Page 192 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration Department SOP No: R-Reg-103 SOP Title: Creating Study Logs
5.
SPECIFIC PROCEDURES
5.1 Screening Log: This log is important for tracking all potential subjects who were pre-screened for eligibility prior to consenting and screening for the study, as well as those subjects who enroll upon signing consent and then completed the screening procedures to verify their eligibility for the study. Subjects who are determined ineligible are entered on the screening log as a screen failure and those subjects who are determined to meet all inclusion criteria and none of the exclusion criteria are subsequently recorded on the enrollment log as active subjects.
The FDA and GCP do not require a mandatory organization for the screening logs. Where there is variability among what information is included in the screening logs, the following items, including, patient name, patient MRN, patient date of birth, date of screening, eligibility, and reason for screen failure, are typically presented as columns in the screening log. Each newly screened subject is entered on a new row. Please, see the example below:
SCREENING LOG
Protocol Title:
Protocol No:
Site Name:
Sponsor:
Principal Investigator:
Name
MRN
DOB
Date of Screening
Eligible Y or N
Reason for Screen Fail
John Baker
0000012
01/01/15
01/01/16
Y
Andy Garcia
0000023
01/02/15
01/02/16
Y
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