CRP 106 Lecture 10 Flashcards
Formal Communication and DocumentationPrior to Study Visit
First step prior to conducting visit is scheduling date and time with investigator and coordinator for a visit
Time Requirements for a Visit:
-Study Coordinator – should have sufficient time throughout the day to be able to assist in addressing observations
-Investigator – time should be devoted to monitor entry (briefing) and exit (debriefing) meetings
-Dates and times for visit should be determined either at previous visit, by email or telephone, when a scheduled visit is required as per Monitoring Plan.
-Once dates and times determined – appointment confirmation letter should be sent.
-Appointment confirmation letter should include:
-Dates and times of visit – including anticipated arrival and departure times
-When meetings with investigator are to occur
-What items will be reviewed during the visit and what documents are to be available
-Few days prior to visit – telephone or email site to confirm conditions still acceptable for visit
-if RBM system has flagged for on-site visit, timeframes may not be as flexible
Formal Communication and DocumentationDuring Study Visit
-Sign the Study Visit Log documenting you attended the site
-As mentioned in previous classes, use checklist/quality system to ensure you have completed all tasks required
-As monitors we can sometimes focus on the details without keeping an eye on the big picture
-Keep on track and don’t forget critical activities by using these tools
-See individual class notes regarding items to review during these visits
Formal Communication and DocumentationAfter a Study Visit - To Sponsor/CRO
-Monitoring visit reports must be submitted to Sponsor/CRO within required timeframes as per SOPs
-Report should include actions taken and summary of findings at site
-If problems identified, action that has been taken or action that needs to be taken to address problem should be documented in this report
-Critical findings observed during visit may need to expeditiously reported to –sponsor/CRO by other methods to ensure immediate and appropriate action taken (i.e.: even before report is finished)
Formal Communication and Documentation Site Follow-up Letters/Monitoring Reports
-monitoring follow-up letters are accessible to Health Canada during inspections (generally maintained in ISF)
-always use appropriate and professional language and are factual
as per GCP:
-The monitor should submit a written report after each monitoring visit
-Reports should include the date, investigative site, name of monitor, name of investigator and any other individual(s) contacted
-Report should contain a summary of what was reviewed and statements concerning significant findings/facts, deviations/deficiencies, conclusions, action taken or to be taken and/or action recommended to secure compliance
Formal Communication and DocumentationAfter a Study Visit – To Investigator/Study Site
-Follow-up letter is provided to site after study visit
-Good practice is to thank the team and investigator for their time and for accommodating the visit
-Letter should include actions that should be taken by the site to address and correct observations
-If certain questions could not be answered by staff during visit, this should be included here for follow-up
- be courteous, professional and factual
Corrective and Preventative Action Plans (CAPAs)
-When a large scale or repeatedly occurring deviation is observed
-When this action affects the safety of research participants (or study staff in device trials) and data integrity
-Corrective action: immediate action to a problem that has already occurred or has been identified
-Preventative Action: action taken to eliminate the root cause of a potential problem
-Root Cause Analysis: using a system or method to identify the root cause(s) of problems identified or events observed
-Quality management approach to problems (stems from GMP and manufacturing realm)
-a CAPA allows for a systematic strategy for addressing GCP compliance issues once identified
Site Relationships
-Maintaining professional relationship with each site is key to ensuring high quality work is conducted
-Building relationships takes time and effort; this starts with your first interaction with the site
-Poor perception of monitor can have long lasting consequences
Perception
-remain vigilant to ensure you are not perceived poorly by investigator, coordinator and their teams
This can be minimized by:
-Being prepared for all site visits
-Being competent and well versed in clinical research methods and conduct
-Ensuring you always maintain your composure and remain professional regardless of the situation faced
Respect
-One of the key factors in building positive relationships is having respect for those you work are working with.
-This includes being respectful of numerous factors including
-Time devoted to the project
-Knowledge they bring to the project
Respect: Time
-Strive to be respectful of time devoted to the project by both investigator and coordinator
-This can be demonstrated in many ways:
-Being punctual – arrive on time or a little early to the site
-Show appreciation for time coordinator spends preparing for the visit
Respect: Knowledge
-Investigators and study coordinators are knowledgeable regarding research area.
-If have items to discuss regarding management of participant according to protocol: Ensure adequate discussion can occur and that team can provide any rationale for actions taken
-Discussion and refinement of a process through mutual understanding and respect is more effective than enforcement
Reinforcement
-Use positive reinforcement when possible
Eg: if coordinator has done a task exceptionally well, consider mentioning this during meeting with investigator
-If negative feedback needs to be given, provide it in a constructive and respectful manner
-Do not assign blame to a particular issue, more likely than not, it’s a systems/process failure that has lead to issue
Communication Strategies
-Be an effective listener
-Be aware of your body language
-Ensure you use an appropriate tone of voice
-Use an appropriate mode of communication for the issue identified
-If significant issue, may chose to have in-person meeting (if possible), telephone or video call as initial form of communication
-Follow-up with email summarizing conversation and follow-up action tasks as documentation of conversation
-When delivering message, take perspective of receiver.
Professionalism
-Dress professionally and appropriately
Be timely in your responses
-Maintain composure at all times
-Be courteous – please and thank you will go a long way
-If you make an error (we all will), take responsibility and take prompt action to rectify it
-Be competent in monitoring techniques, GCP, regulations, protocol, policies and SOPs, etc.
Foster a Team Approach
-Do not get into an “us” vs. “them” mentality
-All members of the team at both site and sponsor play a critical role in study completion
-Work towards a team where monitor and study team complement each other
-Constantly reinforce the fact that both site and sponsor are working towards the same goal of conducting quality research
Handling Observations/Issues Identified
-Understand the issue fully
-Consider and be open to alternative solutions to issue identified
-Develop effective action plans to deal with identified issue – use a CAPA if significant or ongoing issue
-Communicate plan with all affected parties
-Address issues promptly
