Table 1.
Method | Definition |
---|---|
On-site monitoring | All data errors were regarded as theoretically detectable due to on-site CRAs accessing all source documents |
R2BM | Only data errors in the uploaded photographs were regarded as theoretically detectable since the remote CRA could access only source documents uploaded to the cloud location |
Data review by DM | Only data errors, such as typographical errors, contradiction in data between eCRF data, and data entered not following eCRF completion guidelines, were regarded as theoretically detectable since the DM could not access any source documents |
R2BM remote risk-based monitoring, DM data manager, CRA clinical research associate, eCRF electronic case report form