Specifications, worksheet

There are several types available as illustrated in Figures 7-39A, B, and C. See Figure 7-40 for 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. 

The Remedial Action Priority System (RAPS) and Multimedia Environmental Pollutant Assessment System (MEPAS) are different names for an objective exposure pathway evaluation system developed by Pacific Northwest Laboratory to rank chemical and radioactive releases according to their potential human health impacts. Constituent migration and impact are simulated using air, groundwater, overland, surface water, and exposure components based on standard assessment principles and techniques. A shell allows interactive description of the environmental problem to be evaluated, defines required data in the form of problem-specific worksheets, and allows data input. The assessment methodology uses an extensive constituent database as a consistent source of chemical, physical, and health-related parameters. 

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. 

An example FHA analysis worksheet is shown in Figure 2.31. This particular FHA analysis worksheet utilizes a columnar-type format. Other worksheet formats may exist because different organizations often tailor their FHA analysis worksheet to fit their particular needs. The specific worksheet to be used may be determined by the SSP, system safety working group (SSWG), or the FHA customer. 

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