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Tuesday, August 19, 2008

Monitoring Visit: What to Pack

I came across a nice online article recently by Greig Waddell with tips on how to save time when traveling for business. Click here to check out the full article. I thought all of his points were great but I wanted to expand upon it a bit in the context of traveling to a monitoring visit.

So you are going on a monitoring visit. You want to dress sharp and have all the supplies you need. Choose clothes that you can mix and match, that you don't have to dryclean or iron, and that are professional and appropriate. I travel 2-4 days each week so I pretty much just keep my suitcase packed all the time and just replenish/rotate things out for cleaning as needed. This means two sets of toiletries, those I use at home, and those that always stay packed in my 3-1-1 TSA approved baggie. Staying "packed" has saved me on several early mornings when I haven't exactly given myself quite enough time to get up, get out of the house, and get to the airport. Here is a selection of my luggage:

No, I don't travel with 3 bags. Click here and then scroll over the photo at my Flickr site to learn more about what type of luggage I use for different length trips.
I don't check bags with the airlines, but if you do, don't check valuables like expensive jewelry or your laptop. Don't forget that sponsor proprietary information including protocols and regulatory documents are extremely valuable. If you can't carry all your documents, FedEx them to yourself, but NEVER check them because luggage can get lost.

I try to carry as little paper as possible - if the sponsor doesn't provide you with a pocket sized spiral-bound protocol book, Kinkos or a similar copy center will make you one for less than $50 and you'll be glad to have it plus you can probably get reimbursed for it on your expense report (check with your lead first). Remember that you may need to retrieve copies of documents at the site so bring some kind of inflexible folder so they won't get damaged or bent in transport. Other documents I like to bring electronically or carry with me (good to review on the airplane) include the MV Checklist, study contact list, print-outs from the IVRS, and old monitoring visit reports/pending action item lists. So you can follow the links below to find out more about what is in my bag:

More details and photo notes available at my Flickr page.
Click here for a copy of a printable checklist that helps me pack for monitoring trip. It is in MS Word so you can download it and edit to your specifications. Send me an email if you have any trouble downloading the document and I will forward you a copy.

Please also check out my travel tips section for more info.

Sunday, August 3, 2008

Efficiency Tips: Spend less time on Expense Reports

I pay for most things with my American Express (Amex) but I am required to submit receipts for all charges over $10. We either scan our receipts in and attach them through the web browser to a pending report or we fax them to a dedicated fax # with a spiffy system-generated coversheet that accomplishes the same thing. In the expense system website, every few days, charges from the Amex are automatically available for me to add details to (which sponsor is the charge billable to? is any part of the charge non-billable?) and to group into pending expense reports. Unfortunately cash purchases or those made on my personal credit card have to be manually entered and categorized so I try to limit these types of transactions.

I make my own travel arrangements through our travel agency and they pass those charges through to my Amex. Airline tickets, rental cars, and hotels are the bulk of my expenses and whether or not they are reimbursable is very clearly delineated in our travel policy (for example, a $500/nt stay with spa treatment at the Ritz is not OK, but $150 at the Marriott with free breakfast is very much within policy). There are also clear guidelines for our meal expenses and tips in the travel policy too, but in my experience, this is the area where I most frequently have issues with reimbursement. Part of the problem is that I may lose a receipt or they haven't scanned in clearly so my entire expense report can get denied or otherwise held up in processing. For that reason, I typically submit 2 expense reports for every trip. If I have booked airfare more than 2 weeks in advance, that goes through in its own report so I can go ahead and have the company pay my Amex down before 30 days pass. Everything else I pass through up to 4 weeks after the trip in a second expense report.

While traveling and at the time of purchase, I usually slip charge receipts in the billfold portion of my wallet but after a few days the wallet is overstuffed and won't fold closed. A solution I have come up with is to periodically group and file the receipts in a specific pocket of my laptop bag. The keycard folios they give you at the hotel are terrific for organizing receipts so I simply group them together in chronological order in those handy little keycard envelopes. I organize in two categories, transportation related (receipts for gas, rental car, parking, cabs, valet, tolls, etc.) and for meal expenses and tips.

Efficiency: Eating breakfast and working on expense reports.
When I am flying home from my visit, I put down my tray table and prepare all the receipts for scanning. I now travel with blank paper and tape (tape dispensers are bulky so I have taken to carrying self-dispensing double sided sticky crafting squares. I get mine from the dollar store but click here for a link to the product I am using). I fashion all the receipts on as many pages as I need and when I get home it only takes a few minutes to scan the whole stack and attach them to my expense report. Many hotels offer free business centers with scanning and faxing so I could also do this on the road but I like to do it when I get home for now.

Timesheets are due every two weeks so I ensure that when I am signing off on my timesheet I am also submitting any pending expense reports. Our Amex is paid bi-monthly so this helps me to always be current and never go in arrears on my corporate account. You certainly don't look very professional if you aren't paying your credit card on time so I manage this closely. Not to mention, who can afford all the crazy fees they would love to charge you?

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

Efficiency Tips: Spend less time on your Timesheet

I am employed by a service company and we bill our clients for our services. Therefore, we must track our time spent on sponsor related work and pass the costs through appropriately. I am asked to track my time in 15 minute increments so I can basically report up to 4 time categories per hour or I can bill a half or whole hour to a specific time code. In order to receive a good performance rating, I must report at least 85% of my 40 hr work week as "billable time".

