SDM (Site Data Manager) is a specialist who supports data-related tasks primarily in clinical trials at medical institutions with their experience as a Clinical Research Associate (CRA). SDMs prepare source documents, enter data into EDC, and resolve queries at the medical institutions they are assigned to. SDMs help to reduce the workload of CRAs and CRCs and to increase their productivity, enabling both CRAs and CRCs to improve the efficiency of their work. With the support by SDMs, specialists in data-related tasks, data can be managed accurately, and the frequency of monitoring can be reduced in combination with Risk-Based Monitoring (RBM). SDMs can also perform some of the study start-up tasks in collaboration with CRCs leveraging the knowledge and experience that SDMs have gained when working as CRAs. SDMs enable clinical trials to run smoothly.
Leveraging their experience as CRAs, SDMs work with CRCs at medical institutions to handle data-related tasks in clinical trials.
SDMs’ support in checking source documents, preparing some of the source documents, entering data into EDC and query solution enables smooth SDV.
By letting SDMs handle data-related tasks, CRCs can focus on subject visits, improving CRC productivity.
With the perspective gained from CRA experience, the SDM reviews source documents, ensures EDC entry without any deficiencies, and assures the quality of clinical trial data.
SDMs and CRCs anticipate potential risks from the protocol and establish processes for conducting the clinical trial at the medical institution.
Since SDMs have experience as CRAs, the questions from the sponsors are now answered promptly and appropriately.
Because the required data are entered early, the number of inquiries to the CRCs for data entry has decreased. This has improved operational efficiency.
