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Tuesday, June 25, 2013

Do you know a CRA Rockstar, a Super Study Coordinator, or an excellent PM?

Tell Them About the US Clinical Researcher of The Year Competition

The US Clinical Researcher of the Year competition has been accepting nominations since March.  They will continue to accept nominations until September, but why wait?  Nominate someone today who works hard in Clinical Research and deserves to be recognized.  There are separate categories of awards for CRAs, Study Coordinators, Project managers, and Clinical Study Teams.

I participated as a contestant the first year of the competition so I am now happy to promote and endorse the contest this year to all of you.  I made valuable networking connections, felt recognized by my peers, and had a lot of fun.  It was an absolute blast and I even took home a prize! I'm lucky to have great people in my network and each year I have recommended others. In fact, I've had at least one colleague at the competition every year!

Three Steps For Nominees to Complete

Once you nominate someone they receive an invitation to complete a questionnaire and confirm their interest in the competition.  The questionnaire is role-based and evaluates basic functional skills and knowledge of the regulations and guidance's related to their job.

The next stage of the competition is the "Clinical Competency Challenge: This requires candidates to respond in writing in no more than 1,000 words to three category specific competency questions and one further question, which explores the candidate’s reasons for entering the competition."

Finalists for this year's competition will be announced in October.

When I attended the finals, I was given a written challenge exercise where the topic was provided but I had to prepare a short presentation and Q&A session to a panel of judges; my presentation lasted about 20 minutes and I had less than an hour to prepare. All of the judges were pharmaceutical and CRO executives and they were attentive and supportive. I was asked interesting and thought-provoking follow-up questions and I had a lot of fun. Then, I had the rest of the day to meet my industry-peers, explore the area (it was in Philadelphia), and sweat it out in anticipation of the results.

The final phase of the competition and the much-anticipated award ceremony (black-tie/tuxedo) will be held 7 November 2013 at the Executive Briefing Center, SAS Campus, Cary, North Carolina (my hometown - they should invite me to be a judge!).

Nominate Someone Today

Go ahead and use this link to nominate that awesome Study Coordinator you loved working with, CRA rockstars (less than 4 years experience and Senior CRAs), and/or Project Managers.

Do you deserve to win?

Well, why don't you prove it by nominating yourself!  This competition is open to US residents only - good luck!

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Monday, June 24, 2013

Are you at DIA? #DIA2013

This weekend, many clinical research folks headed to Boston for the 49th annual Drug Information Association conference.  Although I didn't make it this year, I'd love to hear from you if you attended; especially if you are a Clinical Research Associate.

Is the conference valuable for CRAs?  Would you like to share some highlights of your experience in a guest post or comment here at The Lead CRA blog?

This weekend I kicked off a new blog series at The Clinical Operations Toolkit blog called "The Buzz" and I listed the posters, sessions, and workshops that caught my interest.  If you do go to the conference and attended any of these, I'd love to hear your impressions and takeaways here or via email.

DIA 2013 - The sessions I regret missing: Part 1, Part 2

Have a fun week at DIA!

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Thursday, June 20, 2013

The Lead CRA Interview with an Independent CRA

The Lead CRA asks: Annmarie, when you show up on site you always have your objectives planned out. What kind of prep work do you complete prior to visiting a clinical site for the first time?

Annmarie: I send a detailed confirmation letter indicating my goals and expectations. So that the site clearly comprehends what will be occur during the visit.  I also generate a site folder that is specific to the site.  Within this folder there is a section for site location/staff contact/lodging.  A section for Regulatory and Pharmacy along with an up to date copy of the Screen/Enrollment Log.  I also include a section for correspondence that I might want readily available and on hand.
Dress like a professional.  You are representing the company and you are a reflection of them...."a pet peeve of mine"!!!!

After the first visit is done, what kind of monitoring visit preparation is required for interim monitoring visits?

