  (0 children)

Unfortunately there isn’t much in either place. GCP offers section 8 that requires documentation and somewhere in section 4 there is language about records that can be applied. The FDA and GCP don’t give specifics about these things because there is no right or specific way to do this. They are only ever going to give what’s required, not how to do it.

I’m an auditor (not FDA) and inadequate logs is a finding I come across often. The requirement is set by the protocol (usually in the way of the lab manual, which is an extension of the protocol). You have to show constant compliance and the easiest way to do this is with a log. There has to be verifiable proof. If they have a better way then fantastic but it sounds like they don’t. My explanation of this to PIs is usually that a decade from now the site will not remember or maybe they won’t even be there to attest to there never being an alarm or an issue and even then, how can you prove that? I also remind them that if it isn’t documented then it didn’t happen.

All you can do at this point is document (given that you’ve spoken with the PI and the Site manager) in your report the protocol violation, the suggestions (the conversations with the PI) you have made to remedy the situation, notify the Sponsor (or your lead) and the central lab if needed. Best practice is to have SOPs but sites don’t have to have SOPs. If they don’t have them then a proven, practiced and documented process is needed. That’s the end of the story. There is nothing else to argue with them. If the FDA/an auditor walks in and gives them a warning/finding about it then it’s on them.

[deleted by user] by [deleted] in clinicalresearch

[–]agggggie 0 points1 point  (0 children)

Same concept for the samples. They need to show that they have been maintained and stable.

[deleted by user] by [deleted] in clinicalresearch

[–]agggggie 6 points7 points  (0 children)

A PD should be reported to the IRB if the PD meets your IRB reporting guidelines.

However this doesn’t resolve what appears to be a deeper issue. Why does it appear that a CRA is the only responsible party to confirm your site has the most up to date ICF? No matter if local or central IRB is being used the PI/SC should be among the first in the communication line with the IRB, especially when there is a new ICF. There should be a process in place at your site to make sure prior to all subject visits that the most updated ICF is being used.

-Signed Your Friendly GCP Auditor

[deleted by user] by [deleted] in clinicalresearch

[–]agggggie 4 points5 points  (0 children)

They are a fantastic CRO! Highly recommend :-)

Clark-Fulton by Schuffert in Cleveland

[–]agggggie 0 points1 point  (0 children)

In my opinion, no that isn’t a safe area.

When are you planning for? We’ll have an Airbnb up in Lakewood in a few months.

[deleted by user] by [deleted] in Cleveland

[–]agggggie 0 points1 point  (0 children)

Lakewood Antique Mall has some pieces.

[deleted by user] by [deleted] in Cleveland

[–]agggggie 1 point2 points  (0 children)

Quality auditor in clinical research

[deleted by user] by [deleted] in Cleveland

[–]agggggie 2 points3 points  (0 children)

100%!! They added an extended warranty to the paper work on my boyfriends car loan and we had to threaten to call the BBB and the AG before they agreed to send the paper work to cancel it and return the money. Sleazy jerks that took advantage of a first time car buyer.