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Good Clinical Practice

A lab worker conducts research

Good Clinical Practice (GCP) is an international, ethical, and scientific quality standard for designing, conducting, recording and reporting research involving human subjects. GCP guidelines define the roles and responsibilities of the IRB, investigator and sponsor throughout the clinical trial and also describe the essential documents needed for the conduct of a clinical trial. Compliance with GCP ensures that the rights, safety and welfare of subjects is protected and that the data produced by the research is credible.

These guidelines have been adopted into law in several countries and have been endorsed by the FDA ( since 1997) as an international quality standard that serves as a guidance for practice and regulation in the Unites States. Compliance with these guidelines in both institutional and industry is expected when conducting human research.

There are 13 principles within GCP. These are as follows:

  • Ethical Conduct of the research activity is foremost
  • Benefits justify Risks in all aspects of the human research
  • Rights, Safety and Well-being of subjects prevails
  • Nonclinical and clinical information is relevant to the trial
  • Adherence and compliance with an approved scientifically sound protocol is necessary
  • IRB approval is required prior to initiation of any research related activities
  • Medical care decisions are made by a qualified physician
  • Study activities are appropriately delegated to designated and qualified study personnel based upon experience and expertise
  • Informed consent is freely given prior to participation
  • Data is accurately reported, interpreted and verified
  • Confidentiality of data and privacy of person is protected
  • The use of investigational products always conforms to Good Manufacturing Practice
  • Systems and procedures are in place to ensure quality of research on all levels

In order to comply with these guidelines, it is essential that researchers receive GCP training and submit documentation of successful completion of training to the Trinity Health Regional Institutional Review Board during the protocol application process. Applications that do not include this documentation will not be accepted. Please refer to Education and Training for additional training links and requirements.

Trinity Health Office of Research & Innovation – West Michigan is available to assist investigators with adherence to GCP, which often involves organization and documentation of study activities and involved personnel. The following GCP Document Kit includes tools and templates intended to help organize study documents, document required information, track study procedures and avoid common errors related to study management.

The listed tools may not be applicable to every study and should be used only as applicable to the research. The goal is to utilize only those tools that are of benefit to the study and the involved staff. For further assistance with the use of the forms or a better understanding of their applicability to your research activity, please submit a consultation request.

GCP Document Kit

Delegation of Responsibility Log (PDF, 20KB) – This document will describe each study staff member's individual role and responsibilities, dates of involvement in the study, contact information and Principal Investigator oversight.

Subject Enrollment Log (PDF, 29KB) – This is used to document the progress of enrolled subjects, indicating the subject study ID number, date of consent and additional demographic details.

Subject Eligibility Criteria Checklist (PDF, 29KB) – Identifies each inclusion and exclusion criteria and provides a means to verify each has been reviewed and validated by a member of the research team and confirmed by the Principal Investigator prior to subject enrollment.

Study Visit Checklist (PDF, 33KB) – Provides a means to organize study visits and document each required assessment on a per visit basis to ensure accuracy and consistency for the duration of the subject's participation.

Monitoring Log (PDF, 70KB) – Documents all instances of study review performed by external monitors, including interim monitoring visits, site initiation visits, and regulatory audits.

Note to File Template (PDF, 86KB) – Provides a means to document discrepancies or provide clarification to conduct of the study, including study data and process and procedure.

Adverse Event Tracking Log (PDF, 33KB) – Documents patient specific adverse events that have occurred during the course of the study, including the determination of seriousness, causality in relation to investigational agent, expectedness related to prior experience and date of reporting both internally and externally as applicable.

Drug Accountability Log (PDF, 25KB) – Provides a means to document and track investigational drug dispensation, return and accountability.

Device Accountability Log (PDF, 25KB) – Provides a means to document and track investigational device dispensation, return and accountability.

Temperature Log (PDF, 111KB) – Provides a means to document the temperature of the area where investigational drug or related products are stored. If the investigational product is stored within the Clinical Trial Unit, all areas have electronic temperature monitoring where reports can be generated upon request. If the investigational product is stored elsewhere, temperature should be monitored daily using a form such as this template.

Regulatory File Checklist (PDF, 135KB) – To be used as a reference when organizing your regulatory binder. Not every document will be applicable to your project, however each section should be considered. Consult with the Office of Research & Innovation for assistance as needed.