I prepare another detailed confirmation letter that clearly specifies the date* and time of arrival to the site and departure, objectives of the visit, and outstanding action items that need to be resolved prior to my departure.
*It is important to reserve enough days during the visit to accomplish all required and planned activities.  I typically confirm all my routine monitoring visit before departing the site at the conclusion of every visit.
 Now that I have met the staff in the previous visit. I put a lot of thought into my "communication techniques" that would work best with the personalities of the site staff in order to successfully accomplish my goals for the visit.
Be are part of a team (or an additional set of eyes) that only wants to ensure that the data is clean and that the subjects are safe. Presenting yourself in this manner will make the site staff want to work with you and for you.

You enjoy a lot of flexibility as an Independent and you make your own work schedule.  What is your favorite thing to do when you are not on the clock?

I love being a wife and mother of 4.  My kids range from 25 down to 13.  We are avid boaters and live on our boat all summer long. What I consider "my time" is yoga, running and when I take long walks with my 150lb Newfoundland dog named "Bella".  For whatever reason she really relaxes me after a long hard day.

Your business is all about referrals and personal connections, any networking advice?

Integrity is the key. Only recommend, work, or refer someone that you hold in high regard because Monitoring is a very small world. The people you affiliate with are a "reflection" of you.
Special thanks to June's first guest CRA blogger, Annmarie Schaden, RN, CCRA.  Annmarie is a talented Senior CRA independent consultant for hire residing in Michigan.  She is a brilliant monitor with special expertise in monitoring early phase, Phase I units, CNS, cardiovascular, HIV, infectious disease, and oncology trials.  Annmarie is a licensed nurse in Michigan with extensive experience in pulmonary/cardiac medical and surgical intensive care, the Emergency Room, and home health care for oncology and pediatrics.  She is a member of DIA, ACRP, and ANAC and she is recommended by The Lead CRA.

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Thursday, June 13, 2013

Risk Assessment in Monitoring

Clinical trial monitoring necessitates timely and accurate risk assessment. Risk assessment has become particularly relevant given that industry pioneers are increasingly and aggressively considering a risk-based monitoring paradigm. This paradigm is endorsed by consortiums like TransCelerate and supported by guidance issued from regulatory agencies such as FDA and EMA. So, how should a CRA assess risk accurately? What should be the balanced approach for site monitoring given that it is a cost intensive exercise with patient safety and quality being at the core of it?

Framing and classifying risk correctly

Acknowledgement of risk in the right context is important prior to its assessment.   Known or fixed risk factors at a program or protocol level should be considered first. At a program level, these risk factors could pertain to organizational dynamics, operational complexity (nature and extent of outsourcing), investigational product class, logistics and supply chain. Protocol level risk factors (such as TA, number of invasive procedures etc.) and site-specific risk factors (such as site experience, historical site performance etc.) should be accounted for, before developing the monitoring plan. Dynamic or unknown risk factors should be looked at using a relevant set of risk indicators to help evaluate the unknown risk elements during the progress of a study.

Using the correct risk indicators

It is important to identify risk indicators that serve as the right trigger to recalibrate monitoring activities. These indicators should be direct or surrogate pointers to   issues and risk that arise during the course of a study. A reasonable set of indicators for tracking site and study performance could be centered around quality, timeliness and efficiency. Timeliness of data entry, query resolution timelines, number of protocol deviations and adverse events; screen failure, early termination and site enrollment rates, are all good candidates for ‘signal detection’. Analytics-driven dashboards that provide trends and benchmarked assessment of these risk indicators for all sites in a study and that help identify outliers across the study performance spectrum are excellent tools to leverage for better risk assessment. Site performance across these indicators should ultimately convey a message that builds trust of regulatory agencies, in the quality of data being captured and reported during a clinical trial.

