Based on ICH-GCP guidelines definition, essential documents are “those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced”. In order to successfully manage a clinical trial, it is critical to file the essential documents in a timely manner. The purpose of the regulatory binder is to provide an organizational framework for filing essential documents. Usually the regulatory binder is shipped to the clinical site prior to the site initiation visit (SIV). Once the clinical site receives the regulatory binder, the clinical research coordinator (CRC) will maintain and update it. Different logs are part of several documents filed in the regulatory binder. The following are list of most common logs included in the regulatory binder:
Training Log;
The Clinical Research Associate (CRA) is responsible to train the Principal Investigator (PI) and CRC on the protocol. The first training is provided during the SIV and is also required after any protocol amendment. The log is completed after every training. Once the study coordinator and PI were provided with an adequate understanding of the study, they can train other study staff.
Delegation of Responsibility (DOA) Log;
Each staff in the clinical site is responsible for a specific study procedure. Any changes in the responsibilities including adding new staff and removing the previous staff that no longer work in the clinical site/study should be documented in this log.
Monitoring Log;
The purpose of monitoring log is to record the site visits and at the end of every monitoring visit this log needs to be signed by the CRA and CRC. If the monitoring visit occurs over than one day, the log should be signed separately for each day.
Screening/Enrollment Log;
There is a screening phase prior to enrollment of subjects; any subject who have been screened for the study needs to be entered in this log.
Subject Visit Tracking Log;
The subjects who have signed the consent form should be entered in this log.
Investigational Product (IP) Accountability Log;
The following information is included in the IP log: product lot number, expiration date, the date IP was dispended and returned, amount of dispensed IP, remaining amount of the IP and the initials of whom dispended the IP and completed the log.
Overall, it’s the CRC responsibility to ensure that all logs are updated after any recordable event and the logs should be approved and signed by the PI. During the monitoring visits, the logs are reviewed by the CRA to make sure they are in compliance with the GCP guidelines.