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and reporting being clearly documented and agreed upon. Other areas where it is important to have written agreements are in the criteria for release of drug supply, and data management guidelines. Once these are agreed to, then, they should become part of the written contract as an appendix along with the protocol. |
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There is debate about the most appropriate level of sponsor management of contracts. For a short Phase I study enrolling a small number of healthy subjects, which is not a first administration-to-human study, it would probably be unreasonable to micro manage the study. However, for a difficult multinational Phase III study, it is not uncommon for the sponsor and CRO to be in daily contact. This involvement, if spelled out at the onset of the contract discussions, should not be seen as a burden by the CRO but welcomed as a measure of the involvement and commitment of the sponsor to the study. |
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It is often overlooked that the progress of the contracted study should be communicated within the sponsor. Senior management has a right to be kept up to date with progress or problems. Good, open, honest communication between sponsor and CRO during all stages of a contract, before and after the award, will ensure that no nasty surprises occur. |
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IX.
What to Do If It All Goes Wrong |
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A.
The Pharmaceutical Company Perspective |
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Even with all the careful planning and optimism at the start of a contract, there will be occasions when things will go wrong. Patient enrollment may be affected by seasonal variability, or staff changes within CRO, the sponsor, or the investigator site can adversely effect the smooth running of the contract; drop out rates are higher than anticipated or a flood results in the loss of patient records at a major site. Clearly some problems cannot be anticipated, and not all problems occur because of a fault within the CRO or sponsor. However, it is prudent at the onset of a project to identify and discuss possible problem areas which are generic to clinical research and development. It is also good practice to have contingency plans for the more obvious problems which might occur. This will save considerable time and effort and, hopefully, resolve issues without missing vital agreed milestones. Any hint of a problem must be communicated immediately by the CRO to the sponsor and vice versa. It is important that, along with reporting the possibility of a problem, the CRO and sponsor should propose solutions, showing that the CRO is committed to the same goals as the sponsor. If the |
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