Investigator

This area is to help investigators and site staff better understand the roles and responsibilities involved with conducting research studies.

• Your submission does not guarantee that your research proposal will be supported by Abbott.
• Abbott selects studies it will support based on objective qualifications and merit.
• Supported studies remain independent from Abbott and Abbott does not direct or control the research. Accordingly, as sponsor of the study, you are not considered to be performing services for Abbott. As in all scientific research, you are responsible for independently selecting study participants.

INVESTIGATOR RESPONSIBILITIES:

When you submit, you will be expected to fulfill the following responsibilities:

• Provide a comprehensive CV
• Provide research study protocol
• Institutional Review Board / Ethics Committee Letter of approval (waiver if applicable)
• Informed Consent Form Institutional Review Board / Ethics Committee Letter of approval (waiver if applicable)
• Sign study agreement
• If applicable, register the study with a clinical trial registry and provide the name of this registry.
• Throughout the study, report any changes in conduct of the study. This includes enrollment changes, subject status, IRB/IEC updates, and any other relevant information.
• Throughout the study, report any Product/Device Related Adverse Events (AEs) or to local regulatory agencies Adverse Events.
• Maintain product accountability records for all products provided by Abbott throughout the study.

Good Clinical Practice (GCP) Training

Investigators, Sponsors, and IRBs/IECs must have a working knowledge and understanding of Good Clinical Practice (GCP) in order to assure the best protection of human subjects involved in research.

Each has their own responsibility to gain knowledge of GCP and adhere to GCP guidelines during the conduct of clinical studies. GCP training may be obtained from multiple sources, below are available options for consideration:

• Collaborative IRB Training Initiative (CITI)
  CITI is a web based training program with modules for Biomedical and Social & Behavioral Research. The entire course takes 6 hours and the CITI system allows you to take the training over several sessions.
• Human Participant Protections: Education for Research Teams (NIH)
  The National Institute of Health (NIH) offers an educational program entitled “Human Participant Protections Education for Research Teams”. This tutorial presents common concepts, principles, and issues related to protection of human participants, including principles of bioethics and basic legal standards.
• Barnett International
  Barnett International is a division of Parexel. Barnett offers conferences, seminars, and also provides publications.
• Association of Clinical Research Professionals (ACRP)
  ACRP is a professional organization for the clinical research industry that offers educational conferences and seminars on an international level. The mission statement of ACRP is “The purpose of the Association is to provide global leadership for the clinical research profession by promoting and advancing the highest ethical standards and practices.”