I'm down to one study
However, this study has taken up much, very much of my time. First, we had a meeting (1 hr) about the study 3 weeks before it needed to be at our IRB in order to make a grant deadline. Normally, in this instance, we don't worry about the study being perfect, nor do we really worry about data forms, etc. because it has to be re-reviewed by the full scientific review committee and then re-reviewed by the IRB before its approved anyhow--plenty of time to fine-tooth comb it. But the grant submission requirements state that the study must be at our IRB by the grant deadline. Not reviewed, approved, etc--just physically THERE. I spent maybe 3 hours filling out paperwork, etc. for the initial admin. submission.
But then, two days before the grant deadline, the day I should have it to the sci review committee for administrative review, one of the co-investigators and the mentorning doctor on the study, has a cow and wants all kinds of nit-picky changes made regardless. (I don't think she really understood the issues involved.) She left a nasty voice mail on a Friday that I was working from home (time it took to listen to it, bitch about it, worry about it: 8 hours). I spent 6 hours working on data forms and another 3 hours making nitpick changes to the protocol. Sub total: 20 hours.
Then, we have to meet after it has been reviewed by the IRB--but first, some changes suggested by the doctor believing the protocol to be lice-ridden need to be made (this does not include the IRB changes). Another 3 hours, making those changes, creating nice tabbed packets of protocol/consents/forms/letters/etc. in order to make the meeting smoother. Then the meeting day arrives. We (the investigator and I) wait 30 minutes for the 3rd doctor. Then this meeting takes 2.5 hours. Sub total: 26 hours
Now, I'm in the process of fixing everything based on the meeting. I spent 2 hours working on the protocol yesterday. Another hour so far today (and this doesn't even include the bitching). We are now up to 29 hours and I still have an afternoon of forms editing to do, plus the IRB contingency letter to respond to and then the co-investigator must re-review over the weekend and I'll have to make last minute changes on Tuesday and do all the logistical work in order to submit. I'm thinking a minimum of 36 hours (gross) before submission. There will be more contingencies to answer after full-committee review. I'm going out on a limb and saying that it is likely that by the time this is all said and done, I will put in another 6-12 hours before the study is activated. This is 2 days of my life I will never get back.
And it really didn't have to be this hard.
I'm opening only 2 studies this month--I was going to open 3, but the third needs so much work and I didn't get it until last week, late, and the guy has had it since last Yom Kippur, so one more month isn't going to hurt--but I feel like it's a month where I'm opening 8.
I think I'm going to have to come in this weekend. I hate that.
And all I've done today is complain and bitch about people and phone calls. The copy/fax machine isn't working again. Because I sit in the office just next to it, people have asked me what's the matter with it. I actually don't know, since I haven't tried to operate the machine all day. Sooooo, I called Xerox (someone had to) and left a note on the machine. I also left a note hanging on the wall at the entrance of the hallway leading back here. Nevertheless, at least 3 people have asked me about it. One person, without any preamble, merely said, "What wrong wi't?"
I don't know.
What it doin'?
I don't know. It isn't working, I guess.
'Cuz sometime I can fi'it, if I know what wrong wi't.
I haven't used it.
Is it jammin' or sumpin'?
Or sumpin'. I'm fi't'n to go, 'scuse me.