Great work! Thanks, Mario for sharing your experience with dealing with those five different types of problematic site-sponsor relationships. As a junior CRA, I am eager to learn everything from you about how to handle a difficult relationship with the site.
Thank you very much for taking the time to make this. I am learning a lot from your videos. Keep up the good work, you've gained another subscriber . 😀 Stay blessed 🙏🏽💙🙏🏽
Thank you Mario, I take a lot from your videos that I only discover today. I have been both blinded and unblinded CRA so the story on the IP accountability made my jaw drop hahaha...I have been dealing for the past 2 months with a very incompetent study coordinator, who has been delaying tasks and deflected responsibilities, in getting RGO approval done, PICF approved, CTRA finalized, and providing all Essential documents, which to this date she still has not supplied, how do you deal with keeping your patience in check when sites are so unresponsive, the PM and the sponsor are aware of the situation, but nothing gets her to do the job and is only delaying the time to FPFV. The sponsor has decided to go to SIV without any of these documents, No RGO aprvl, no CTRA, no PICF approved. I have not yet mastered how to get my head around this complete lack of steps and processes that are supposed to be followed prior to SIV. They even did the SSV without a CDA in place. Thanks Mario.
Hi, thanks for checking out my videos. I think in the case you're describing it's best to make your opinion known to the study team and ask the PI what can be done to support their site. Make sure you document everything and all the attempts in telephone/email contact reports. Try and find out the root cause of why things aren't getting done. Some times it is incompetence and some times it's SCs being spread thin across many studies. It does sound like the sponsor is making it worse by proceeding with things even though documents aren't in place. An SSV shouldn't happen without a CDA and a SIV shouldn't happen without essential documents being provided. I would very clearly communicate to the study team that you think proceeding with these visits is a bad idea because it'll be even harder to get them after the visit. Your job is mostly to make sure all the issues are documented. It's not to stress out about a site that can't provide things. I'd prioritize other work and hope for the best with the site and let them know you're available to support them if wanted.
Great work! Thanks, Mario for sharing your experience with dealing with those five different types of problematic site-sponsor relationships. As a junior CRA, I am eager to learn everything from you about how to handle a difficult relationship with the site.
Thank you very much for taking the time to make this. I am learning a lot from your videos. Keep up the good work, you've gained another subscriber . 😀 Stay blessed 🙏🏽💙🙏🏽
Thank you for the support. Much appreciated!
Thank you Mario, I take a lot from your videos that I only discover today. I have been both blinded and unblinded CRA so the story on the IP accountability made my jaw drop hahaha...I have been dealing for the past 2 months with a very incompetent study coordinator, who has been delaying tasks and deflected responsibilities, in getting RGO approval done, PICF approved, CTRA finalized, and providing all Essential documents, which to this date she still has not supplied, how do you deal with keeping your patience in check when sites are so unresponsive, the PM and the sponsor are aware of the situation, but nothing gets her to do the job and is only delaying the time to FPFV. The sponsor has decided to go to SIV without any of these documents, No RGO aprvl, no CTRA, no PICF approved. I have not yet mastered how to get my head around this complete lack of steps and processes that are supposed to be followed prior to SIV. They even did the SSV without a CDA in place.
Thanks Mario.
Hi, thanks for checking out my videos. I think in the case you're describing it's best to make your opinion known to the study team and ask the PI what can be done to support their site. Make sure you document everything and all the attempts in telephone/email contact reports. Try and find out the root cause of why things aren't getting done. Some times it is incompetence and some times it's SCs being spread thin across many studies. It does sound like the sponsor is making it worse by proceeding with things even though documents aren't in place. An SSV shouldn't happen without a CDA and a SIV shouldn't happen without essential documents being provided. I would very clearly communicate to the study team that you think proceeding with these visits is a bad idea because it'll be even harder to get them after the visit. Your job is mostly to make sure all the issues are documented. It's not to stress out about a site that can't provide things. I'd prioritize other work and hope for the best with the site and let them know you're available to support them if wanted.
Try doing a study’s worth of IP accountability at a COV.
Been there, done that. However, I'm usually not told that everything is perfect in those circumstances.