Site Monitor Visits
Study sites are monitored to ensure oversight of the clinical research study by the sponsor. Regular site monitor visits can be broken down into four types: pre-study visits, initiation visits, periodic monitoring visits, and close-out visits. Study sites may also be monitored or audited by the FDA, Clinical Research Organizations (CROs), IRBs and sponsors. For more information on site audits by outside entities please visit the training documents on Quality Management: Audits.
Pre-study visits (site selection visits or site qualification visits (SQVs)) are conducted to determine if the investigator and clinical site have the capability to conduct the study. During this visit, both an investigator and a study coordinator must be available. When applicable, pharmacy staff may also need to be available. The monitor will usually request a tour of the facility and time to discuss the basic fundamentals of the protocol and how that relates to the feasibility of recruiting potential participants.
Other topics of discussion during the pre-study visit include:
- Investigator responsibilities
- Qualifications of investigator or other site personnel
- Study objectives, protocol-required procedures, eligibility criteria, and patient recruitment
- IRB (e.g., informed consent requirements)
- Adverse event reporting, source documentation, and record retention
- Space requirements, availability of a secure area to store investigations drug or devices, availability of required equipment
A Site Initiation Visit (SIV) is when the research study team receives adequate training from the sponsor or CRO on the protocol. It is also the opportunity for the sponsor or CRO to ensure that the investigator fully understands his/her responsibilities (21 CFR 312 Subpart D). This visit usually occurs after the site has completed all regulatory requirements and has obtained IRB approval for the research study at their site. The initiation visit is the last step before the study site is activated for enrollment by the sponsor.
During study start-up, a sponsor may choose to hold an investigator meeting for a large number of sites in lieu of conducting many site initiation visits. If you are required to travel to an investigator meeting for a study, visit the Office of Sponsored Programs (OSP) for OSU’s travel policies.
Other topics of discussion during the site initiation visit include:
- Study overview, eligibility criteria, procedures, access to suitable patient population
- Lab manual, requirements for research sample processing and shipping
- Regulations and Good Clinical Practice (GCP) guidelines, informed consent requirements, IRB obligations, adverse event reporting, drug accountability
- Data forms review including Case Report Forms (CRFs)
- Regulatory documents and study file organization
- 21 CFR 312 Subpart D Responsibilities of Sponsors and Investigators
- OSP Travel
Periodic Monitoring Visits
The sponsor and/or CRO will develop a monitor plan that includes the frequency and duration of periodic monitor visits. The focus of these visits is to evaluate the way the study is being conducted and to perform source document verification. These visits can occur every few weeks to once a year and can take less than one day up to several days at a time. It is important to be familiar with the contract agreements, as they may contain the agreement as to the frequency and duration of site monitoring visits and the sponsor’s data entry expectations. The contract agreement should match what the sponsor and/or CRO creates in the site monitor plan.
At the beginning of the study, it should be determined where the monitor or monitors will work while they are on site. Ideally, the monitor should have their own workspace separate from the research study team. In addition, many monitors require internet access for their laptops. Instructions for OSUMC guest wireless can be found here.
Preparing for a periodic monitoring visit:
- Identify a quiet place for the monitor to work and ensure access to a copy machine, phone, water fountain, and restroom
- Complete all necessary CRFs
- Confirm that Serious Adverse Event (SAE) forms have been submitted and are available for review
- Obtain medical records for the CRFs to be reviewed
- Organize study file documents for review
- Confirm that signed consent forms for all enrolled participants are available
- Schedule an appointment for the monitor to visit the pharmacy if needed
- Schedule time for the study coordinator to meet with the monitor towards the end of the visit to review findings
- Schedule time for the investigator to meet with the monitor towards the end of the visit to review findings
When the research study has been completed at a site, a close-out visit occurs. This type of visit can take the form of an on-site visit or, in some cases, be conducted via a telephone call. Some close-out visits are also combined with a final periodic monitoring visit.
Action items during the close-out visit may include:
- Discuss timelines and strategies for the completion of outstanding case report forms and queries
- Return or destruction of study drug
- Collect outstanding patient data forms and study forms such as the screening and monitoring logs
- Perform a final review of the study file documents
- Discuss the plans for record retention
- Discuss ongoing investigator responsibilities
Liu, M.B. and Davis, K.; Chapter 6: Monitoring. Lessons from a Horse Named Jim: a Clinical Trials Manual from the Duke Clinical Research Institute. Durham, NC: Duke Clinical Research Institute, 2001. Print.