Leveraging technology to improve risk assessment

Successful adoption of technology, data integration from disparate sources and leveraging analytics optimally is critical for improving monitoring efficiency.  Cohesive technology-based monitoring solutions can assist greatly in early and ongoing risk assessment, by leveraging the real power of EDC systems to focus on critical processes and critical data. These targeted monitoring solutions should link protocol objectives to endpoints to ascertain risk and enable adjustment of monitoring activities in real-time. Leveraging technology-based solutions early on, through a quality by design-based approach during protocol and monitoring plan development, is ideal to mitigate risks at the later stages of a trial. Adoption of EDC systems supports remote and continuous transcriptional verification of clinical data; rather than as a retrospective exercise.  This keeps the quality and costs in control while keeping focus on aspects that “matter more”.

Verifying or reviewing the relevant information

The practice of doing 100% SDV is now being seriously questioned from a need and ROI perspective. Data analytics from the Medidata Clinical Cloud™ - based on thousands of clinical trials across the globe indicates that nearly 97% of clinical data entered for the first time is available for downstream use in its final form. Initiatives such as TransCelerate support that SDV has minimal effect on data quality – only 7.8% of total queries are SDV-generated and a smaller subset (2.4%) of queries are generated for critical data. Monitoring activities should cover both transcriptional verification (Source Document Verification or SDV) and SDR (Source Document Review), the later revolving around investigator involvement, protocol and guideline compliance. SDR is more important from a quality and regulatory approval perspective and therefore technology-enabled offerings which holistically address these aspects of the clinical development spectrum are likely to be more valuable to site monitors and CRAs.

Managing and mitigating Risk

Ongoing assessment of risk based on pre-defined risk indicators, critical processes and data should be the foundation of any monitoring plan. When needed, monitoring activities should be scaled up with the expectation of returning to the standard level in future. This return to baseline should occur post a root cause analysis of issues, thereby mitigating future risk. The approach of recalibrating verification and review activities should be closely aligned with the technological capabilities before the start of a study. It is important for monitors to reinforce expectations around data entry and query resolution timelines and ensure adherence to predefined SOPs and workflows stated in integrated risk management plans. This holistic approach involving data-driven process change and technological enablement, which starts early on with protocol design and site engagement will empower monitors better to perform their duties effectively.

Author information:

Associate Product Manager, Medidata 

Geeks Talk Clinical
Geeks Talk Clinical Medidata Blog

Special Thanks to today's guest contributor, Medidata.  Will you add to the conversation?  I invite you to author your own Lead CRA post. I'm accepting new guest contributors now, send me an email if interested.

Further reading at the ClinOps Toolkit blog:

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Tuesday, June 11, 2013

You are The Lead CRA: Five Years Later and a New Blog Format

Somehow I managed to completely miss my blog a long shot.  I've been the Lead CRA author for over five years and thanks to your collective 250,000+ visits the project has been a personal success and very rewarding.  In October of 2007 I started the blog as a place to catalog my adventures in a new regional CRA role and had a tremendous amount of fun shaping the Lead CRA into my personal brand.  I published once or twice a month, communicated with many of you via comments and email, mentored several new CRAs to help them kickstart their monitoring careers, began speaking at conferences, and made a lot of valuable professional connections.

Where Did the Time Go?

Along the journey I worked at a couple of excellent CROs and I am grateful for that experience and a series of important managers, mentors, and friends that have all helped shape my career.   However, I transitioned from Lead CRA into a Clinical Program Manager role a few years ago. I still interact with monitors and in-house CRAs as part of my role, but I am more rarely on-site where the clinical trials are being performed. When I do travel, I am not monitoring but rather overseeing the operations of many trials within the clinical program.  I have relationships with individuals at study sites but in many cases I actually delegate site relationship building and maintenance to the CRA Site Managers, most of whom I do not directly manage.  As a result of my evolving role in clinical trials management, I'm finding it more challenging to keep the content here current, relevant, and interesting to CRAs.  

What's Next for the Blog?

