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Dementia and Your Loved One
Six Things That Should Be Done Before A Scheduled Clinical Monitoring Appointment
Vickie Armstrong
Periodic appointments for clinical monitoring are an essential part of working with a clinical monitoring service provider. You'll get the most out of these appointments if you prepare adequately at your research sites. As such, the following are six things that should be done to prepare for a scheduled clinical monitoring appointment.
List any inclusion or exclusion questions from all investigative sites
One key function of a clinical research organization (CRO) when it comes to clinical monitoring is answering inclusion or exclusion questions. It's therefore important to compile any relevant questions from all investigative sites involved in your project before a clinical monitoring meeting.
Review data and data entry submissions
Submitting all relevant data that has been entered to your CRO or sponsor is an important preparation task to take care of. Doing so allows your clinical monitor to review relevant data beforehand to prepare for the meeting on the CRO end.
If you don't handle data submission before meetings, your monitor will have to spend time during the meeting waiting for data to be submitted. This will detract from the productivity of your meetings.
Make sure all necessary correspondence has been filed
Keeping up with correspondence between meetings is important. You need to be submitting inquiries to your CRO promptly when necessary and responding to inquiries you receive from your CRO right away. Communication is key when you're working with a CRO for clinical monitoring purposes.
Look over the action items from previous clinical monitoring appointment
At every meeting, your clinical monitor should list any action items that you need to take care of. If there are still open action items from your last meeting, you should take care of them before meeting with your CRO again.
Review regulatory items
It's a good idea to have a look at the regulatory binder and see if you need to take care of any regulatory items. Doing so before your meeting can make an upcoming clinical monitoring meeting more productive.
When you take care of regulatory items before meetings, you won't have as many missing or expired articles that need to be corrected before research can progress.
Verify the appointment time and site
You may want to contact your CRO before your meeting and verify the meeting time and place. This is especially true if has been an especially long time since your last meeting and you haven't been in touch with your CRO in a while.
Verifying meeting details prevents any misunderstandings and ensures that your meeting can take place as planned.
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