Tips for Better Monitoring Visits

These are four tips for great monitoring visits.  It all comes back to developing solid relationships as a site manager so you will have access, cooperation, and enjoy more productivity during your time on site.

1. Effective Communication Between Visits

Maybe your coordinators truly are
time-strapped or maybe they just
need a little cheerleading. 

Great communicators know that strong relationships are built on 2 parts listening/respecting and 1 part actively addressing concerns and providing solutions.   Follow-up with your sites weekly to track enrollment, discuss supplies, answer questions, and track EDC completion.  If things aren't trending consistently with your other sites work to uncover the root cause.  During your calls remind the staff of important study updates, upcoming data deadlines, or recent correspondence.  This is especially important with complex protocols.  Keep the check-ins positive, praise often, and be respectful of your site's time.  Communication is a two-way street and hopefully your sites will be comfortable to reach out to you as well.  If you are providing value to your site, they will be more likely to call you when they have questions or concerns rather than proceeding to make errors in execution that you may not discover until your next visit.

2. Assess Site Skill Level
The worst thing you can do is show up to a site and tell them how to run the study.  Don't discount the experience of the investigator/staff. When you go in like a hall-monitor and immediately criticize their process, they will stop listening, become defensive, and you will not be able to compel them to review or revise. First see and appreciate how they are organized, what source are they using, where are they losing efficiencies, and where could they be more precise.  Your first visit should be more than 75% observation and checking things out and less than 25% training unless they are asking for more.  Remember that you can train after the visit during your follow-up phone contacts.  You will need to tailor your site management approach depending on the experience and comfort level of your site.

3. Prepare for the Visit
From your home office or at least a week in advance of your monitoring visit, read the past report, review that pending action items are resolved, and ensure your study coordinator and other relevant site staff will have adequate time for the visit (if not, consider rescheduling). Know the enrollment rate for this site and other sites in the trial.  Compare the performance of this site with other sites and review all the EDC queries and responses since your last visit.  Communicate the agenda prior to the visit.  If you prepare properly for the visit, you'll reduce the risk of a non-productive visit and also be ready to handle any surprises you might discover on-site.

4. Demonstrate Flexibility
Sure you have an agenda and you can't possibly leave the site for the airport until you've achieved all of your objectives, but be willing to shift your day around to accommodate your busy coordinator.  You can perform your monitoring tasks in a different order if that helps the coordinator get organized and juggle your visit while still attending to other priorities.  Agree to do drug accountability while your coordinator wraps up a few outstanding queries in a patient chart.  Agree to meet with the PI at mid-day since they have clinic visits all morning.  The staff at the site will appreciate your flexibility.


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

• Motivating Your Study Coordinators February 2011
• What is up with this coordinator? November 2010
• Routine Monitoring Visits March 2008

Lead CRA Q&A: Do We Have To Do an SIV?

Melissa commented in... "Pre-Study Visits and Site Initiation Visits":
Do sites HAVE to have an SIV? Especially for a simple data collection study? Or is a web training sufficient for sites that have done research with us before?  -September 9, 2011

NadiaBoBadia responds...

Hi Melissa, it sounds like you may be working on a non-interventional observational study (so no medication or any special assessments or survey instruments are given. For your study, perhaps you are just reviewing standard data that would be collected in the course of normal clinical conduct). In that instance, you may be able to do a web training for sites that you know and have worked with recently.

Without an in-person visit, however, how will you be sure that the facility remains adequate and that the study can be conducted there feasibly? As sponsors, we are obligated to ensure that the people working on our studies are qualified by education and experience. You could do that remotely by reviewing CVs and monitor reports for other studies. I hope this addresses your question. certainly there is a trend to not have expensive Investigator Meetings and I have worked on many studies where the PSV is combined with an SIV.

 It is important to visit a clinical study
site to inspect the labs, pharmacies,
facilities, storage, and other areas
where the research will be conducted
to ensure they are adequate.

It is more rare for me though to work on a study where there is no SIV at all but this sometimes happens when it is a site that we have had recent experience with (say in the past year).  We sometimes also waive the SIV when the PI and the important study staff attend the IM. If you won't be performing SIVs, definitely document at the sponsor level TMF how you determined the sites were qualified and trained.

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:

• Selecting Qualified Investigators April 2010
• Routine Monitoring Visits March 2008
• Close-Out Visits July 2008

ACRP 2012 Global Conference in Houston, TX

I received a mailer the other day with program details for the ACRP 2012 Global Conference.  I am on the ACRP mailing list but I have never attended the conference before.  This year it is being held in TX April 14-17.  There are a handful of sessions I would be interested in and I think the networking and vendor showcase could be worthwhile.  The conference has content for monitors and program managers but also content geared towards study coordinators and site directors.

Here is a link for more information on the conference if any of you are interested in attending:

http://www.acrp2012.org/acrp2012/public/enter.aspx

Who is heading to Texas for ACRP Global
Conference in April?  Blackberry and Brisket...
who could ask for anything more!

