This guidance can be used on an ongoing basis to help you ensure that your study is being delivered to a high standard working with your Clinical Research Associate (CRA). Use this tool as a reference to check that all records for the study are up to date.
Keep your CRA informed of any changes when they happen.
CRAs are a great source of help and advice – contact them with questions. If they can’t help they will have contacts who will be friendly and approachable, give them a full list of Site study contact details.
Work with them to find a compromise for any expectations, you need them as much as they need you.
Get to know who your site CRO/CRA is and who is responsible for what- document this so anyone can easily see this info if needed.
Get clear expectations from your CRO/CRA for the study, how often do they intend to monitor the site, send data queries, study invoicing, etc.
For monitoring visits agree; set time allocation, resources, location (onsite or virtually), equipment & staffing.
Agree that staff will not be with them for the entire visit duration.
Set clear expectation for your CRO/CRA of how you work as a site:
a. who will do monitoring visits
b. how long monitoring visits can last for
c. data entry
d. notice period needed to arrange monitoring visits
Get contact ‘back up’ details from them early, don’t be left without another person to call for queries in cases of sickness, etc.
Provide them with contact ‘back up’ details, so that they get consistency from us.
In meetings if you don’t know the answer be honest and say you’ll find out rather than making something up.
They are there to support you and monitor the safety of the site – they want the best for the site and will help as much as they can.
You and the CRA are the key to running a successful study. You’re the conduit between the Sponsor & the Principal Investigator.