Standard Operating Procedure for Good Clinical Practices (GCP) Compliance

1) Purpose

This SOP outlines the procedures for ensuring compliance with Good Clinical Practices (GCP) to ensure the safety, rights, and well-being of clinical trial subjects and the integrity of clinical trial data.

2) Scope

This SOP applies to all personnel involved in the conduct, management, and oversight of clinical trials conducted at the facility, including investigators, study coordinators, and clinical research associates.

3) Responsibilities

The Clinical Research Manager or designated personnel are responsible for overseeing GCP compliance. Investigators, study coordinators, and other clinical trial staff are responsible for implementing GCP requirements in their respective roles.

4) Procedure

4.1 Protocol Compliance

1. Review and adhere to the approved clinical trial protocol, including amendments and updates.
2. Ensure that all clinical trial activities are conducted in accordance with the protocol and applicable regulatory requirements.

4.2 Informed Consent Process

1. Obtain informed consent from each trial subject prior to participation in the clinical trial.
2. Ensure that the informed consent process is conducted in accordance with regulatory requirements and that subjects are adequately informed about the trial procedures, risks, and benefits.

4.3 Study Documentation

1. Maintain accurate and complete documentation of all clinical trial activities, including study documentation, case report forms (CRFs), and source documents.
2. Ensure that study documentation is contemporaneous, attributable, legible, original, and accurate (ALCOA principles).

4.4 Investigational Product Management

1. Handle, store, dispense, and account for investigational products (IPs) according to the protocol and applicable regulatory requirements.
2. Maintain adequate records of IP receipt, dispensation, and return, including accountability logs and temperature monitoring.

4.5 Adverse Event Reporting

1. Promptly report and document all adverse events (AEs) and serious adverse events (SAEs) occurring during the clinical trial.
2. Follow procedures for AE/SAE assessment, reporting to regulatory authorities, and communication with trial subjects and investigators.

4.6 Monitoring and Quality Assurance

1. Conduct regular monitoring visits to ensure compliance with the protocol, GCP, and applicable regulatory requirements.
2. Perform internal quality assurance audits to verify the integrity of clinical trial data and compliance with SOPs.

4.7 Study Close-Out

1. Complete all required documentation and procedures for study close-out, including final data verification, archiving of study records, and final report preparation.
2. Ensure that study participants are appropriately informed about study completion and any follow-up procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure
GCP: Good Clinical Practices
CRF: Case Report Form
IP: Investigational Product
AE: Adverse Event
SAE: Serious Adverse Event

6) Documents, if any

GCP Compliance Checklist, Protocol, Informed Consent Forms, Case Report Forms (CRFs), Investigator Brochure, Investigational Product Accountability Records, Adverse Event Reports, Monitoring Visit Reports, Study Close-Out Checklist

7) Reference, if any

Regulatory guidelines such as ICH E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1), FDA Code of Federal Regulations (21 CFR Parts 50, 56, 312, and 314), WHO Handbook for Good Clinical Research Practice

8) SOP Version

Version 1.0