Page 193 - 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
5.2 Enrollment Log: This log is important for tracking all subjects who sign the consent form and are determined to be eligible for the study after completing the screening procedures confirming that they meet all inclusion and none of the exclusion criteria. The principal investigator (PI) must sign-off for every subject verifying that all the eligibility criteria are met before the subject can move forward with the study protocol.
The FDA and GCP do not require a mandatory organization for enrollment logs. Where there is variability among what information is included in enrollment logs, the following items, including, patient name, patient MRN, patient date of birth, subject ID number, date of screening, eligibility, date enrolled, date randomized/treatment, and PI initial and date of initials are typically presented as columns in the enrollment log. Each newly enrolled subject is entered on a new row. Please, see the example below:
ENROLLMENT LOG
Protocol Title:
Protocol No:
Site Name:
Sponsor:
Principal Investigator:
Name
MRN
DOB
Subje ct ID
Date of Screenin g
Eligibl e
Y or N
Date Enrolled
Date Randomized / On Treatment
PI Initial & Date
John Baker
0000 012
01/01 /15
001
01/01/16
Y
01/01/16
02/01/16
Andy Garcia
0000 023
01/02 /15
002
01/02/16
Y
01/02/16
02/02/16
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