One Q & a Lotta A’s about SOPs for Research Sites

By Laurie Meehan

Posted on LinkedIn in July:

“What are your thoughts about having SOPs for clinical research sites versus having working guidelines in lieu of SOPs?”

You know how it is with those LinkedIn discussion groups.  You think you’re posting an intriguing and brilliantly conceived question that will inspire your colleagues to clear their desks, seize their keyboards, and plunge headlong into enthusiastic electronic debate.  Instead, your post lands unceremoniously on the ground, with only the dullest of thuds, ignored and unloved.  So naturally, when I encountered the post above -- which had managed to attract 32 responses -- I was curious to see what had garnered such attention. (And yes, that was 3 months ago and I’m just getting around to writing about this now.  Don’t judge me.)

The Plain Writing Act of 2010: Lessons for Industry

FDA and other federal agencies are bound by the Plain Writing Act of 2010 to use “clear government communication that the public can understand and use.”  It seems ridiculous that we’d need legislation for such a thing, since “understandable” and “useful” are such obvious and fundamental attributes of communication.  There’s even a companion document, the 118-page Federal Plain Language Guidelines (FPLG).

Be us not, in industry, too smug.