Page 191 - 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
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the procedures to be followed for maintaining four types of study logs:
1. Screening Log
2. Enrolment Log
3. Study Team Delegation Log 4. Monitor Visit Log
The procedures outlined in this document are to be utilized to provide a generalizable template that can be further edited based upon the specific Sponsoring Agencies requirements.
2. INTRODUCTION
Study logs are essential documents that are generated throughout the various stages of a clinical trial, including before the study becomes active, throughout the duration of the trial, and after the study has been closed, completed, or terminated.
Study logs serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice (GCP) and with all applicable regulatory requirements. Each log allows the research functions to be tracked and appropriately documented.
The study logs are routinely monitored and audited by the sponsor and the regulatory authorities as part of the process to confirm the validity of the trial conduct and integrity of the data.
3. SCOPE
This SOP applies to all clinical research staff on the study team that conduct clinical research at Children’s Health System of Texas (CHST). The study team as defined in Children’s Health Clinical Practice Policy 7.12, Responsibilities of the Research Team will ensure adherence to this SOP.
4. RESPONSIBILITIES
The development and maintenance of the study logs is the responsibility of the study’s primary research coordinator, per GCP requirements. Similarly, the responsibility of maintaining study records including the study logs is outlined in the Children’s Health policy 7.12. This responsibility is also defined by the phase of the study, wherein the study coordinator or study associate must create the study logs before the study is active, they must update the study logs with each relevant event pertaining to each of the corresponding study logs, and they must adhere to the expectations and guidelines for each study log and record once the study is no longer open.
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