5 Mistakes to Avoid as a Clinical Trials Monitor
Mar 9, 2015 (Posted on LinkedIn) by Dr. Vera M. Madzarevic
You must have gone through the daily drill of preparing for the monitoring visit countess times. However, you never prepare for unexpected situations that may greatly impact on your performance and the perception of your skills to handle a very stressful situation. Being responsible of a team of monitors and managers, exposed me to countless of situations that can go very wrong unless you are prepared to face them effectively.
With these examples, I intend to assist positively field based clinical trial monitors. The process of formulating the mistake, the consequences and the possible solutions aims at providing a structured approach for easy reading and comprehension.
This post focuses on 5 serious mistakes that every monitor should avoid to be able to remain compliant and in good terms with all parties. These are based on years of experience in the matter dealing with issues, sometimes, in uncharted territory.
Mistake #1 – While on monitoring visit, spending your time on the phone dealing with other site issues .
You are very much aware that your visit has been planned very much ahead of time and budgeted by the sponsor and is expected that you dedicate your time at the site working on your site visit. If you are providing services for a CRO, you may be involved on studies for many different sponsors, and dedicating time assigned for one on behalf of solving issues for another will only impact on your performance, where oversights may happen.
That may result on:
- your inability to complete the job in the assigned visit,
- need to reschedule an extra unplanned visit,
- cost overruns
- possible oversight of serious issues due to the lack of time, and
- potential non compliance
The solution:
- check the call display to verify the caller,
- return the call in an assigned time (e.g. breaks assigned purposely to admin jobs during visits) and,
- make sure that you read all the messages (text and voice) before you respond to a particular call. You may be surprised how many times the coordinator who placed the original call may call again to tell you to “never mind”.
Mistake #2 – Write serious observations in the monitoring report without previously discussing the matter or preempting your intentions to the principal investigator
It is not uncommon that you may perceive something as a serious issue at a clinical trial site. That may be sometimes your own perception, and with more communication with the coordinator and involving the investigator, you will have a better insight on the concern. For example, source documents are not available for you to verify. Those documents may be filed elsewhere due to the document management system at the facility, however they were not provided to you at the visit. Guiding the site personnel on what do you need instead of just flagging it and reporting it as non-compliance to the sponsor, will allow to clear the matter in a moment time without hard feelings.
That may result on:
- This mistake can cost you the much needed good relationship with the site personnel. However if the issue reoccurs, you may have to change your strategy and recommend more training to the site personnel.
The solution:
- Always try to solve issues amicably.
- Open ways of communications with the site.
- Make sure that the site is aware of your observations
Mistake #3 – Take things in your own hands
It is sometimes very frustrating to see that a site makes the same mistakes again and again and that you are pointing out the same things every visit. So, to avoid again the same talk with your coordinator or investigator, you do the job for them. This is a very dangerous precedent, since the coordinator will expect in the future that you keep doing it. Your job should be pointing out at concerns, verifying data and that patients are safe, making sure that the site adheres to the protocol and compiles to regulatory requirements. Your job is not to do things for the site to avoid non-compliance issues. It wastes your time, and puts a lot of stress on you. If the site does not have enough personnel to do the job, make sure to stress that in the monitoring report as well as the delays that lack of resources is producing.
That may result on:
- Burn out
- Cost overruns
- Oversights
- Reduced performance
The solution:
- Make sure that the site has been properly trained
- Make sure that the investigator has real time available to do the expected job
- Suggest methods to save time and be more effective
- Be of assistance, but do not take things in your own hands.
Mistake #4 – Confronting your Principal Investigator/coordinator with suspicion of fraud or misconduct
Eventually, you may be faced with challenges like this one in your career, and is not an easy one. If you suspect fraud or misconduct at a site, NEVER confront the site personnel or the principal investigator. First, make sure that you are aware of your company procedures on how to deal with fraud and misconduct. Also, collect as much evidence you can (photocopy documents, gather opinions form site personnel regarding issues or inconsistencies, ask site personnel for their own concerns), and document everything. Fraud and misconduct are very serious and should never be handled unprepared.
That may result on:
- Serious confrontations
- Unfounded accusations based on your perception
- The investigator assuming a defensive position
The solution
- Your suspicion of fraud or misconduct may not always be founded, it may happen that the site is just sloppy and disorganized. Focus on collecting information.
- Follow your company procedures for that matters, and inform your superiors
- Keep cool, and do not engage in discussions at the site
Mistake #5 – Sharing work space with another monitor from another company
Although a no brainier, it does happen. It is understandable that you are willing to accommodate you investigators time and space, however sharing space with another monitor is not something you should compromise for.
Make sure that your site understands that you are dealing with confidential information and that you are not supposed to handle confidential material (source documents, protocols, patient’s lists or data) in the presence of not authorized personnel.
The same applies when you are not there, you expect that the site keeps all the documentation pertaining your study confidential.
This mistake may result on:
- Disclosure of patients personal and confidential information to unauthorized persons
- Access to confidential industrial information to the competition
- Inability of doing your job because of the above
- Reduced performance
- Non-compliance
The solution:
- Announce your visit in advance and clearly state your requirements from day 1
- If you are confronted with the challenge on the spot, if space cannot be provided, reschedule your visit
- Provide for training to your site regarding confidentiality of clinical trial records
All these mistakes are not uncommon, and are the source of many issues regarding your ability to conduct effective site visits.