My non-billable time codes are things like: Sick, Holiday, General and Administrative Duties (G&A), Internal training (not project specific), goofing off (ok, so that is not a category but if ever I am shy of 40 hrs and can't account for the time then G&A is a good catch all), etc.

Billable time is coded by project (since I might work for several sponsors/projects at once) and then broken down into time categories as follows:
Project Specific Training / Sponsor Teleconferences - Reading protocols, watching power points, reviewing the Monitoring Plan, etc.
Preparing and Following Up - This category is used for making travel arrangements or writing confirmation/follow-up letters, or working on reports.
Traveling - Usually your project will have limits to how much travel time you are allowed to pass through. At my company, when long trips are unavoidable, you can lower your travel time by using the time in transit to complete other project related work such as studying or writing reports (billable to either of the 2 categories listed above) - obviously this works when on an airplane or delayed and not necessarily when driving!
Managing Sites - This is phone or email contacts to your study sites or running special project specific reports.
Conducting a Monitoring Visit - Actual time spent on site during SIV, COV, or routine MV.
Query/Database Management - Helping the site solve/close queries raised by data management, reviewing the clinical database, running reports, etc.
Expense Reporting - see my next post!

OK, so now that I explained how I categorize time, let me explain the time tracking system. You can think of it as a glorified version of Excel that lives on a web server. So to enter my time, I have to log into that system and enter all of my hours. We are asked to do this at the end of every day so we are as accurate as possible. Well, I don't have internet access all the time so sometimes I let a few days pass and it really is hard to remember what you did for the past 48-72 hours by 15 minute increments. To solve this conundrum, I made a copy of the fancy web-based timesheet template in Excel and I just leave it on my desktop. Each day before I log out of work, I update my time in my Excel template. Then every 2 weeks (or as I have time) I log into the web-based system and transfer it all. I know this is multiple steps but it seems to work better for me. You could also use a journal or jot notes about how you spent your time in your day planner. Any other tips?

Efficiency Tips: Spend less time on Monitoring Visit Reports

As a monitor, you may visit several different study sites in a single week and possibly for different protocols. I often find when I get home from a trip like that it is hard to write my report and keep the details of the different sites straight. One thing I have done to successfully overcome that is to draft my report before I even do the visit. On most studies, your Lead will provide you with a template report that you will need to complete following each visit type. You might also use an electronic system to create your reports but luckily, mine are usually just MS Word templates. Every report is guaranteed to have a header section that includes the MD name, facility name and address, visit type, visit date, date of last visit, and list of attendees. You probably know all of this information before you step foot on the site so just fill it in before you go.

Things I am unsure about I highlight in yellow so I remember to return to them later. Unless this is your first visit to the site, chances are there is a previous report completed by either you or another CRA that has items that probably need to be carried over to your current report. You will want to refer to your company's SOPs and your project-specific monitoring plan to know which items get carried forward. On some of my recent reports, this has included Enrollment data (I can usually get the current number of Screened, Screen Failed, Enrolled, Early Term, and Completed subjects from the IVRS system before I even show up for the visit), summaries of Protocol Deviations to date (they stay on the report until the IRB acknowledges receipt of the deviation), SAEs that are not resolved, Regulatory Documents that need to be collected, and pending Action Items or those that have been resolved since the last report date.

Drafting your report before the visit has the added benefit of helping you write your confirmation letter and get a grasp on what activities need to take place during the visit. You will be organized before you get there and more likely to monitor efficiently if you know exactly what is outstanding.

While you are at the site, avoid keeping notes on notebook paper; just write pending items directly into the Action Items or other applicable section of your report. If the items you notes are resolved by the time you leave you may decide to dump them from your report (depending on how much detail your company/sponsor is looking for) and if not, mark them pending and submit them as part of your draft.

When I am at the airport waiting for my flight to board, I can usually knock off a draft report in about 20-30 minutes. Then when I have internet access, I just submit it and forget it (or at least until I get a revisions request)! What efficiency tips work for you?

Not getting any work done in the airport terminal?
Your company may reimburse you for airport lounge
access or you can typically get a discount pass through
loyalty to an airline or credit card offers.  In the lounge
you can be productive, enjoy snacks and beverages,
access the internet and a business center plus plug
in all of your devices.  

Efficiency Tips: General and Administrative Duties

I work at a CRO so we have a fairly robust on-line expense reporting system and a thorough web-based system for reporting our billable and non-billable time through an interactive on-line timesheet. Well, I don't have the new iPhone and we still can't access the internet while in-flight so I am not exactly on-line all the time. The result of this is that I have a tendency to get behind in both my expense reports and time reporting.

Complete administrative tasks
while on the road by booking
hotels that have well-appointed
business centers. Internet access,
printing, copying, faxing, scanning,
and a FedEx drop are a major help.
Timely reporting of billable hours and submission of accurate expense reports are two of the main conditions of my employment. My other big responsibilities are showing up when and where I am supposed to for site visits/teleconferences (that includes making travel arrangements far enough in advance that I am getting the best fares and being cost-conscious for my company and the study sponsor) and getting my reports done on time. I'm never actually late with reports, timesheets, or expense reports, but at times, I have felt like I was not always as on top of it as I would like to have been.

For each of these job responsibilties I have a few tips that have helped me stay under the radar of the big bosses and consistently make my submissions accurately and on-time. I'm always on the lookout for new methods of reducing my workload and working more efficiently, so feel free to post a comment with other suggestions. This is a big topic and I have a lot to say so I will tackle it in three different posts: MV Reports, Timesheets, and Expense Reports

I hope you find this series helpful!