Resources related to Standard Practice Guidelines (SPGs)

• Implementation Science Network Career Toolkit

  The Implementation Science Network (ISN) Toolkit outlines resources for investigators interested in pursuing implementation science research, with an eye towards building capacity for implementation science across U-M and beyond that also bridges community-based and health equity research to inform successful competitive research funding with the goal of reducing health disparities.

• Standard Practice Guidelines 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.

• Screening and Enrollment of Subjects Standard Practice Guideline

  It is essential for research teams to understand the importance of appropriately recruiting, screening, and enrolling study subjects for clinical trial research.

• Research Staff Training Standard Practice Guideline

  It is the investigator’s responsibility to ensure that all research personnel are trained appropriately and in a timely manner for all aspects of the clinical trial for which they are accountable.

• Protocol Development, Finalization, and Maintenance Standard Practice Guideline

  Thoughtful and careful review of the clinical trial protocol during the development stage is paramount. To ensure the protocol is evaluated for safety, feasibility, and scientific merit, a cross-functional team review and approval process should be implemented. Review should take place when the protocol is initially written as well as for any revisions that may subsequently occur.

• Principal Investigator (PI) Oversight / Staff Roles and Responsibilities Standard Practice Guideline

  Documentation of staff roles and responsibilities, as well as their qualifications is required in order to verify the safe and appropriate conduct of clinical research.

• Obtaining and Documenting Informed Consent/Assent Standard Practice Guideline

  Research teams must recognize and understand their roles and responsibilities for all aspects of the consent and/or assent (if required) process.

• Noncompliance in Clinical Trials Standard Practice Guideline

  The principal investigator should ensure that procedures are in place to document, communicate, and report (as required by institutional, state, and regulatory requirements) non-compliance that involves clinical trial subjects, the research team, sponsors, and clinical trial monitors especially as it relates to the safety and protection of subjects.

• Monitoring and Audit Visits Standard Practice Guidelines

  Investigators are responsible for ongoing oversight of clinical trials for adherence to the protocol and compliance with regulatory obligations. This may include monitoring the progress and quality of the trial. In addition, a clinical research site may be audited by the University of Michigan, the clinical trial sponsor or a regulatory agency.

• Medical Equipment and Instrument Use and Maintenance Standard Practice Guideline

  The purpose of the Medical Equipment and Instrument Use and Maintenance SPG is to provide a process that will ensure safe and reliable function of the equipment and accurate measurement of the research parameters being evaluated

• Management and Reporting of Adverse Events (AE), Serious Adverse Events (SAE), Unanticipated Adverse Device Effects (UADE), and Unanticipated Problems (UaP) Standard Practice Guideline

  Management and reporting of Serious Adverse Events and other reportable occurrences are an important and critical part of ensuring subject safety. Any adverse effects of a clinical trial, whether thought to be attributable to the research or not, should be documented in the subject’s study records and reported per local and federal regulatory guidelines.

• Investigational Product (IP) Standard Practice Guidelines

  The management of an Investigational Product (IP) is a complex and highly regulated activity. The IP may be a drug, biologic, medical device, or combination product; each of which may have unique regulatory and accountability requirements. If the investigator is also serving as the sponsor, additional regulations must also be taken into consideration as part of the oversight process.

• Internal Quality Assurance Process Standard Practice Guideline

  At U-M, research studies routinely undergo not-for-cause reviews by the Office of Research Compliance Review (ORCR). Not-for-cause audits are conducted to verify the research is being conducted appropriately, and recommends process improvements when necessary. ORCR's mission is to facilitate safe, ethical, efficient, and high quality research.

• Institutional Review Board (IRB) Submissions Standard Practice Guideline

  Research teams should document which members of their team will be responsible for managing U-M Institutional Review Board Medical School (IRBMED) applications in eResearch or other regulatory management systems.

• FDA Inspections Standard Practice Guideline

  It is important for research teams at all participating sites to be prepared in the event of an inspection by the Food and Drug Administration (FDA). This guidance document will help you prepare.

• Development, Implementation, and Maintenance of Standard Practice Guidelines

  The purpose of this Standard Practice Guideline (SPG) is to establish a process for the preparation, review, implementation, and retirement of an SPG.

• Data Collection Standard Practice Guidelines

  It is critical that data used for research purposes is collected in a manner which allows it to be traced back to its original source.

• Archiving Standard Practice Guideline

  The purpose of the Archiving SPG is to document a process for long-term storage of all clinical research related records.