Beauty Break

More CRA related posts soon but today I am off-topic and burning through some birthday giftcards and shopping online.  I am going to share some of my favorite beauty buys with you loyal readers, hope this will be of interest.


Can You Get Hooked on Lip Balm?: This book just arrived in the mail for me today and I can't wait to read it!  It is from one of my favorite blogs The Beauty Brains.  The blog is dedicated to explaining the science and debunking the myths about beauty products and makeup.  It has helped me save a lot of money by avoiding loads of beauty gimmicks.  The blog has also taught me to think more critically about the products and chemicals I use on my face, hair, and that I choose to put on my largest organ, my skin.

Philosophy Microdelivery Purifying Peel: This is my once a week, brighten my skin, go-to face mask.  It combines Vitamin C and salicylic acid to promote cell turnover and leaves my skin ski-slope smooth and soft.  I have recommended this to all my friends and relatives.  Go to Sephora or Nordstrom for a sample.  I think you will return to purchase.

Bare Escentuals Makeup:I think mineral makeup is a brilliant choice for travelers.  Also it is fun to apply and provides great coverage.  

Seanik Solid Shampoo by LUSH: My color-treated hair is super fine and I sport a travel-smart bob cut but it has been dry and tired so I just switched to a new shampoo.  I realize I am a little late to the bandwagon but about three weeks ago I discovered solid shampoos.  The lather is out of this world, conditioner is optional, and it leaves my hair squeaky clean with great shine and touchable softness.  The sea salt helps with lift and the seaweed helps prevent dryness.  Buy two and you get a free tin.  I also like Karma Komba but it strips my hair too much for everyday use.  You can overuse this product so just wet it, two to three quick strokes across the scalp and then massage in.  Applying too much will make the hair gunky and leave it weighty with product.

Aveda Pure Abundance Hair Potion: I probably love this the most because of the novel application; it is just so fun to use.  You hold it at seven o clock, 4 inches form you head, and just apply a poof to the roots.  A powder mist of acacia gum turns into a creamy lotion that coats and separates the follicle to create tremendous lift. Imagine hair that has just had a day at the beach and great volume.

Cricket Professional Friction Free 1.5" Brush: I love this round brush with the ergonomic handle and tourmaline barrel.  I can blow dry my hair and set with prevision and ease.  It does not snag or rip my hair and it is less than twelve bucks. 

For more bounce these little travel hot rollers are great.
They heat up in just a few minutes and tuck easily into your suitcase.

CeraVe Moisturizing Cream: This pot of lotion creates a moisture barrier and has hylauronic acid which is important for cell turnover.  It has no artificial color and no fragrance.  It is perfect for sensitive or dry skin for daily use.  After application it isn't tacky or greasy.  

Sonicare toothbrush: I had a coupon to pick this up at Costco and I love it.  The timer keeps me honest so I don't cut any corners in my brushing and that keeps my dentist happy.  This model has a special whitening mode, a travel case, a travel charger, and a UV cleaning system to sanitize the bristles.  The toothbrush stays charged for over a week. I'm a very satisfied customer and recommend this product often to my friends.

So, I am currently looking for an under-eye moisturizer and a makeup remover. I'm also open to other great product suggestions so feel free to comment or email me your faves. I'll return to CRA topics next post. Please forgive my vanity excursion. ;)

Efficiency Tips: Keep the Inbox and Sent Box Empty....and Archive Emails Weekly

This is my Outlook folder list. I try to 

keep the inbox at less than 20 items at 

all times.

Today is Wednesday. I have received/sent and processed over 300 emails. Other Clinical Operations people in my immediate working group see even more traffic in their inbox but I can conservatively say that around 120 emails per day is my typical average. A few folks in my department file nothing and just rely on the blackberry and Outlook search functions to run their email empire. However, I feel pretty panicky if my inbox goes over about 20 messages or so. I use my inbox as my tasklist and I rely on folders and flags to keep everything organized. I've developed a system over the years to keep my inbox slim and zen-like and today I'm going to describe it to you. I also try to review and file items in my Sent box at the conclusion of every day because I prefer to file email responses with the original thread and keep my Sent box empty (Outlook can do this automatically for any message sent from any folder rather than the inbox.  In Tools->Options->Advanced Email Options-> you can select "Save replies with original message").

