SITES



SITES

Sites / Investigators / Researchers

Please click on the relevant link to download the support document you require. Documents are a PDF version. To ensure maximum compatibility please have the most current version of Adobe® Acrobat or equivalent installed on your computer. Should you have any questions regarding any of these forms please do not hesitate to contact us.


General Guidance: Investigator Responsibilities (Available in English & French)

The purpose of this guidance document is to provide instructions to investigators, contract research organizations (CROs) and sponsors about the investigator reporting obligations to the IRB.

Instructional Materials: Unanticipated Problems

The purpose of this document is to provide additional instructions to investigators, contract research organizations (CROs) and sponsors about unanticipated problems that need to be reported to the IRB.

Health Canada's GCP Pre-inspection Package

Health Canada's pre-inspection package which will assist Canadian research sites in complying with Health Canada regulations and preparing for an inspection by the Health Product and Food Inspectorate.

Instructional Materials: Financial Conflict of Interest

The purpose of this document is to provide additional instructions to investigators, contract research organizations (CROs) and sponsors on the disclosure and management of any conflicts of interest in order to:

A) Promote objectivity in research
B) Minimize bias in research

Who can I contact with questions or concerns?

If you are a researcher (or a member of the research team) involved in research that has been reviewed by IRB Services, you may contact us if you wish to obtain answers to questions, express concerns, or convey suggestions regarding the human research protection program.

FDA Guidance for Industry

Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects

This guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological product, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)). The goal of this guidance is to help investigators better meet their responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations. This guidance is intended to clarify for investigators and sponsors FDA’s expectations concerning the investigator’s responsibility (1) to supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or other third parties and (2) to protect the rights, safety, and welfare of study subjects.