Monitoring Tools & Notes

As a regional monitor, I have primarily worked on studies with a conduct period of only a few months.  For these trials, I can typically monitor an entire subject’s source in just a couple of monitoring visits (IMVs).  However, I do use a few monitoring tools to keep me organized and assist with report completion.  I obtained most of these templates and advice from other talented CRAs I've been lucky enough to co-monitor with; special thanks to all my wonderful resources who have been open to sharing tips and tricks along the way.  For studies that last longer than a few months, these tools could be especially handy for resuming monitoring across multiple IMVs.    These are some of my standard and favorite monitor tools:

Generic Calculators & References

Never leave home without a date wheel!

• Height/Weight/temperature conversion
• A date wheel for calculating the # of days between visits (checking for out-of-window deviations)
• Nurse’s Pocket Drug Guide book
• Medical Dictionary
• Websites: webmd.com or drugs.com

Study Specific-Calculators & References

• Visit Window Excel Calculator
• Drug Compliance Excel Calculator (if you aren't an Excel guru then ask your Lead CRA or one of the Data Managers to help you out)
• Pocket-Sized Protocol (If you have a PDF or word version of the protocol any copy shop can produce a little spiral bound or gum-bound booklet for you for around $30-$50....worth every penny and you can probably pass it through an expense report - check with your PM)
• Study-specific CRF Completion Guidelines
• Essential Document Tracker and TMF Submission Form
• Recent Correspondence, Study Newsletters, etc. (nice to have printed on hand so if there is a gap in the Site Master File I can just I can just leave a copy behind at site)
• Blank Study Forms 
• Mocked-Up Study Forms (I have worked on several psychiatric studies that utilized SCID, MINI, or a similar scale/questionnaire to screen for exclusionary criteria.  Since the questionnaires can be so long and involved, having a properly (or prohibited) completed form to compare to the source can be a huge time saver and serve as a checklist. 

Monitoring Report Template and Follow-up letters & Action Item Logs

The most important thing you can bring to every visit is a blank copy of the monitoring report, in my opinion.  Your goal should be to complete as much of the monitoring report as possible while on-site.  If you take your monitoring notes in the report template, you have less paper to keep up with and this will really increase the quality of reports.  The longer you wait to write a report following the visit, the lower the quality -- document your findings while they are fresh.  A monitoring report template also serves as a great checklist to ensure that you don’t forget to do all the routine tasks (like sign the monitoring log, check the temperature records, etc.)

IMV Specific Monitoring Notes & Stickies

If you use a monitoring notes log,
consider producing the log on colored paper or NCR
so it is easier to keep track of in a pile of documents.

Post-it Notes stickies are great for flagging discrepancies and other items that need attention in source documents (blank fields, missing signatures, headers incomplete, etc.) but these can fall off or the coordinator may remove them once complete so that makes going back to verify they have been addressed difficult (I usually flag on the top and ask coordinators to move the sticky to the side to indicate it has been addressed rather than remove it).  I like to number my stickies and/or add little notes to them.  Then I can track the stickies in a subject-specific log like the example here.  

Some CROs and companies discourage the use of formal monitoring notes and stickies (as they can potentially lead to avoidable audit findings if left behind in a source binder) so do check with your Lead CRA to make sure using these types of tools is permitted.  

Don't write things down twice, try carbon paper!

I review my monitoring findings with the Study Coordinator or PI at multiple check-in points during the visit and sometimes they like to take monitoring note sheets with them back to their desk to work on the items while I am there.  If we aren’t able to resolve everything while I am on-site I photocopy the monitoring worksheet so I can write up the action items in my report and review that everything was addressed at my next visit. 

I have also made my monitoring notes on NCR carbon paper before and this has been extremely handy for me in order to leave a copy for the coordinator.  You can have your monitoring note worksheets pre-printed on carbon paper at any copy shop or you can buy the paper yourself to use in your own printer or to fill out by hand.  Also consider just bringing along a perforated carbon paper lab notebook or tablet if you anticipate leaving lots of to-do items behind.

Subject-Specific Monitoring Worksheet 

So again, my goal is always to write as few notes as possible while on-site.  I try to just document everything directly in the monitoring report template, follow-up letter template, and Clinical Trial Management System (CTMS).  That said, it can be useful to have some subject-specific notes when pouring over lots of medical records or extensive source documents.  Your subject-specific monitoring notes worksheet can also be a helpful reference at future visits or when completing authoring a report once you leave the site.  If you develop a little study-specific template, you can easily track out-of-range lab values across visits, ensure that all required protocol tests and procedures were completed, more easily fill out site payment or CTMS trackers, monitor consistently and more efficiently, etc.

Aim to only track things that wouldn't necessarily be recorded in the CRF or monitoring report but could potentially adversely impact subject safety or data integrity.  For example:

•  If lab values are abnormal at a visit, how long do they take to return to normal? Are the AEs recorded properly?
• If AEs are occurring, are new Concomitant Medications being added? Is the dosing of Investigational Product being adjusted?
• Who is completing each assessment (same person each visit?)
• Are all study drug kits being returned at every visit?
• Are there out-of-window visits or other compliance issues?

Base your Excel template on the study Schedule of Assessments

I also try to limit myself to a single page of notes per subject, front and back permitted.  I typically take the notes in Excel so I can copy and paste them into my report but if you prefer to have a printed template, consider the colored paper trick and use something durable like cardstock so you don't inadvertently lose your treasured notes in a paper shuffle.

What's in Your Bag?

So what other tools and templates do you find useful when monitoring?  Leave me a comment here, send me an email, or share your monitoring tips on my Facebook page.  

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

• Tips for Better Monitoring Visits March 2012
• Sponsor Furnished Source Documents  April 2011
• What to Pack for a monitoring Visit August 2008
• Routine Monitoring Visits March 2008

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!

