Convex CRO offers a full range of monitoring services for single-center or multicenter studies:
Convex monitoring team consists of full time Clinical ResearchAssociateswho guaranteeup-to-date knowledge of the clinicaltrials’ status at eachclinical site.Our monitoring proceduresinclude:
Convex CRO monitoring visits are generally referred to aspre-study visits,initiation visits,periodic monitoring visits, andclose-out visits. A pre-study visit may not be required when a study site is well known to the sponsor; initiation visits may be replaced by an Investigator Meeting attended by the PI and Clinical research staff.
A pre-study visit takes place after a potential PI indicates interest in a specific clinical trial. The purpose of this visit is to determine the site’s ability to conduct the study. Before the visit, the PI should review the protocol and Investigator’s Brochure and sign the Confidentiality Agreement. During the visit, the Convex CRA will meet with the PI and CRC to verify that they have adequate time to devote to the study, have access to the appropriate subject population, and are not involved with competing clinical trials. The CRA will tour the facility to evaluate its adequacy and determine the availability of protocol-required equipment. The CRA will also evaluate the facility’s suitability for subject enrollment and follow-up, investigational product storage, and data form storage. Other study-specific requirements, such as access to an ECG laboratory or the facility where study-required scans will be performed, will be evaluated as well.
Topics for the Pre-Study Visit:
In some cases, such as when the investigative site is already known to the sponsor/CRA, the sponsor may allow a pre-study evaluation to be performed over the telephone instead of on-site. Overall pre-study visit is meant simply to assess the feasibility of conducting the study at the site and determine whether the site can manage protocol-specific requirements, this visit does not itself obligate the PI or the sponsor to work together on the trial.
Once the PI agrees to participate in the study and signs the contract with the sponsor, regulatory documents are accepted by the sponsor, the protocol and consent form are approved by the RA/EC, and clinical supplies are shipped to the site, a studyinitiation visitcan be initiated. This visit verifies that the investigator and other site study personnel understand the investigator’s obligations, the protocol, and the investigational product being studied. During theinitiation visit, the CRA meets with the PI, sub-investigators, the CRC, and other personnel related to the study, such as pharmacy and laboratory staff.
Topics for the Initiation Visit:
After one or more subjects are enrolled in the study, a monitoring visit is scheduled to evaluate how the study is being conducted and to perform source document verification. The number of visits will be determined by several factors outlined in the monitoring plan, including the number of subjects enrolled and the percentage of records that require on-site review and source document verification.
Topics for Periodic Monitoring Visits
When contacting the CRC to schedule a periodic monitoring visit, the CRA will request that subject data forms and SAEs forms for subjects enrolled since the previous monitoring visit be made available. Signed consent forms and source documents should be available as well for review and source document verification. To prepare for aperiodic monitoring visit, the PI and CRC should confirm that the following activities have been completed in order to ensure a productive monitoring visit takes place:
Checking data against source documents, clarifying discrepancies and misinterpretations on data forms, and observing and providing practical ideas for implementation of the protocol at specific sites make periodic monitoring visits an integral aspect of a successful clinical trial. The Periodic Monitoring Visit Checklist on the following page is an example of one that may be used by a CRA when conducting a site monitoring visit.
Topics for a Close-Out Visit:
Site Visit Report
Upon monitoring visit completion, CRA submits a comprehensive site visit report to the sponsor or sponsor-designee. This report lists all findings at the site. Any issues, protocol violations, or other tasks will be described, as well as proposed corrective actions and timelines for making the changes.
Follow-up Letter to the PI
Findings from the site visit are summarized in a follow-up letter to the PI. He/shereviews the letter to make sure they agree with the stated findings and suggestions to resolve deficiencies or corrective actions. The follow-up letter should then be kept in the site study file.