Actually, I'll be focusing my blogging efforts moving forward on a new project I started last month, the Clinical Operations Toolkit.  I invite you to follow along if you are interested in Clinical Trial Management.

I'll pop in from time to time to author a Lead CRA post here and there.  I'll still stand by for your emails, review and respond to comments, and we can stay connected on The Lead CRA Facebook page.

Do You Have Something to Say? How about writing the next blog post?

So, this was my blog for over five years, but now it is your blog; you are the Lead CRA.

My vision is for this project to evolve so that the bulk of the new content is generated by you and other CRA or industry experts.  You'll start seeing new authors here, beginning this week.

If you'd like to write a post for the Lead CRA blog please contact me via email.  I am available to suggest topics and I will help you as needed to write and edit the content.  Please join the conversation, you are now the Lead CRA.

Thanks again!

I'm looking forward to staying connected!  Thank you for your support, encouragement, and loyal readership over the years.


Wednesday, June 5, 2013

Monitoring Visit Follow-Up Letters

You’ll send a confirmation letter (or email if your SOPs allows it) prior to every monitoring visit, be it a pre-study qualification visit, a site initiation visit, routine monitoring visit, close-out visit, etc.  Then you’ll need to document your visit findings in a monitoring report.  Finally, you will send the principal investigator a follow-up letter summarizing the visit and discussing any critical findings or action items.

Create Your Monitoring Visit Follow-Up Letter

As a rule, I try to keep the follow-up letter to no more than two pages.  It is best practice to have the letter completed, reviewed, and sent within 7 days of the visit.  I write the letter to the Principal Investigator (PI) but Cc in the coordinator and trial TMF and/or the regulatory person, my Lead CRA or Project Manager, etc. as appropriate per my SOP.
your Lead CRA or the Sponsor may want
to approve the letter or provide a study-specific
template so check with your Lead before you send it
I dedicate the first sentence to listing the personnel who were present at the visit and thanking the study staff for their time and attention during the visit.  Be sure to include the dates of the visit as the letter will be filed in the Site Master File and the dates should match the Monitoring Visit sign-in log dates.  This is a good point to discuss any staff changes or recommended re-training.  Next I typically document the progress of study enrollment and then proceed to summarize the status of the Site Master File review, source data verification, and Case Report Form completion.

A Summary, Not a Novel

I break up the content where possible by using in-text tables or bulleted lists to note the following items as appropriate per the trial monitoring plan and SOP:

  • Informed Consent tracking details
  • Summary of patients/Case Report Forms reviewed
  • Site Master File or Source Documentation deficiencies/inconsistencies or Safety Findings
  • Protocol Deviations or Critical Findings (and appropriate recommended corrective actions as discussed with my regulatory contact, PM, or Lead CRA)
  • Supply Issues: lab kits, Investigational Medicinal Product, source documents, etc.
  • Action Items: resolved since last visit, new pending and wherever possible

No Surprises

My most important tip for follow-up letters is, “no surprises”.  During your time on-site you should be meeting with the PI and discussing the status and progress of the visit.  You should be summarizing your findings and discussing any issues so they can assist you to resolve everything while you are on-site.  If there are deviations or safety issues that need to be reported to the IRB, you can remind the Investigator of their responsibility to do so.  You can also provide re-training on the protocol or study procedures during your meeting on-site.
The Follow-Up letter should be
a recap of your discussion, not a news flash

In regards to action items, it is best practice to resolve everything before you leave the site to the extent possible.  I have extended monitoring visits to an additional day with approval from my Lead when there were items I would be able to complete with an extra half a day or so rather than leave pending.

If you are unable to meet with the PI during the visit, document this in your follow up letter and include a reminder that you are available by phone to speak with the PI.

Follow-Up Letter Template

I’m not planning to post a template.  Please don’t email me for a template as you can easily make your own using the guidance from this post that is study-specific for your trial’s needs.

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