Site
prequalifications – If you are conducting a multi-site trial, we can
assist you in ensuring the site has the proper qualifications, subject
population, and necessary resources needed to successfully participate in
your research study. We will collect the necessary documentation needed
prior to study initiation. We will travel to the site and report on our
recommendations to the PI and sponsor-representative. *Note: all travel
expenses incurred are the responsibility of the investigator.
Before the Trial
Starts – We will assist the investigator in preparing the essential
documents that will be needed to conduct the trial. These include source
documentation flow sheets, Case Report Forms, drug accountability forms, and
other logs needed to track the progress of the study. We will assist the
coordinator with setting up their regulatory files for this study.
Site Initiation
Visits – When you are ready to begin your trial, we will work with
the investigator and his/her staff to help get the trial started. We will
assist in educating the members of the research staff in the
protocol-specific details. This includes protocol review, investigator
responsibilities, informed consent process, regulatory documents, source
documentation requirements, drug accountability and storage, and case report
form completion.
Periodic Monitoring
Visits – Once your trial has began, we will schedule monitoring
visits approximately every 8-12 weeks to review data collection, regulatory
binders, and drug accountability. These monitoring visits help the
investigator identify problem areas with the study and they are able to
correct the problems before they get out of control. We are not auditors.
Our goal is not be punitive, but supportive. We will spend 1-2 days
reviewing the records and at the end of each visit, we would like to meet
with the investigator for a few minutes just to relay what we found during
the visit. A formal letter with details of the findings will be issued
within a week of the visit.
During the conduct
of the trial – The monitoring unit will assist the research team
with any protocol amendments, consent form changes, or case report form
changes that are needed. We can also assist in correcting any problems with
the study through education of the study staff.
Final Close-Out
Visit – At the end of your study, we can conduct a final monitoring
visit to verify all data has been collected and is accurate, we will perform
drug accountability and ensure any remaining drug is destroyed or returned
to the manufacturer, and we will review all regulatory documents to ensure
the file is complete in the event of an audit.
Audit Preparation
- Should the study be audited by an internal auditor or the FDA, we can
assist in making sure the site is prepared for that audit.
