1. Study Staff Not in the Direct Employ of the Investigator
Staff involved directly in the conduct of a clinical investigation may include individuals who are not in the direct employ of the investigator. For example, a site management organization (SMO) may hire an investigator to conduct a study and provide the investigator with a study coordinator or nursing staff employed by the SMO. In this situation, the investigator should take steps to ensure that the staff not under his/her direct employ are qualified to perform delegated tasks and have received adequate training on carrying out the delegated tasks and on the nature of the study ,or the investigator should provide such training. The investigator should be particularly cautious where documentation needed to comply with the investigator’s regulatory responsibilities is developed and maintained by SMO staff (e.g., source documents, CRFs, drug storage and accountability records, institutional review board correspondence). A sponsor who retains an SMO shares responsibility for the quality of the work performed by the SMO.
The investigator is responsible for supervising the study tasks performed by this staff, even though they are not in his/her direct employ during the conduct of the study. This responsibility exists regardless of the qualifications and experience of staff members. In the event that the staff’s performance of study-related tasks is not adequate and cannot be made satisfactory by the investigator, the investigator should document the observed deficiencies in writing to the staff member’s supervisor(s) and inform the sponsor. Depending on the severity of the deficiencies, the clinical trial may need to be voluntarily suspended until personnel can be replaced.
b. Parties Other than Study Staff
There are often critical aspects of a study performed by parties not involved directly in patient care or contact and not under the direct control of the clinical investigator. For example, clinical chemistry testing, radiologic assessments, and electrocardiograms are commonly done by a central independent facility retained by the sponsor. Under these arrangements, the central facility usually provides the test results directly to the sponsor and to the investigator. Because the activities of these parties are critical to the outcome of the study and because the sponsor retains the services of the facility, the sponsor is responsible for ensuring that these parties are competent to fulfill and are fulfilling their responsibilities to the study.
Less frequently, a study may require that investigators arrange to obtain information critical to the study that cannot be obtained at the investigator’s site. For example, if the study protocol requires testing with special equipment or expertise not available at the investigator’s site, the investigator might make arrangements for an outside facility to perform the test. In this case, the results are usually provided directly to the investigator, who then submits the information to the sponsor. If the investigator retains the services of a facility to perform study assessments, the investigator should take steps to ensure that the facility is adequate (e.g., has the required certification or licenses). The investigator may also institute procedures to ensure the integrity of data and records obtained from the facility providing the information (e.g., a process to ensure that records identified as coming from the facility are authentic and accurate). Procedures are particularly important when assessments are crucial to the evaluation of the efficacy or safety of an intervention or to the decision to include or exclude subjects who would be exposed to unreasonable risk.
Investigators should carefully review the reports from these external sources for results that are inconsistent with clinical presentation. To the extent feasible, and considering the specifics of study design, investigators should evaluate whether results appear reasonable, individually, and in aggregate, and they should document the evaluation. If investigators detect possible errors or suspect that results from a central laboratory or testing facility might be questionable, the investigator should contact the sponsor immediately.
c. Special Considerations for Medical Device Studies
Field clinical engineers (device sponsor employees) have traditionally played a role in some investigational device procedures (e.g., cardiology, orthopedics, and ophthalmology) by providing technical assistance to the device investigator. The field clinical engineer should be supervised by the investigator because the field clinical engineer’s presence or activities may have the potential to bias the outcome of studies, may affect the quality of research data, and/or may compromise the rights and welfare of human subjects. The field clinical engineer’s activities should be described in the protocol. If the field engineer has face-to-face contact with subjects or if the activities of the field engineer directly affect the subject, those activities should also be described in the informed consent.
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