Study specifications worksheet

Figure 54.1 Study specifications worksheet (Reproduced with permission from Vogel and Nelson, 1993)...

The RFP consists of a cover letter, detailed instructions to proposers, a copy of the study protocol, the completed study specifications worksheet, a resource allocations worksheet and a copy of the sponsor s standard CRO agreement. The cover letter should briefly describe the study goal, provide an overview of the clinical plan, specify the proposal due date, indicate that the CRO may be invited to present its proposal orally to the sponsor and specify the timing for the sponsor s reply. The CRO should be given approximately two weeks to prepare a proposal, and the sponsor should expect to reply to the proposals within two weeks. 

The worksheet lists the same 21 service categories addressed by the sponsor in the study specifications worksheet. For each category, the bidder should list the types of personnel who will be involved in performing that service. For each type of personnel, the CRO should define the number of hours/FTEs, the rate charged per unit of time and the total cost for that person to perform that service. 

An example of a study specifications worksheet is shown in Figure 40.1. The first page of the worksheet, entitled Study Details, is designed to provide an overview of the study and includes information on key parameters, such as the number of patients, number of visits, expected enrollment rate, and number of sites. It also includes information on the health-care setting (e.g. academic medical center, private practice or managed care) and the regulatory status of the product. The Materials and Actions section of the worksheet is divided into 21... 

Within each category are several specific activities listed as examples. The sponsor may list as many specific activities as appropriate for the study. For each activity the sponsor should indicate whether that activity will be the sponsor s responsibility or the CRO s responsibility by placing a check in the appropriate column. In those cases where the sponsor feels that the activity will be shared with the CRO, sponsors should examine the activity to determine whether it could be broken down into more discrete items. This will minimize confusion over who actually is responsible for the activity. The last section of the study specifications worksheet is entitled Project Timeline. It contains the sponsor s projected dates for completion of study milestones. Twenty-six suggested milestones are listed the sponsor may wish to modify the list according to its own milestones. 

Y data. The data set used for this example is from Miller and Miller ([1], p. 106) as shown in Table 58-1. This dataset is used so that the reader may compare the statistics calculated and displayed using the formulas and figures described in this reference with respect to those shown in this series of chapters. The correlation coefficient and other goodness of fit parameters can be properly evaluated using standard statistical tests. The Worksheets provided in this chapter series can be customized for specific applications providing the optimum information for particular method comparisons and validation studies. 

The subsystem hazard analysis report contains a description of the subsystem and a narrative summary of key findings that specifically address the adequacy of the controls placed on any high hazards associated with the end products, the level of residual risks that remain after controls have been applied, and recommendations for further analysis or testing. The report should also describe the techniques and methodology used in performing the analysis, including risk assessment and risk acceptance criteria. The report should also contain the hazard report worksheets used in the study. 

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