The batch process approach to filing TMF correspondence
Most site managers I know wait until they are preparing to close out an investigative study site then they go back and read several years worth of emails, print out the ones they think should be filed (2 copies, one for the TMF and one for the site), carry the big bound stack with them to the site, and slip it in to complete the correspondence file. An issue with this approach is that it wastes a ton of time and paper plus you are almost assured to introduce duplicates since the coordinator has likely done something similar. Finally, you are assuming that A) you have time for this exercise at the end of the trial and B) that you will still be around/employed to execute this action. Sorry to be such a realist, but both A and B are not exactly solid suppositions. My approach is to file my emails weekly in the eTMF.  As a result, at the end of every week, I am confident that 90% of my TMF correspondence is filed. I am never more than two weeks behind.

Keeping the inbox empty (or nearly empty...)
I strive to process every email within an hour of receipt. When something hits my inbox I 1) delete it 2) respond to it quickly (and delete it or archive it) or 3) file it. Deleting an email straight away will save you time from re-reading it again; dump it! If the email doesn’t require action from me and I am not waiting on a response, I can just file that email or delete it. I have a folder for my manager/HR/corporate stuff and travel. I have a folder called Praise where I keep thank you notes and email records of major deliverables or accomplishments (this is useful at review time or when I need a pick me up after a defeating day/week). I have a folder for each study I work on. I have a folder for all sites in a study. I have a few folders to keep vendor communications. I have a folder called #Pending (the pound makes it sort to the top of my folder list) for anything with action indicated from me and that takes more than 2-3 minutes to address. I have a folder called #Waiting for things other people are tasked with but that I want to track or follow-up on. I have a folder called #File for items that may be candidates for the TMF correspondence section (no, I don’t file every email in the TMF).

You actually have to Process #Pending #Waiting #File & Sent
I deal with everything in #Pending (at least the items flagged Overdue, Today, and Tomorrow) in the mornings when I arrive at work and in the afternoon when I am wrapping up for the day.

I use flags (Today, Tomorrow, This Week, Next Week) and group by flag to keep #Pending manageable.

At the end of every day (or when I have a few minutes during the day) I go to my Sent folder and I group by conversation trail or category, delete most of the thread, and move the final message to #Pending, #Waiting, #File or one of my folders. Archived in a folder = no action indicated; never to be referenced again except possibly in a future search.

I go through #Waiting at least once a week. When something in #Waiting is addressed by an incoming email message I delete the item from #Waiting or archive it in a folder.

I process #File on Fridays or anytime the folder shows that it contains more than 50 items. I group it by category or stack it by subject line or conversation. I delete everything leading up to the final thread. I typically have about 15-20 actual emails to file each week and I copy those to our TMF. I can just drag and drop from Outlook into our Clinical Trial Management System.

Outlook Features Help Me Stay Organized
I use Outlook quick steps and rules to quickly file things and/or label/categorize (if an email goes to a certain person or has a certain site name referenced in the subject then it gets a label/category automagically for that site). I use Categorize extensively (newsletter, meeting minutes, issue, login credentials, one for every PI name, specific vendor, TMF, reference, reference doc, expense report, personal). I also use search folders, too (mail received this week, mail received this month, with attachments, logins, newsletter ideas, reference, reference docs, amendment items, mail to/from specific people).

Correspondence Reconciled. Easy.
Now that you are so organized, you can actually use correspondence to prepare for your visits and write your monitoring reports. A few days before every visit, I go to the Clinical Trial Management System eTMF, select all the correspondence since my previous monitoring visit and print it to one big PDF. I open that document when I am at the site and thumb through the correspondence that has been filed by the coordinator since my last visit (the coordinator always files new stuff in front of a colored piece of paper). If the coordinator has already filed the item I delete the page from my PDF. When I am all done I email the PDF to the coordinator (remember, the only pages left are the ones the coordinator did not have filed) and ask them to print it and we file it before I leave the site.

