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Oct. 17th, 2006 02:53 pmI faxed an SAE to the company handling one of my slower accruing studies at 9:30 this morning. The person who reviews all incoming SAEs calls me at 1:30 to tell me that their company form has changed and could I please do the SAE over? Oh, you mean, the SAE that is due, by our institutional standards, today at 4:40pm? I'm sorry? Yes, I understand there is a time difference, with you out in California, but you're just telling me this at THREE HOURS BEFORE IT'S DUE?!
WTF?!
So I'm sure, dear flist, you are looking at this and going, dude, what's the problem? Just do it over again. But you have to understand. SAEs are a bitch and a half, people. I equate it with getting a root canal whilst hanging from my fingernails. First, there are the forms. They take time, especially since most have to be handwritten, and they are all company specific. On top of that, you have the added anxiety about making a mistake because if you do, you have to cross it out and initial and date it, and the format of these things is universally cramped.
Then the forms have to be reviewed by the study manager. Any changes s/he requests have to be worked in. (In the case of one of my more special study managers, I ALWAYS have to send multiple follow up emails to the SAE form he sends me, because inevitably, he's forgotten something. It never fails.)
Finally there is the odious task of finding a doctor to sign the finished product. This is further complicated by the small matter of the 1572. This is a legal document sent to the FDA stating particulars about the PI (primary investigator - aka, the guy who gets his name first on the paper) and any of the doctors included as Co-PIs. The SAE must be signed by one of the doctors on this document. No exceptions. As the afternoon is clinic time for most docs and morning encompasses rounds, meetings, etc., or God forbid, s/he's the attending on call for inpatient, it is sort of like the experience I had revisiting Yellowstone this summer - futile, I didn't see any elk or moose, and ended on a very rushed, very bumpy note.
Needless to say, it's a fucking hassle tracking down the PI, let alone a co-PI. So when I went to my supervisor to explain, she flat out said no, and then we went to her supervisor, and she said no. Multiple times. Not only is our doctor out of town until next Tuesday, but she said it was unacceptable for me to have to duplicate my work.
Which, YAY!
[eta]I emailed the company to tell them no to which they replied (what else?) OK. My supervisor just emailed me in response to that and I quote, "Great - you go girl!" Hee! My boss for the win, folks. Seriously.[/eta]
WTF?!
So I'm sure, dear flist, you are looking at this and going, dude, what's the problem? Just do it over again. But you have to understand. SAEs are a bitch and a half, people. I equate it with getting a root canal whilst hanging from my fingernails. First, there are the forms. They take time, especially since most have to be handwritten, and they are all company specific. On top of that, you have the added anxiety about making a mistake because if you do, you have to cross it out and initial and date it, and the format of these things is universally cramped.
Then the forms have to be reviewed by the study manager. Any changes s/he requests have to be worked in. (In the case of one of my more special study managers, I ALWAYS have to send multiple follow up emails to the SAE form he sends me, because inevitably, he's forgotten something. It never fails.)
Finally there is the odious task of finding a doctor to sign the finished product. This is further complicated by the small matter of the 1572. This is a legal document sent to the FDA stating particulars about the PI (primary investigator - aka, the guy who gets his name first on the paper) and any of the doctors included as Co-PIs. The SAE must be signed by one of the doctors on this document. No exceptions. As the afternoon is clinic time for most docs and morning encompasses rounds, meetings, etc., or God forbid, s/he's the attending on call for inpatient, it is sort of like the experience I had revisiting Yellowstone this summer - futile, I didn't see any elk or moose, and ended on a very rushed, very bumpy note.
Needless to say, it's a fucking hassle tracking down the PI, let alone a co-PI. So when I went to my supervisor to explain, she flat out said no, and then we went to her supervisor, and she said no. Multiple times. Not only is our doctor out of town until next Tuesday, but she said it was unacceptable for me to have to duplicate my work.
Which, YAY!
[eta]I emailed the company to tell them no to which they replied (what else?) OK. My supervisor just emailed me in response to that and I quote, "Great - you go girl!" Hee! My boss for the win, folks. Seriously.[/eta]
