Sponsors, role

Despite the sponsor and CRO s best efforts to predict all aspects of the study, there often arise occasions on which the study requires CRO services that exceed expectations. In these cases, the sponsor must be prepared to negotiate a change order agreement to cover the expenses of additional CRO services. In certain cases, the sponsor may approve a change order that amends the study timeline. Sponsor roles and responsibilities are summarized in Table 54.4. 

We view the sponsor as a logical head for the project Steering Committee in an organization such as that shown in Figure 15.4. The sponsor should not be on what we refer to in Figure 15.4 as the Design Team. Table 15.3 summarizes the sponsor role. 

Internal methods of quality assessment should always be viewed with some level of skepticism because of the potential for bias in their execution and interpretation. For this reason, external methods of quality assessment also play an important role in quality assurance programs. One external method of quality assessment is the certification of a laboratory by a sponsoring agency. Certification is based on the successful analysis of a set of proficiency standards prepared by the sponsoring agency. For example, laboratories involved in environmental analyses may be required to analyze standard samples prepared by the Environmental Protection... 

The American Institute of Chemical Engineers (AICliE) wishes to thank the Center for Chemical Process Safety (CCPS) and those involved in its operation, including its many sponsors whose funding and technical support made this project possible. Particular thanks are due to the members of the Batch Reaction Subcommittee for their enthusiasm, tireless effort and technical contributions. Members of the subcommittee played a major role in the writing of this book by suggesting examples, by offering failure scenarios for the major equipment covered in the book and by suggesting possible solutions to the various Con-cerns/Issues mentioned in the tables. 

The following section provides some suggested ways to use management commitment and may help you further define the role you propose for your company s senior PSM sponsor. 

There is a whole range of measures you can take to rriinimize or erase fears such as this. First of all, educating all of your employees with regard to the role of a mentor is highly important - sponsoring employees is not an aspect of a mentor s role, at least not in a European context. It is equally effective to... 

Who would you like to involve in the design and implementation phase, i.e. who would your steering committee consist of List all the different roles associated with the implementation of the scheme (see below), and make temporary suggestions as to who you would like to fill these emphasize that the scheme s sponsors should also form part of the steering committee. 

In the above checklist, we mentioned that you should explain the function of the steering committee or implementation team (as it is also sometimes called) to the audience you are proposing to. In addition, we suggested that you advise the scheme s sponsors, to whom you are proposing, on the roles typically associated with it, and that you encourage them to join the committee. 

Scheme sponsors such as senior management, line managers and external clients All briefing on scheme. Line managers only briefing on role... 

The scope of the scheme - how many people are involved in running the scheme Who are these people and what roles do they occupy How many participants (mentors and mentees) will be involved in the scheme Who else will have an impact on the scheme (e.g. line managers and sponsors) ... 

Sponsor companies use quality assurance units independent of the clinical research group to audit medical operations. Their role is to ensure that regulatory standards and company policies and procedures for clinical research are being followed in all countries where research is being conducted. 

In the current, price-sensitive environment, which is the hallmark of modem healthcare and certainly new drug development, expenses necessary to support clinical research are a major concern for sponsors. Both fixed and variable costs can be managed effectively compared to complete in-house development budgets. As product development costs are a significant element influencing pharmaceutical pricing, the role of innovative CROs is expected to grow. 

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