Gah! Hours and days of work, down the flusher.

I’m sooo ready to stick my head through my office door. Which door is 1.5"-thick maple. But I bet, if I beat my head against it as hard as I want to, I can get my head right through it. Maybe in a single go, even.

I’m a clinical publisher… that means I take scientific reports on medications, investigational and approved both, and assemble them for submission to, and use by, various regulatory agencies around the world. These reports have to be perfect, or so nearly perfect that no nit-picky scientist or statistician at an agency can find fault with the report’s assembly. These reviewers are busy people, and can’t be bothered with figuring out where something in a report is - either they can find it, right away, or they send the report back, along with a nastygram, and put that drug’s review at the back of the queue. This is legitimate - They’ve got MASSIVE reports to read, and LOTS of them… All are complex and incredibly detailed - So they don’t have time to play “Where’s Waldo” with data, listings, and tables.

In addition to the careful detail on the assembly, these reports have to be COMPLETE - no missing parts, no “we’ll get it to you later,” unless specifically agreed in advance with the reviewer. They agency needs final reports on all studies, even if a drug fails or is withdrawn - If you get a bad safety profile, for instance, in trials, the agency still wants to hear about it, even if you’ve zero intention of doing anything else with that drug, ever again. If you find that the drug is no better than existing products, and whilst safe, is simply uneconomical to market, the agency still wants to know about the trials that convinced the pharma of this. So on, so forth, yadda, yadda, yadda.

So, I assemble reports. Big ones, little ones, and honkin’ great giant ones. Like this one I’m working on right now - a size-mongo trial on a drug that ultimately failed late in development. In excess of 68 thousand pages. Not a typo: 68 kilopages. The trial report has been written by at least three people. I can tell - there are distinct differences in styles when referring to tables and appendices. None of those people are currently assigned to this project, because, well… it’s dead, Jim.

There are problems with the report. Typos that alter scientific meaning. Missing documentation. Mis-labeled tables. Due to the nature of how the material is gathered and assembled, many of these problems don’t show up until a LOT of work has already been done. Some can be corrected on the fly, or without huge rework. But sometimes, the pagination changes, or the entire content shifts by a line or two. When that happens, literally thousands of links and bookmarks are thrown off, and the navigation that the reviewers need, rely upon, demand, is lost. Gone. Wasted. Thrown out the window. Along with those navigational aids, goes my work. Hours and days of it. 10-, 12-, even 15-hour days trying to close this report out… Shot to shit.


Three times, now, this has happened with this report. And the people I need to contact, so I can begin, once again? They are all on vacation, goddamit.

Where’s the aspirin? My door is going to need some when I’m done with it.

:confused: The other stuff (typos etc.) I can understand, but not this. Are you somehow not using a system that automatically maintains links and bookmarks?

The links and bookmarks are moving across multiple documents, and whilst many have auto-maintenance, many others do not, especially those pointing to locations on scanned documents.

Further complicating matters, some of the documents are internally created, and some are from outside sources, so not all are using the same conventions.

Holy crap. And I bitch about maintaining manuals of a few hundred pages.

Well, in fairness, most trial studies measure in the mid teens of thousands of pages - not exceedingly difficult, so long as the study delivery team did a halfway clean job. But this one is a cast-iron bitch with sand in her undies.

Thank goodness its report wasn’t a 68 kilopage clusterfuck.

Wow, Tranquilis. Wow. That’s just… wow. This is one of those rare gut-level pittings that leaves you really feeling the OP’s pain. I cannot begin to comprehend the weight on your shoulders with respect to this thing, and I’m helpless to assist you in any way. Man, I just hope it turns out okay, and I hope you’ll never encounter one like it again.

Oh, geeze. I spent one year as a baby technical writer, and 100 page documents made me cry.

What kind of software do you use? I know MS Word isn’t any good beyond about 500 pages. It just gets too flaky. Framemaker? Something else?

At any rate, you have my deepest sympathy. If you’re anywhere near DFW, I’ll take you out for a drink.

You don’t need aspirin, you need a bottle of Jack!

That’s not aspirin bad, that’s book depository bad.

Hope you don’t have plans for Chistmas '08.

