Spring came early to Pennsylvania this year in one of those it is 40 degrees on Tuesday and 80 on Wednesday temperature shifts. This usually elicits the typical responses from people depending on your age. For the younger generations this usually means the start of flip flop season, which in case you hadn't figured out does not include me. I wear flip flops in public showers and at the beach. For me, it is more about cleaning - both at home and at work. I won't bore you with my domestic activities but I do have something interesting to share that is work related.
I have an extra white board in my office that has been sitting behind my door for a couple of years now. It hasn't been erased since 2005 and in fact cannot now be erased with applying toxic substances. What is written over more than half of it are notes about the electronic Common Technical Document (eCTD). There are questions to ask the eSUB office, items to address internally and things to think about. Here is the verbatim list:

1. RA Review of STFs - when?
2. ECGs - do they get a site ID attribute? Do they get cross referenced in the STF?
3. What is FDA's definition of short/medium/long?
4. Excipient attributes
5. Module 2.3 - attributes and granularity
6. Nesting of Bioanalytical reports - how to handle?
7. IND List of Investigators - lifecycle?
8. NDA to IND cross referencing
9. xpt filesize

Here are the "answers" we have come up with and as I do with all my cast off household and clothing items - if you can use great, if you want to pass along great, if you want to ditch great…

1. Reg Affairs reviews the short names/leaf titles and tags after the STFs are created but before the index.xml gets made so that we aren't constantly rebuilding. At least for large original applications, for shorter daily submissions that don't take long to create, it can be done during the overall metadata review.
2. Try to avoid submitting ECG waveform files - there are going to be lots of them and they all need to be tagged. Instead use the ECG warehouse, info is here:
   https://www.ecgwarehouse.com/index.php
3. There is no FDA or ICH definition of short/medium/long as it is therapeutic area specific and sponsors should come up with their own definitions.
4. We have adopted an industry best practice of grouping compendial excipients as one "type" and separate 3.2.P.4 sections for all non-compendial, named excipients.
5. Module 2.3 continues to be the source of much debate specifically around it's granularity and certainly around lifecycle. You could write a book on it…wait someone has! Consult the Regulatory Book of Knowledge for more advice:
   http://www.iriss-forum.org/wp-content/plugins/wp-download_monitor/user_u...
6. Bioanalytical reports that are "nested" within the appendices of PK reports, which are nested in a study report need to referenced separately in tabular presentation of studies and if possible submitted as standalone reports. In the event that they cannot, due to signoffs etc then at least hyperlink those references directly to the reports so reviewers can locate them.
7. We recommend updating and replacing the List of Investigators with each new investigator packet so that at a glance both sponsors and FDA can see who is participating in the study. Also, make sure it matches what is entered into clintrials.gov!
8. It is best to do a "mini-pilot" to confirm with the agency that this is possible, but this is where the big payoff is for all parties concerned!!!
9. Thanks FDA for increasing the maximum file size for xpt files to 400MG for non-standardized/legacy and analysis datasets and for having no limit for SDTM datasets.

That is it for me…now to the closets!