Source Data Location AgreementSource Data Location Agreement • July 7th, 2018
The agreement should be updated in case routines at site are changed (= should always reflect the current procedures at site).
ENFORCE PLUSSource Data Location Agreement • June 24th, 2021
*) Comment or use the following codes for description of location: SHR: NN: SSDD: Subject Hospital Record Nurses notesSubject Source Data Document LAB: MAC: e-CRF: Laboratory dataMachine print-out (e.g. ECG, CGM) Data entered directly into the e-CRF Diary NA:WS: Subject Diary Not Applicable Work Sheet
ENFORCESource Data Location Agreement • April 22nd, 2021
*) Comment or use the following codes for description of location: SHR: NN: SSDD: Subject Hospital Record Nurses notesSubject Source Data Document LAB: MAC: e-CRF: Laboratory dataMachine print-out (e.g. ECG, CGM) Data entered directly into the e-CRF Diary NA:WS: Subject Diary Not Applicable Work Sheet
Source Data Location Agreement Study Name /Protocol/Plan number: Sponsor:Source Data Location Agreement • November 11th, 2020
This initial agreement should be completed, signed, and dated before study start (= prior to the first subject's first visit), thereafter updated and re-signed in case routines at site are changed during the study (= should always reflect the current procedures at site).
