Investigative site management

PART 4 - LEVEL OF INVESTIGATION - Completed by Site Manager... 

Site management organizations provide physician investigators, qualified patients, and support personnel for inpatient and outpatient clinical trials for single site or multicenter clinical trials. These firms provide services to sponsors and CROs. They are included in the CRO industry revenue totals, and unlike CROs they incorporate per pahent grant funds in their revenues. 

A team leader should be objective, independent, and competent in both administrative and managerial skills as well as technical incident investigation skills. Many of the leader s activities involve coordination and communication with both the team and others, including site management. 

This trained pool of site management personnel, investigation support personnel, and potential investigation team members will now be ready to respond when needed. 

Test facility management Test site management Sponsor Study director Principal investigator Quality assurance program Standard operating procedures Master schedule... 

Laboratory safety data When the CRFs arrive at the data manager s office, questions will arise relating to laboratory safety data. Queries may occur at the investigator site and advice can be requested from the pharmaceutical physician associated with the clinical trial in the sponsor company. 

At the completion of the inspection, it is customary to have a wrap-up meeting or exit conference between the officials of the firm and the FDA investigator(s). In general, it is best to keep the number of participants in this meeting small. It should be limited to those who played a key role in the inspection, as well as corporate management from QA, regulatory, and site management. 

These service providers hope to offer sponsors efficiencies and cost savings through the improvement of a specific study conduct responsibility. The major weakness in these services is that they lack management controls over the principal investigator, the research facility, and the investigative site personnel. These providers are essentially only enhancing a part of the total study conduct process and, therefore, have only a limited impact on the overall process. In addition, there is some criticism that these providers lack the ability to transfer efficiencies across projects. Each time a study is initiated, these providers must often reinvent the wheel. 

The SMOs in this group own and operate the sites in their network. These providers primarily vary by whether each site in its network has a staff physician serving as the principal investigator, or whether the center primarily contracts with area physicians to fill the role of the principal investigators. Corporate-owned SMO providers that do not have staff medical directors will typically staff each of their centers with a site manager, study coordinators), and, lately, patient recruitment specialists. Physicians are paid on a fee-for-service or hourly basis. Depending on the trial, patients are seen either at the physician s office or at the SMO s own facilities. 

A major weakness of the physician-owned SMO is that the company doesn t have tight control of its study conduct operations being carried out at each investigative site in the network. The common difficulties in managing... 

Only a handful of providers are pursuing this approach. Two midsized CROs and several small CROs currently own and operate site networks. There are a number of criticisms of the hybrid SMO approach. Several industry observers have commented that project management and study conduct services require unique and distinct skill sets that cannot be integrated. Others argue that the hybrid SMO has been slow to catch on, because a conflict of interest exists when investigative sites are monitored by the same company that owns them. Several industry observers believe the hybrid SMO will be unable to pursue a sizable portion of the overall clinical grants market because it competes with traditional CROs that are reluctant to place studies there. Therefore, the hybrid SMO may have constrained growth potential. 

Discrepancy reports are prepared for investigator review and correction. The sponsor translates the computer output into user-friendly reports. There is direct communication between the investigational site coordinator and the data manager for any error messages that may need clarification. 

To prepare successful CRFs, the sponsor s staff must know typical clinical practices, therapeutic conventions, investigator and staff needs, data management and analysis plans, project-specific definitions and procedures, CRF completion problem areas, remote data/electronic entry and review and approval procedures for CRFs. Ideally, CRFs should be pretested with internal and external experts (e.g. investigational sites). 

There is a whole host of SOP topics for the investigative site, ranging from study management to patient recruitment to handling of accounts receivable. Some study management SOPs appear in Figure 11.4 (Miskin and Neuer, 2002). 

Figure 11.4 Some study management SOPs [Source Miskin and Neuer, How to Grow Your Investigative Site, 2002]...

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