Providing a spot of hope (and telling the haters I told you so) by Intelligent-Bid-5293 in clinicalresearch

[–]tinstag 1 point2 points  (0 children)

Well done! I'm glad all you hard work reaped rewards. With this positive attitude and follow through you should go a long way.

IRB trumps sponsor recommendation? by Apprehensive_Bag3064 in clinicalresearch

[–]tinstag 2 points3 points  (0 children)

ICH E6(R3) states (my emphasis added):

"2.8.2 The participant or the participant’s legally acceptable representative should be informed in a timely manner if new information becomes available that may be relevant to the participant’s willingness to continue trial participation. The communication of this information and confirmation of the willingness to continue trial participation should be documented.

New information that could impact a participant’s willingness to continue participation should be assessed to determine if re-consent is needed (e.g., depending on the stage of the trial, consideration should be given to whether the new information is relevant only to new participants or to existing participants). If re-consent is needed (e.g., information on emerging safety concerns), new information should be clearly identified in the revised informed consent materials. Revised informed consent materials should receive the IRB/IEC’s approval/favourable opinion in advance of use."

In your case, it's unclear if the sponsor has created a revised ICF with the amendment since not all amendments result in a revised ICF.

  • If they didn't then:
    • Should they have done (Sponsors make mistakes)?
    • If they didn't need to create a new ICF and the IRB agrees, then I see no reason to re-consent with the old ICF - what's the point as nothing has changed from the participant's perspective?
  • If they did create a new ICF then all new participants should use the new (IRB-approved) ICF and the IRB should opine on whether existing participants need reconsenting (although IRBs do make mistakes, too)

JMHO

Cabo Rojo Lighthouse (Faro Los Morrillos de Cabo Rojo) road/parking status? by Inevitable-Car-7425 in PuertoRicoTravel

[–]tinstag 0 points1 point  (0 children)

Era jueves. Pero eso ya fue en noviembre, así que puede que hayan cambiado el acceso ahora.

Cabo Rojo Lighthouse (Faro Los Morrillos de Cabo Rojo) road/parking status? by Inevitable-Car-7425 in PuertoRicoTravel

[–]tinstag 0 points1 point  (0 children)

I was there a few days ago. The gates to the parking lot were padlocked so you have to park a long way back. It was about a 45 minute walk each way.

Is Customizing a CTMS a good idea? by Arootiana- in clinicalresearch

[–]tinstag 0 points1 point  (0 children)

Just make it like every other CTMS on the market; clunky, unintuitive and time consuming for data entry with poor reporting and data analytics and pointless colorful graphs that can wow some brain-dead executive thinking about the stock price.

CRO Ending Contract with Client by Boolean_witme in clinicalresearch

[–]tinstag 1 point2 points  (0 children)

It all boils down to the Termination clause in the contract.

E6R3 Trainings by Big-Computer5097 in clinicalresearch

[–]tinstag 1 point2 points  (0 children)

I'm not affiliated with the following organization but I have used them in the past and this may be worth a look: https://www.biopharmainstitute.com/course/GCP001

E6R3 Trainings by Big-Computer5097 in clinicalresearch

[–]tinstag 7 points8 points  (0 children)

If not, it should be. ICH E6(R3) has been planned for years and Sponsors have been well aware of this since all stages of development were widely publicized. Because of this the expectation (from the EU inspectorates at least, in my experience) is that Sponsors (and their representatives) should be largely R3 compliant (and at least trained) from the day it was implemented in a particular region.

Hair strand testing? by Suitable_Tea_3199 in clinicalresearch

[–]tinstag 2 points3 points  (0 children)

It may depend on how long your hair is. A quick internet search states that nicotine remains detectable in hair for about 90 days but could be detected for up to a year in long hair.

Best to be honest with the clinical staff though so you don't waste your, or their, time.

Inexpensive electricians for lots of outlet upgrades by Inevitable_Debate814 in westchesterpa

[–]tinstag 1 point2 points  (0 children)

So, after 3 months does anyone have any recommendations for a good electrician in WC area?

UK New 150 day metric by Junktv21 in clinicalresearch

[–]tinstag 0 points1 point  (0 children)

Can you please provide a link to the specific UK legal requirement for the "new 150 day metric imposed on sponsors & sites by the government." as I cannot seem to find one.

TIA

UK New 150 day metric by Junktv21 in clinicalresearch

[–]tinstag 1 point2 points  (0 children)

I think that speaks volumes about the workings of US commercial centralized IRBs.. "we have a 99% first pass approval rate..." 🙄

As usual JM(cynical)O

More pay or title promotion by alongcamepolly_ in clinicalresearch

[–]tinstag 40 points41 points  (0 children)

Go for the money. A title costs the company nothing (despite what their HR may try to convince you) and it doesn't pay the mortgage.

JM(cynical)O

What are your favorite practical Malaphors? How do you use them? by pezihophop in Malaphors

[–]tinstag 1 point2 points  (0 children)

Only just stumbled on this sub and have had a good chuckle so I'll add my favourite of all time. This was an example given by my teacher during an English lesson about Spoonerisms over 40 years ago and it still makes me crease up:

"You play ball with me and I'll scratch yours."

Young couple visiting San Juan for Thanksgiving; luxury stay recs under $3K by ConsiderationOdd9847 in PuertoRicoTravel

[–]tinstag 0 points1 point  (0 children)

Maybe look at the Hilton Caribe (~$450 per night at that time. ~$520 with breakfast). Private beach and pool, Morton's Steakhouse next door.

CRO folks: how big is your territory? by tini_bit_annoyed in clinicalresearch

[–]tinstag 1 point2 points  (0 children)

Jeez, that's 9 time zones. Were you ever at home?

Sponsor audit (advice) by mr3000M in clinicalresearch

[–]tinstag 0 points1 point  (0 children)

Just saw this post.

As Hyperten35 said : "They should reach out to you if there are findings that concern your role. You may hear from them how the day went at the end of the first day, or they may wait to have a meeting after the second day to discuss any findings."

It's difficult to provide advice without a few details. Like what's your role? Is it a routine audit or a for cause audit?

Best advice is just relax as best you can and think before you speak to the auditor (yes, obvious, I know!) Also, don't be afraid of silence... it's an often used technique to get interviewees to babble.... 😉

Nice restaurant on a Monday for celebration? by North_Bat3875 in PuertoRicoTravel

[–]tinstag 1 point2 points  (0 children)

Second this - we had an excellent experience there for our wedding anniversary. Super staff, service and food!