Routine Monitoring Visits

Routine or Interim Monitoring visits are basically any visit that occurs after the site is initiated and up until the site is closed out. As monitors, we visit our sites periodically to ensure that they are compliant with all the regulations, subject safety is being adequately followed, data is being captured in a timely and reliable manner, the Investigational Product is being handled as per protocol and relevant regulations/guidelines, there are no significant deviations from the planned study protocol, all important study documentation is being generated and stored properly, and that the research site is adequately supplied in regards to lab kits and other pertinent study materials. The ultimate purpose of our job is to protect subject safety by monitoring the trial conduct for ICH/GCP compliance.

When planning your monitoring visits
it is helpful to have a reasonable expectation
of how think the medical records and source
documents will be. Know in advance how much
you will need to review so you budget enough
time to successfully complete your objectives.

Your agenda from visit to visit may vary slightly based on the length of the study and how many times you plan to visit, the amount of time you spend to plan at the site for this particular visit, the site's progress to date (if a site has yet to enroll any subjects you surely won't have any CRFs to review or pull), and where you are at with the general monitoring plan (for example, drug accountability may be done all along or just at close-out).

Prior to your visit you will contact the site to set up a suitable time for your visit. Visits typically last a day or two. Ideally, the PI would be available to meet with you during the visit. You will send a confirmation letter to the site once a date is set (be sure to confirm the address before you go if you haven't been there before!). More often than not, your study lead will provide you with a monitoring visit checklist or at the very least, a monitoring report template so you will know exactly what tasks you are expected to perform on-site and what topics to cover. Here are some of the specific tasks that are routinely performed at these visits:

1. Informed Consent Form (ICF) review: You are ensuring that every subject was adequately informed and consented to the study before any study procedures were completed (I recommend checking lab draw times and ECG times - if required at the screening visit - against the consent time to be extra sure that the consent was the first study procedure to occur). There are other state specific regulations you will need to know and monitor for. For example, in some states subjects must be 19 to participate and in California every subject must sign the 'CA Bill of Rights' document, etc. Sometimes there are multiple versions of a consent due to a change in the facility address or the details of the protocol. Ensure that all subjects signed on an IRB approved version (each page will be stamped in the upper right hand corner and the version date will be printed on each page). Proper consenting of subjects is critical to ensure the security and privacy of health data and that subjects are adequately informed of the study procedures, risks and, benefits. If the consent is not signed or properly completed inform the Study Coordinator and do not review this subject's medical chart until consent has been properly obtained.
2. Check for Serious Adverse Events (SAEs): Per the guidelines, an SAE is any untoward event that results in death, prolonged or new hospitalization (longer than 24hrs), significant disability, or congenital anomaly (birth defect). If the event has not been reported, assist the Study Coordinator in doing so and inform the sponsor immediately.
3. Review Protocol Compliance: In your chart and source document review, you can verify that subjects were sign at the right times and the right procedures were conducted as per the protocol. You will have study-specific procedures for reporting deviations. Deviations of a serious nature may be reported in an expedited manner and may need to go to the IRB (dosing errors, unblinding of study treatment, subject enrolled that did not satisfy entry criteria, etc.)
4. Compare source documents to Case Report Forms: You are checking that the data in the chart matches the Case Report Forms (which will be later entered into the clinical database and combined with other subject's data to complete the safety and efficacy analysis for the Investigational Product). Determine whether or not CRFS being completed in a timely manner. You also want to verify that the source is complete, neat (all corrections must be compliant with the regulations - white-out is not OK), attributable (who wrote it? Is it initialed and dated), contemporaneous (was it written at the time the procedure was completed?), valid (is the data collected even possible?), etc. Sometimes you will be asked to pull the case report forms and send them in to data management and other times they will stay at the site until the end of the study.
5. Review Investigational Product (IP): The study protocol will explain how the IP is to be stored, dispensed, and returned. Verify that all of this occurred properly by reviewing temperature logs, storage facilities, administration records, IVRS entries/reports for subject-specific IP accountability, and speaking to the relevant personnel.
6. Regulatory Binder / Essential Documents Review: Determine if any forms need to be updated or pulled for the Trial Master File (TMF). The TMF is meant to be an exact replica of all the documentation at the site. Specific information regarding the contents of the essential documents binder are covered in section 8 of the guidelines.
7. Confirm Site Adequacy / Site Status: Determine if there are new staff at the site or if staff have left. Can the site manage with current staff? Has the site or the lab moved? Confirm that there are adequate study supplies
8. Study-Specific Monitoring Tasks: Depending on the protocol, you may need to perform additional tasks such as shipping materials back to headquarters (for example lab specimens, xrays, etc.), calibrating or reviewing calibrations of equipment, site training, checking eDiary compliance, etc.
9. Review Ongoing or Pending Issues from Previous Visits: At some point during every visit work with the staff to resolve any items identified at previous visits as ongoing issues. Indicate in your report once these are resolved.
10. Review of findings with the site: Whether or not you find issues during your visit, keep the site staff posted on your progress and how things are going. Especially, if the Principal Investigator is not available during the visit, be sure to summarize everything accurately and completely in your follow-up letter.

Try to schedule your next (or next several) visits before you leave the site. After the visit, write your report and send the follow-up letter within a week or per your monitoring plan and refer to your company's SOPs. Always report significant compliance issues to your management, the sponsor, IRB, and QA as appropriate. Remember that you must document everything because of the adage, "if it isn't documented, it didn't happen". Please contact me if I can elaborate on anything or if you think I've left something important out.

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

• Introduction to Monitoring December 2007
• Meeting with the PI August 2011
• Close-Out Visits July 2008