You only think you jest… Aspirin is a weird compound. It does a lot of different things. If it weren’t already grandfathered as “generally accepted as safe,” a trial on it might well turn out to be a multidecakilopageclusterfuck.*
Thanks, Liberal… It helps to scream here, as I can’t do it in the office. Too many people would be a-feared that I’d taken tdn’s comment seriously…

Core text is Word. There are 27 major components, each a concatenated compilation of lesser documents. Data tables are SAS output pulled via an interpreter into a *PDF. Figures can be TIFFs, Word, or scanned - all converted to PDF. Add scanned documents liberally throughout. Ensure that house style is violated often. Require that half of the scanned pages be outside the printable margins, and that page sizes are a mix of US Letter, A4, and some random standard imported from Lower Elbonia.

Further, ensure that all fax transmittals and most signature scans are run through an archiving system that fails to index correctly, and turns text into large opaque blobs.

Import the entire mass into a Documentum-based customized Doc Management system. Render all documents via Acrobat. Yes, folks, pity me - Acrobat is our PDF assembly application. Link, concatenate, and assemble as best you are able, whilst trying to shoehorn the resulting mess into a semblance of house style.
Alas, I live in the Mid-Atlantic, or I’d take you up on that offer - If I ever had time to drink…

Heh! No doubt, but when would I have time to drink it? right now, i’m waiting for a ‘save’ to complete, but I’m also on the phone as I type this.

tdn, as it happens, I do have plans for Xmas '08… I’ll be completing a study report… Yeah, they’re planned that far out. And further.
Ya know, we do own a 30-floor tower here… Hmmm.

*TM, Patent Pending, etc .etc.

I sat next to people just like you for about a year at the last job. It didn’t sound like they were having much fun with it either. Oy.

Go to your boss, and tell him or her that you’ll be done with this some time next decade. I certainly would be. Then spend the next few years finding a better job, and jump ship and dump the misery on someone else.

68 thousand pages? And it’s a mess like that? Just spellchecking it properly would take months! Actually fixing style issues would take years!

The horrible(??) thing is, most days, I love my job - I get to see nifty stuff, learn how drugs and disease work, particpate in bringing to life drugs that will help improve lives, save lives, restore normal function to people’s lives, and it’s cool.

I see pediatric trials on my primary drug that, had the effect been known five years ago, would have saved both of my nephews a LOT of grief - My sister would’ve been saved grief, fear, and doubt too. OK, so it’s too late to help them out (they’re having to do things the old-fashioned way - fixing after the fact), but whole generations of kids in the future will benefit from the science that crosses my desk. And not just from my drug, either - This science will become part of human knowledge, and once the studies are published, you can guarantee that others will be digging into it, looking for more, newer, better ways to do the same thing. The motive is largely profit, sure, but the end result is better life for the affected children. We lead the way, open the door, but the door doesn’t close behind us - lots of others will follow the path we’re blazing now, widening it, improving it, taking it new places. That rocks! For that,I’ll gladly suck up the pain.

But this drug? It’s dead. It isn’t going to be of large benefit. It’s part of human knowledge now, but it’s a dead end, or at best a footnote and reference. Maybe someone will mine the data and learn something unexpected and exciting, but that’s not any guarantee. Right now, it’s just an albatross, hanging 'round my neck - stinking and keeping me away from the cool studies. And being a pain in the ass to boot. If it were going forward, I could justify all the pain by telling myself that patients will be helped, money made, new possibilities opened up. But no - I’m merely cleaning up after the party is over. And the party ended badly anyway.

68,000 pages?

The Verve managed to say basically the same thing in four words.


Heh! So they did… But the Verve didn’t say why.
We need to know why. The agency wants to know why. Our stockholders deserve to know why. The patients who were hoping for this drug are owed a “why.”

The “why” is in this mass of documents, currently doing it’s damnedest to remain anonymous.

Good lord, I thought I was the only one left trying to make use out of Word and Acrobat. Yup, everything has to be converted to PDF. I hate it. I would kill myself trying to work with a document that size.

Some day, they promise us, we’ll see eCTD and XML publishing. Honestly, they claim. Maybe even, they hint slyly, XML authoring to go with XML publishing.

They’ve been promising this for years now.

Meanwhile, the Doc Management administration budget has been slashed to the bone.

Uh huh. Yeah, call me the weatherman.

Wow, it kinda gives one perspective that the things they deal with at work are very, very mild. Just curious: what type of degree do you have?

No degree at all.

I worked my way in here by sheer “knowing what the hell I was doing.” Most of my fellows are BS or BA types, a couple have an MS and we even have a pair of RNs. Boss is an MBA. All of the people in my group are clued-in, hard-working, and fast-learning. It’s the Study Delivery people that are pissing me off.

Background is US Navy Submarine Reactor Operator, followed by various non-nuclear billets, followed by a stint as a Recruiter, followed by IT Consultant, then here.