The PI is responsible for ensuring that the source data is accurately recorded in the electronic Case Report Forms (eCRFs). This accurate transposition of data is critical to maintaining data integrity and ensuring that the data collected at the site is consistent with the reported clinical outcomes.
GCP guidelines specify that source data should be accurate, legible, and directly reflected in the CRFs to maintain consistency and reliability.
"The PI must ensure that the source data are accurately and completely recorded in the eCRFs to maintain data integrity."
Objectives:
Ensure accurate data transposition from source to CRF.
Maintain high standards of data quality and reliability.
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