As we move into the newly defined world of Risk-Based Quality Management in Clinical Trials (FDA Guidance) a Monitor might think their skills are being tempered and possibly replaced with data reports geared to trigger a site visit because of increased safety events, missed subject visits, low enrollment, etc. Not so – as the number of physical site visits are cut back because efficiency and cost-effectiveness; the Monitor becomes the ever more important link in the study team chain.
The shifting of work from the Monitor to the study site continues at a rapid pace; multiple EDC systems for data entry, CTMS for study management, Central Randomization System (CRS), EHR, central laboratories and Monitor access to EHR via IT (network security), etc.
The study Monitor becomes the go-to person for all of the above and is sometimes the one face to face Sponsor/CRO contact throughout the entire study period. So, let’s get back to the basics:
- Be the point person for the study protocol; if you don’t know the answer find out and relay back to the site; don’t just forward that person’s contact information – you need to know the answer too
- Communications – find out the best method for your coordinator whether it be a second email, a phone call or even texting and when the best times are to call; note down their typical at-the-work desk times
- Work closely together at study startup to understand the work flow process for the department, who does what tasks
- Ask for a tour of the department(s)/units involved, introduce yourself and find out how the patient flows through the hospital/clinic system
- Be aware of the site’s local community events, news, weather, etc., these are good conversation starters and help build relationships
- Find out what the allowable budget is for site treats like doughnuts and coffee, lunch, etc. Be aware that some institutions frown on this so check on the rules
- Come in with a friendly, let’s work together attitude and be patient, not all action items can be dealt with in single visit – life happens so take it in stride
- Don’t be judgmental and overly critical, use common sense and approach as learning experiences; most errors and deviations are innocent but work out a plan to address using CAPA principles
- Be aware of the atmosphere of the department when you visit, again common sense but subtle clues in body language, emotions might help you in adjusting the agenda for a more productive visit
- Volunteer to make copies (again, follow the rules), file all the new documents in the binders, ask what supplies or help they need, and follow-through promptly
- As you review the records jot down or flag items to discuss at the end of the visit as part of the de-briefing time; this is part of the study protocol reinforcement process
- Monitors make mistakes too, be appreciative of your ‘training’ and willingly correct errors
- Finally, be aware of the big picture; you may end up working with these people again so it is important to be a good ambassador for clinical research