Corrections made to CRF data after the investigator has signed as above should be and dated by an investigator. eCRF data In the absence of any Sponsor-specific procedures the following procedure may be used or adapted as per trial-specific requirements: eCRFs will only be completed for enrolled subjects unless otherwise decided by the PI or Sponsor. A member of the team designated to perform data entry direct from source documents will ensure that the relevant data have been declared complete by the investigator. Data should be documented in an eCRF data entry tracking log (AD07.1). Prior to the investigator (electronically or otherwise) signing declarations of completeness in an eCRF, a designated team member may oversee a review of all, or a pre-specified selection of, CRF data for accurate transcription. All documentation relating to data recording and quality control will be kept in the Investigator Site File (ISF). Document history: Version No. Date Reviewer Details of changes
Corrections made to CRF data after the investigator has signed as above should be and dated by an investigator. eCRF data In the absence of any Sponsor-specific procedures the following procedure may be used or adapted as per trial-specific requirements: eCRFs will only be completed for enrolled subjects unless otherwise decided by the PI or Sponsor. A member of the team designated to perform data entry direct from source documents will ensure that the relevant data have been declared complete by the investigator. Data should be documented in an eCRF data entry tracking log (AD07.1). Prior to the investigator (electronically or otherwise) signing declarations of completeness in an eCRF, a designated team member may oversee a review of all, or a pre-specified selection of, CRF data for accurate transcription. All documentation relating to data recording and quality control will be kept in the Investigator Site File (ISF). Document history: Version No. Date Reviewer Details of changes