The DMP (data management plan) will generally take action once the data management group has received the data, including glare and cleaning. The DMP will also consider whether the data should be integrated into the EDC system. DTAs received by external party researchers for incoming data sets must be verified by a member of the contract team at the research office, before the data is transferred, as the conditions must be carefully verified for applicable funding conditions. In our experience, data is easier to understand and clean during integration because the integration activity initiates the cleanup process. In each clinical trial, data are often collected electronically, but do not fall within the scope of the eCRF. This data includes key laboratory results such as ELECTROGs, PK/PD data and others. In this blog, we will take a look at some important thoughts regarding the management of electronic data transfers and each subsequent integration into the EC`s central database. The following factors influence TPVL`s preference for clinical trials: the eighth data protection principle (see list of the Data Protection Act) requires that personal data cannot be transmitted outside the European Economic Area (EU Member States, Iceland, Norway and Liechtenstein) unless the country or territory where the data is to be transferred provides an adequate level of protection for personal data. One of the exceptions is that you have permission to do so.
Therefore, it is important that you have specified in your participant information sheet and consent form that the data can be transmitted outside the UK or EEA. When deciding whether integration should be implemented or not, it is important to understand that external data can change over time. It is therefore necessary to develop explicit guidelines for data processing and to share them with the relevant teams. There are also schedules and budgetary aspects that need to be taken into account, and cytel clinical data management experts are able to provide instructions on how best to adapt to the requirements of a given study. First, when data is transmitted by third parties, a data transfer contract (dtA) must be put in place. The DBA should at least include sections: The transfer and use of personal data is a complex subject that cannot be adequately addressed on this site. Duke researchers who wish to transfer or use personal data should contact the ORC to initiate a debate on the transfer or use of the proposed data. Key factors in selecting laboratory providers for clinical trials include [Figure 2]: whenever possible, it is good practice for research to be conducted on coded or completely anonymized data.