When you are up to your ass in alligators, it is hard to remember you started out to drain the swamp.  And so it was with this series.  It grew out of a written "dialog" with CLM on philosophical issues relating to the organization and operation of treatment effects monitoring committees.  A memo dated 26 April 2000 from CLM entitled Treatment effects monitoring in clinical trials caused me to set about writing, what I considered to be, good policies and practices for the Center in regard to treatment effects monitoring.  It gave rise to a related memo detailing, what I regarded, IRB good practice policies and procedures, and the series was born.

The series was produced over a period of 9 months starting with the distribution of the two memos mentioned above at mid year in 2001.  In all, a total of 40 memos were distributed as listed on the page above.  The dates on the memos themselves correspond to dates when the memos were born in some cases and in others when they were in nearly final form.

Once I had waded into the swamp of GPPPs for the Center, I realized the swamp was bigger than I had thought.  By the time I realized that I should have had a map marking the lily patches I wanted to visit, it was too late.  I had wandered too long map-less, so I just kept wandering until I ran out of lily patches I considered worth visiting.  No doubt, were I to be foolish enough to wade back into the swamp again without a map, the resulting series would be different.

I am, of course, aware that together the GPPPs are redundant and sometimes even contradictory – an inevitable result of wandering without a map.  I am aware, as well, that I have been cryptic and that many of the P&Ps could benefit from more narrative, but one gets tired of wading in mud.  No doubt, my tendency toward crypticism and terseness increased with time in the swamp.

I have profited from Barbara Martin's input in reading and commenting on some of the early GPPPs and from Susan Tonascia's steady and trusted hand.  Susan has read the majority of the GPPPs and provided comments, corrections, and additions.  Thank you Susan!

I must also thank Betty Collison (Watson to me).  She has had the job of distributing the GPPPs and keeping track of the resulting mess.  Thank you Betty!