Excellence in Research
For Faculty and Staff
Our department has a large and diverse scientific portfolio, and our research is accelerating and expanding each day. We are committed to ensuring that our investigators have adopted Good Clinical Practice (GCP) guidelines in clinical research.
Excellence in research is predicated on outstanding science and adherence to ethical, professional, and regulatory standards associated with the conduct of studies.
We will be transitioning to GCP guideline-adapted and tailored practices in our behavioral research. GCP standards are international standards that apply to all aspects of clinical trials, including design, conduct, performance, monitoring, auditing, recording, analyses, reporting, and protections of human study volunteers. Toward the goal of supporting our faculty in engaging and learning about GCP expectations, the Department will be scheduling a series of educational programs, activities, and professional development "boot camps" regarding GCP and related issues for our faculty and staff. We also will be distributing a series of communications, which we ask that you review carefully and share with staff and trainees.
We thank you in advance for your dedication to excellence in research, and we look forward to seeing you at upcoming educational events and bootcamps. -- Laura Roberts, MD, Chairman
June 2, 2017
In this webinar we’ll cover how to use the CONSORT model in your clinical research and the pragmatics of how you can do this as you collect your data. We’ll cover what a CONSORT diagram is and why it’s the standard for clinical trials in addition to practical implementation. This is an introduction to CONSORT so we can have future webinars if we find we want to gain more knowledge.
November 10, 2016
Preparing a Study Manual of Procedures (MoP)
The importance of this research tool cannot be understated. While the name varies – clinical operations protocol, manual of operating procedures, manual of operations, functional protocol – the purpose of this tool is detail how to operationalize the scientific protocol and conduct all study-specific procedures. It is an essential tool that ensures accuracy and consistency in study implementation across different study sites and research staff over time. The MoP is also an important tool for the initial training of study staff and an invaluable reference when staff turnover occurs. In this workshop, we’ll review what types of information should be included in the manual and how to use it effectively to prevent protocol drift and ensure that, to the best of our abilities, research procedures are conducted in the same manner for each study participant.
May 6, 2016
Bootcamp: Introduction to GCP Adaptations for Behavioral Research
Join us and participate in guided discussion about how we will tailor GCP standards as they will be applied to the different kinds of behavioral research being performed in the department.
- Psychiatry Best Research Practices Wiki Resources
- Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
- NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
- HRPP Policy Manual
Stanford University's Human Research Protection Program/Research Compliance Office Policies
- Research Policy Handbook
The Research Policy Handbook is a collection of policies, guidelines and general information related to the research enterprise at Stanford.
- ICH HARMONISED TRIPARTITE GUIDELINE: GUIDELINE FOR GOOD CLINICAL PRACTICE: E6(R1) and Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.