If you have been to the conference before I'd love to hear if it was fun and useful.  You can leave a comment here or shoot me an email at leadcra-mail@yahoo.com.

Lead CRA Q&A: Consenting Subjects Before IMP is On-site

Anonymous commented in... "Pre-Study Visits and Site Initiation Visits":
Post SIV, can a site share the Informed Consent Form (ICF) with pre-identified subjects prior to Investigational Medicinal Product (IMP) receipt at the site? -November 26, 2010


NadiaBoBadia responds...

Hi and thanks for your question. In one of my previous trials, all of our sites consented and screened subjects prior to receipt of Investigational Product. First shipment was only triggered after a second qualifying screening visit (4 week screening window with up to 40% screen failure rate).

Investigational Medicinal Product can only
be released to a site once all of the required
regulatory paperwork is in place.

In order to consent, our SOP required that the site be authorized for drug shipment, rather than requiring that drug was actually physically on site. In order to authorize drug shipment the site must have 1) completed the SIV 2) received IRB approval for protocol, ICF, Investigator's Brochure (IB), and all PRO instruments 3) Submitted complete regulatory document package to sponsor (1572, signed/dated w/i 1 year CVs for all personnel on 1572, Financial disclosures, Protocol signature page, IB signature page, etc. (some of this package goes to the FDA before the trial is initiated at the site) 4) fully executed contract and budget 5) written activation letter from sponsor. At that point the sites were allowed to begin distributing ICFs for review and signature.

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:

• Selecting Qualified Investigators April 2010
• Routine Monitoring Visits March 2008
• Close-Out Visits July 2008

The Memo to File or Note to File (NTF) is Overused

These memos are often sloppy, contradictory, confusing, or alarming (I once monitored at a site where the PI had written the following memo “Although employees and family members of Dr. XXXX and this facility were enrolled in the trial XXXX, they were in no way unduly influenced or coerced to participate.” Ummm, wow, this was part of the study record and you can’t retract it under any circumstances).  Memos to File have to be reviewed and reconciled between the Site Master File and the TMF.  Frankly, there are better ways to capture the information i.e. training logs, protocol deviation forms, monitoring reports, etc. so why do many monitors insist that the site generate a million NTF?  I actually ask my coordinators to take it easy on the memos and to avoid writing them unless absolutely necessary or at least after serious consideration.

Some Memos to File are global correspondence from the sponsor or CRO and are necessary to address operational issue or questions (expanded specimen shipping instructions, imaging vendor holiday operation hours, clarification on processes, tracking, substitution of lab kits, etc.) these are beyond the scope of my discussion here.

A Note to File may be well-intended but can also provide an
interested party or inspector with a roadmap to a finding – yikes!

On-site, a series of NTFs all with the same date, in preparation for an inspection, or as a corrective action from an audit are a huge red-flag for me as a monitor.  Just document along the way, during trial operations, and avoid lengthy notes to file.  Personally, when I see file notes, I get a bit suspicious and inspired to dig deeper to make sure I am being given the whole story.  I propose that many NTF raise additional concern rather than actually addressing deficiencies.

Don’t misunderstand, I would propose that a NTF can be a good tool to supplement the clinical conduct record but please try to minimize how often these are used and ensure that they are accurate and contemporaneous.  For example, a NTF can be helpful when you are explaining gaps in documentation or inconsistencies, “B. Hill received rater training on 11-Jan-2011 but the certificate is unavailable, please refer to the training log. “  I would tend to use a Memo to discuss trial-related gaps rather than subject-related documentation issues.  A simple post-dated progress note in the subject’s source can address any ICH/GCP concerns instead.

I’ve used Memos to File to organize Site Master File binders “The pharmacy temperature log for this study is located in Suite 1027 and updated twice daily.  Please refer to the original logs.” and also in the sponsor level TMF to address gaps or clarify, “CRF approvals are filed in section 7.1.2.” “Translation certifications are filed at TMF level 3.6.”

A Memo to File can also be very helpful to reconstruct a record of conduct or to explain corrections that are made to documents that might raise questions.  For example, if an Informed Consent Form had a mistake (the wrong date was written, a signature was not obtained, an incorrect version was used, etc) it may be helpful for the study staff to generate a NTF to explain when the error was realized and what corrective actions were taken to come back into compliance.  If the subject forgot to date then the subject could be asked to date at the next visit and the SC could write a note explaining why a later date was used.  The corrective action could be additional site training and a procedure to review the consent form by a second person at the time of consent; this revision to the procedure would be helpful to capture in a NTF.

I am assuming this will be a controversial topic because monitors tend to be very passionate about whether these notes are a hindrance or a help; please leave a comment with your thoughts.  There is no regulatory requirement to produce Memos to File but I think in some cases sponsors and sites can benefit from them at times…they are, however, more powerful when used in moderation.   Oh, and if you produce a NTF please sign and date it, accurately.



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

• Site Master File: Correspondence March 2011
• Routine Monitoring Visits March 2008
• Close-Out Visits July 2008