Conclusion
I know this all sounds really intense but the system works for me and I have inspired several colleagues to adopt the system (at least in part). Try a #Pending #Waiting of #File folder. You might find that you have a useable and less intimidating inbox moving forward. Be warned however, the whole system falls apart though if you aren’t disciplined about reviewing your new #Pending #Waiting #File and Sent boxes at regular intervals. Please share any email efficiency tips or tricks that you find helpful.

Lead CRA Q&A: Sponsor Furnished Source Documents

Anonymous commented in... "Perfect Clinical Trial Source Documents":
Hi, some sponsors don't allow investigators to use source data worksheets/templates arguing that source data should not contain instructions nor any other items (logo, etc.) which would not usually appear on a patient medical file.  Is there any legislation which confirms this audit finding? -April 7, 2011 3:18 AM 


NadiaBoBadia responds...

Every required piece of
data isn't already
in the medical file?

It would be great if the medical file captured everything we needed for every trial.  However, the reality is that sometimes source documents are required to capture supplemental information or observations that are above and beyond what would customarily be collected in the course of standard of care medical practice. For example, a patient Quality of Life survey, dosing and administration information, or PK lab draws.

Honestly the hesitation to provide source docs with logos might be more of an intellectual property thing rather than a regulatory thing. I know when I worked at CROs we were very careful not to include sponsor branding or logos on the outside of binders or in papers that were in view. We opted instead to reference by study nickname or protocol number. When I monitor, if I see source documents for another sponsor (maybe a competitor) I can discover confidential information and learn about another drug development program; that is extremely proprietary. Many public and private companies have to defend their product rights in patent legislation so it is important to eliminate logos and branding just to protect property rights.

Let's assume however, that these confidentiality concerns are not the reason sponsors don't allow source docs to have instructions, other items, or logos. I have worked for many sponsors that are careful to limit instructions given outside of the protocol to sites. That actually includes CRF completion guidelines, worksheets, and source documents. As sponsors, we have an obligation to produce a protocol that is clear and has scientific merit while protecting subject rights and safety. Some other reponsibiltiies include choosing qualified investigators, providing adequate monitoring, etc. but the regulations in no way require us to provide source documents. This is a gray area and some sponsors feel strongly that they should avoid actions not explicitily delegated as a sponsor responsibility because that introduces risk. Some sponsors do not want to provide source documents at all, let alone source documents with their logos and emblems dotted throughout.

Allow me clarify with an example. If I generate source documents with blanks provided for all of the assessments required at a study visit but I leave one off (or worse, I include extra assessments) then that is in a way instructing the site personnel to deviate from the approved protocol. This is a huge no no because any changes to the protocol should be handled in an approved protocol amendment that is reviewed by an independent IRB. In operations, we face these issues all the time where we want to give sites instructions or clarifications that are outside of the protocol. If the instructions affect patient safety or the integrity of the trial we should always amend the protocol.

So to recap, I'm not aware of any regulations that prohibit sponsors from providing source templates or even including their logos on source documents.  I am aware that some sponsors prefer not to provide source documents or to have their logos on the source for either confidentiality reasons or risk-mitigation reasons. To clarify further, sometimes we provide source documents because we are capturing something for a trial that would not otherwise be captured in the regular medical file. Hopefully that addresses your question. Otherwise, to further research the topic, I can refer you to ICH GCP E6 sections 1.51 and 1.52. Although "source documents" are not explicitly discussed in the regulations, FDA's CFR 312.62(b) you can read more in the relevant section "case histories".

Reader questions may have been edited for spelling or grammar, for reasons of anonymity, truncated, or edited in other ways although the main content remains unchanged.



