Standard Practice Guideline (SPG) Templates for Clinical Trials

Overview

These Standard Practice Guidelines (SPGs) are designed to provide the framework for managing a core set of activities associated with the conduct of clinical trials.

In the management of clinical trials, it is critical to define and adhere to process standards that are consistent with institutional, state, federal, and international policies and regulatory requirements. The guidelines may be applied at the research team, department, or organization level to document regular work processes.

Documentation of standard practices (i.e. Standard Operating Procedures (SOPs), Quality Assurance Procedures, Best Practice Guidelines etc.)  is required for sponsors when conducting clinical trials that follow International Conference on Harmonisation Good Clinical Practice (ICH GCP), and are used to help researchers promote consistency, quality, and ensure compliance with University of Michigan policies and governmental regulations. Although the material presented is geared toward clinical trials, the value of utilizing standard practices and following ICH GCP applies to all types of clinical research.

Keep in mind that SPGs used for clinical trials that require regulatory compliance (i.e. FDA and/or ICH GCP) are treated differently than best practice or guidance documents. SPGs for these types of clinical trials are auditable by relevant internal as well as external entities and regulatory bodies. The FDA, OHRP, and the IRB will hold the study team to the SPGs they create and will find non-compliance if they fail to follow the documented written procedures. Therefore, SPGs should be written in a manner that provides a reasonable level of detail while still allowing for acceptable and expected variations in how the work is routinely performed. To ensure SPGs are followed, remember to:

1. Store SPGs in a centralized location that allows for ease of access for all study team members.

2. Adopt a version control process so the most current, approved version of an SPG is used.

Standard Practice Guideline (SPG) Templates

The Standard Practice Guideline templates below provide a core set of standard, high-level guidance documents that can be utilized by University of Michigan researchers when conducting clinical trials. These documents can be customized by research teams to address specific study team, department, or organization requirements. The template content was provided by clinical research subject matter experts.

Note: These SPGs should not be confused with the University’s Standard Practice Guide which is approved by university leadership and applies to the entire institution.  

The University Standard Practice Guide applies to the whole institution, but every campus, school, college, and department has unique needs and operations. Individual units may develop policies and procedures to suit their circumstances, provided they remain consistent with SPG requirements and external legal obligations. 

University Standard Practice Guide: http://spg.umich.edu/about/about-this-website

The SPG templates are intended for research teams conducting clinical trials in academic institutions. They may not be used for commercial purposes. 

Downloadable Templates and Appendices

Development, Implementation, and Maintenance of Standard Practice Guidelines

SPG of SPGs.docx

Appendix A SPG Format.docx

Appendix B Deviations and Waivers.docx

Appendix C Appendix Header.docx

Appendix D SPG Training Log.docx

Appendix E SPG Version History Log.docx

Archiving

Archiving.docx

Appendix A Record Disposition.docx

Data Collection

Data Collection.docx

Appendix A Document Tracking Log.docx

FDA Inspections

FDA Inspections.docx

Institutional Review Board Submissions

IRB Submissions.docx

Internal Quality Assurance Process 

Internal QA Process.docx

Investigational Product (IP)

Investigational Product.docx

Management and Reporting of Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects, and Unanticipated Problems

AE Reporting.docx

Medical Equipment and Instrument Use and Maintenance

Maintenance and Use of Equipment and Instruments.docx

Appendix A SOP Equipment Sign Out Lending Log.docx

Appendix B SOP Equipment Maintenance Log.docx

Monitoring and Audit Visits

Monitoring and Audit Visits.docx

Noncompliance in Clinical Trials

Noncompliance in Clinical Trials.docx

Obtaining and Documenting Informed Consent/Assent

Informed Consent.docx

Principal Investigator (PI) Oversight/Staff Roles and Responsibilities

PI Oversight.docx

Protocol Development, Finalization, and Maintenance

Protocol Development.docx

Appendix A Protocol Approval Form.docx

Registration and Maintenance of ClinicalTrials.gov

Under Construction

Research Staff Training

Research Staff Training.docx

Screening and Enrollment of Subjects

Screening Enrollment.docx

Downloadable ZIP File of All SPG Templates

SPGs.zip

Questions?

Contact us at MICHR-SPGSupport@umich.edu.

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