Standard operating procedures

Standard operating procedures (SOPs) are detailed, written instructions aimed at achieving uniformity in the performance of specific functions.

Definitions

ICH E6(R2)

1.55 Standard Operating Procedures (SOPs):

Detailed, written instructions to achieve uniformity of the performance of a specific function .

Overview of standard operating procedures (SOPs) in clinical research

Types of SOPs

SOPs can cover a wide range of activities, including rules for:

• creating and reviewing clinical trial protocols, manuals, and guidelines
• strategies for recruiting and retaining study participants
• procedures for obtaining and documenting informed consent
• procedures for reporting adverse events and adverse drug reactions
• conducting study monitoring activities
• clinical data collection, entry, verification, and storage

Preparation of SOPs

Various stakeholders are responsible for the preparation of SOPs.

Sponsors are responsible for developing and approving SOPs that govern the conduct of their clinical trials. Contract research organizations (CROs) often develop SOPs tailored to the specific needs of their clients and studies.

Institutional review boards (IRBs) may have their own SOPs related to the review and approval of research protocols. Research institutions, hospitals, and trial sites also develop SOPs specific to their operations and regulatory requirements.

Compliance with SOPs

Regular training sessions for each person subject to a specific procedure ensure that they understand and can implement the SOPs. Detailed records of all procedures, deviations, and corrective actions document adherence.

Continuous monitoring of the research process ensures that SOPs are being followed, while periodic reviews and updates of SOPs reflect new regulations, technologies, and best practices. Regular internal and external audits and inspections verify adherence to SOPs and identify areas for improvement.

Policies vs standard operating procedures (SOPs) vs working instructions (WIs)

Policies, SOPs, and working instructions (WIs) are essential components of an organization’s operational framework, each serving distinct purposes.

	Policies	SOPs	WIs
Hierarchy	Policies are high-level documents, overarching principles that guide decision-making and behavior within an organization	SOPs are mid-level, detailed instructions that describe the specific steps required to implement policies and ensure consistency of procedures	WIs are the most detailed level of documentation, providing precise instructions on how to perform specific tasks or use certain equipment
Purpose	Policies provide a framework for the consistent application of rules reflecting the organization’s values, goals, and legal obligations	SOPs ensure uniformity and standardization in the performance of tasks across the organization	WIs ensure that tasks are performed correctly and efficiently by providing detailed guidance
Scope	Policies apply broadly across the organization	SOPs apply to specific processes or procedures	WIs apply to individual tasks, roles, or pieces of equipment
Example	A policy might dictate that all clinical trials must adhere to ethical standards and regulatory requirements	An SOP might outline the step-by-step process for obtaining informed consent from clinical trial participants	A WI might provide detailed instructions on how to calibrate a specific piece of laboratory equipment

See also

Links to this page

• SOP (redirect page) ‎ (← links)