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invoiced. Many of the larger pharmaceutical companies have established contract departments whose responsibilities include ensuring that studies to be contracted are identified early so that the costs which will be incurred are correctly identified and budgeted. |
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Some process must be in place to assure that the decision to contract out a study is taken by the appropriate member of staff within an organization and that the decision and the financial implications are communicated to the financial and project management departments. The costs of clinical studies are such that great care should be given to financial authorization levels of those staff members who will contract out studies. A clear authorization process with strict limits should be in place to allow rapid and proper approval of the expenditure. |
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Once approval to contract has been granted, the first step is to draw up a Responsibility Checklist. This lists all of the activities in detail which the sponsor wishes to retain and those for which the CRO will be responsible. This is a vital document which forms the basis of discussions with prospective CROs and the basis for the final contract. It is vital that this be completed by each group affected within the sponsor company. The list should start with all those activities needed to prepare for a study, including study design, protocol preparation, CRF design, investigator brochure production, etc., through to sections on study management, study initiation, study conduct, data analysis, and reporting. All aspects of the study must be covered to avoid misunderstanding and confusion of responsibilities, at a later date, between the CRO and sponsor. |
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It is essential that the Responsibility Checklist be fully communicated throughout the sponsor company and agreed to by each group within the company. The Data Management department must be aware and involved if a study is to be contracted out even if they will not be conducting the analysis themselves. They must agree to the specifications of the data base to be used by the CRO and other aspects. Similarly, the clinical team members must be aware and involved if the analysis of a study is to be contracted out. In fact, the formation of a project team with representatives from each of the functions to agree on the Responsibility Checklist and to agree to the choice of CRO is recommended. In those companies which have chosen to form contracts departments, it is the responsibility of those staff members to ensure that such a team is formed and that decisions taken are communicated effectively throughout the company. |
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Timings required by the sponsor must be agreed to internally before being communicated to CROs. The team approach mentioned is, again, suggested to facilitate agreement. The timings agreed upon must be achiev- |
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