Improving site coordinator, study monitor relationship
Improving site coordinator, study monitor relationship
Talk among thyselves
The sponsor and sponsored site have a relationship that is tended during a study by the study coordinator and the study monitor. If their communication and trust are good, then the study benefits from this relationship. If not, then there could be problems.
"Communication is key," says Stacey Basham, RN, RQAP-GCP, president of Rialto Quality Group of Alexandria, VA.
Site coordinators should talk with monitors during site visits, quickly address any corrective actions, and document everything, she says.
Here are some of Basham's other suggestions for how to improve the coordinator monitor relationship:
Know which questions to ask a monitor and which questions to answer: "Generally you should know the scope of the visit based on earlier communication from the monitor," Basham says. "For example, the monitor might say the focus of the visit is accountability."
Monitors check during the visit to make sure the site is doing drug accountability correctly, and coordinators should follow-up with monitors to make certain their site is on track and doing the accountability correctly, she suggests.
For example, if a trial participant says he took 20 doses of a study drug and this comes in a pack of 25 doses, coordinators should have five doses left in the pack to verify the numbers match, Basham explains.
Return or destroy?
Plus coordinators should know or ask monitors about whether they should return remaining product or destroy them at the site. And the monitor should check these drug packs before completing the visit.
"If you have a collection of drug pack returns, know where they are in accountability and how soon you can send them back," Basham says. "These are important to know when you are sitting down with your monitor."
The monitor is responsible for making sure accountability records reflect what's at the site so every pill and dosage is accounted for, she adds.
When the monitor has finished the visit, the study coordinator might ask for information about any findings that possibly could be corrected while the monitor is still there, she suggests.
"I know everyone is busy, and you don't want to be disruptive, but the coordinator should try to do an end of the day meeting with the monitor before the monitor leaves," she says. "Try to learn some of the findings at the visit instead of waiting for a letter to arrive later."
Then if there are some findings, the coordinator should ask the monitor for suggestions on how to resolve these issues.
"Maybe the protocol is asking for documentation of telephone contact, and it doesn't say how to do this, so the coordinator could ask the monitor for a suggestion," Basham says. "Also, find out when the next visit will be and when the monitor will need to meet with specific staff members, such as the pharmacist."
Make time for the monitor during site visits and facilitate smooth communication: "Try to put that visit into your work practices," Basham says.
During a site initiation visit or the first meeting with the monitor, a study coordinator should sit down with the monitor to discuss how they want communication to flow. This prevents miscommunication problems.
For instance, if a monitor says she'll send out findings about a week after a site visit, then the coordinator should follow-up with an email after six or seven days, saying the report hasn't arrived.
"Make sure you know the monitor's expectations and the monitor knows yours," Basham says. "Find out when the monitor will want to meet with the principal investigator is it every visit or every third visit?"
"If a monitor likes to communicate by email on Thursday afternoons, then that's how it should happen," Basham says. "Find out how the monitor will provide follow-up."
An ideal communication plan within the monitoring plan is having weekly communication between the monitor and site, Basham notes.
"Email is the most advisable because it's written down and it stays there," she adds. "I don't recommend texting."
There will be some phone calls between coordinators and monitors, but coordinators should keep in mind that emails provide verification that your message was heard and remembered.
"If a monitor is boarding a plane and sees her email about a visit, then she knows that as soon as she reaches her destination she can add the appointment to her calendar," Basham explains. "Plus it's an easy way to respond."
Consider all options
Other communication options include how sites should respond to monitors' follow-up letters and findings.
"Once the follow-up letter is received, the site may communicate with the site monitor how they'll follow-up with the items," Basham says.
Also, coordinators should ensure there is open and ongoing communication between themselves and monitors. If a monitor's follow-up letter includes items that a coordinator doesn't clearly understand, the coordinator should contact the monitor and ask for a clarification.
"It might be the subject listed is number 139, but the letter says number 193," Basham says. "You should have good communication so you can say, 'Did you mean this patient or that patient?'"
Coordinators should identify the quick fixes and then document how they made them, she adds.
"If something is missing, or if there's a data transcription error, then go in and change the eight to a nine," Basham says. "Or if something further is needed, add a progress note."
All documentation should identify what the issue was, what was done about it, and explain everything clearly and concisely.
It's also up to coordinators to resolve issues with monitors who are behind in communication.
If a monitor's follow-up information remains slow despite a coordinator's repeated emails and calls, then escalate the issue by talking to the next manager, Basham suggests.
"If the monitor consistently is showing up for another visit while you're waiting for a follow-up from six weeks ago, then go to the monitor's manager," she says.
At the close-out visit, study coordinators or other representatives at the site should be aware of any monitoring, follow-up letters received in which there are unresolved questions or issues.
"Make sure everything has been closed out, including what's in the follow-up letters and set time parameters," Basham says. "Make sure any findings that have not been addressed are taken care of."The sponsor and sponsored site have a relationship that is tended during a study by the study coordinator and the study monitor.
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