You may also like...from The Lead CRA archives:

• Investigational Product Accountability June 2010
• Perfect Source Documents January 2011
• Correspondence March 2011
• Routine Monitoring Visits March 2008

On the Road Again

Remarkably, I've only taken three work trips so far this year.  Luckily, I have been doing transcons so my mileage balances and quest for elite status aren't suffering too terribly (12 segments and 17,000 qualifying miles in 2011).  That said, I haven't had a lot of travel stuff to report lately but here is a summary of this week's travel highlights.


Read a Great Book...maybe not suggested in-flight reading
I've read all of Atul Gawande's books and generally I enjoy reading non-fiction, memoirs, or other books/essays that can be digested in snippets since I don't get a lot of focused un-interrupted reading time.  His latest book (that I am finally getting around to reading), "The Checklist Manifesto" was no exception and I was easily able to tear through it on the flight from SFO->IAD (San Francisco to Washington Dulles).  A lot of the book tells stories of avoidable aviation disasters and the response to those issues in flight so be advised that maybe it is a little too chilling to read while actually on an airplane.  I thought it was really well-developed, interesting, and it still has me thinking about how I can apply some of the concepts to my daily work.

I am not a surgeon or a pilot so my work isn't exactly life or death and I really do have time to ponder through problems and work out the right solutions.  However, just because I have that luxury of taking my time, should I really waste the time when I could free myself up for other more interesting assignments or simply produce more?  I just want to get things done. Right. The first time.  So using a checklist isn't about writing down a procedure from nuts to bolts.  It is about identifying what the critical or gating points are of any process and making sure those are done correctly and in the right sequence so that downstream errors are avoided.

Some of the common problem areas we experience in clinical operations are sites that are not recruiting enough subjects, delays in study timelines or deliverables, and failure to communicate critical study information in a timely fashion.  I'm still thinking of others.  I really liked this book and I do recommend it.  I hope to develop a related blog series at some point after I have let the concepts percolate a little longer.


TSA Full-Body Massage
It may surprise many of you that I have all but avoided the new backscatter scanners since they were implemented last year.  I've just been careful about choosing the right security line, booking the right airlines, and avoiding the wrong airports.  Also, I've been lucky.  However, yesterday in Ft. Lauderdale, Florida I had my first opt-out.  The agent motioned me to the machine and I said, "No, thank you."  She explained that she would perform a secondary screening and asked me to go sit in a chair in a glass box off to the side of security.

I opt-out because these machines have not been independently tested for safety and only my husband gets to see me naked.

Did I mention my flight was boarding in 10 minutes?  Luckily I could see the gate from security and I knew I had an upgraded boarding pass waiting for me so I wasn't too worried.  Another TSA agent gathered all my belongings and followed me to the glass box.  He placed my items in bins outside the box and motioned for me to keep them in my line of sight.

The female agent came over and explained the pat-down procedure.  She told me what areas of my body she would touch and when she would use the back of her hands.  She then asked if I would like a private room but I declined and allowed the security theater to continue.  I confirmed that she was using clean gloves.  She reached inside my collar, inside my waist line, and touched all of my private areas (I was wearing thin/slim black pants with no pockets -- mental note, do not wear skirts to the airport). The whole thing took about three minutes,was generally uncomfortable, and I didn't even get a kiss.   It was handled very professionally but I hope to dodge it in the future.  Thank goodness for the upgrade to first; I really wanted a free cocktail and a bath in Purell sanitizer after the TSA rub-down.


Southwest Emergency Landing
At least I wasn't flying Southwest.  Over 300 flights are cancelled today and they have grounded part of their fleet to review the integrity of almost 80 aircraft following a "mechanical failure" where the skin of an airplane ruptured following ascent over Phoenix and caused a hole in the fusealage, rapid de-pressurization, release of oxygen masks, and an emergency landing.

Here's to hoping that I will be booking more work trips soon on my carrier of choice, avoiding the TSA circus-act, and that none of my future travel will be on Southwest.