What documents ensure standardized research study conduct according to Good Clinical Practice (GCP) certification?

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From the Guidelines

The correct answer is D. All of the above. These documents, including the Research Protocol, Operations Manual, SOPs, Contract, and Calendar of Events, are essential for ensuring that a research study is conducted in a standardized manner, as emphasized by the ICH GCP guidelines 1. The Research Protocol outlines the study objectives, design, methodology, statistical considerations, and organization.

  • Standard Operating Procedures (SOPs) provide detailed written instructions to achieve uniformity in the performance of specific functions.
  • The Operations Manual contains practical details on how to implement the protocol procedures consistently across all research sites.
  • A Contract is necessary for outlining the terms and conditions of the research study, including the roles and responsibilities of all parties involved.
  • A Calendar of Events helps to ensure that all study activities are conducted in a timely and organized manner. Together, these documents ensure that all researchers follow the same procedures, which is crucial for maintaining data integrity and scientific validity, as well as protecting the rights and welfare of study participants, in accordance with the ICH GCP standards 1.

From the Research

Essential Documents for Standardized Research Study

To ensure a research study is conducted in a standardized manner, certain documents are essential. These include:

  • Research Protocol: a 'road map' that follows a standard format, including an abstract, study description, ethical considerations, significance of the study, budget, and description of investigators 2
  • Operations Manual: not directly mentioned in the provided studies, but implied as necessary for standardized research
  • SOPs (Standard Operating Procedures): also not directly mentioned, but essential for ensuring consistency in research methods

Other Documents

Other documents, such as:

  • Contract: not directly relevant to ensuring a standardized research study
  • Calendar of Events: not mentioned in the provided studies as essential for standardized research

Correct Option

Based on the provided evidence, the correct option is:

  • A. Research Protocol, Operations Manual, and SOPs, as these documents are essential for ensuring a research study is conducted in a standardized manner 2

References

1
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

2
Research

Getting started in research: the research protocol.

The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2004

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This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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