Investigator

As the Principal Investigator (PI) of an Investigator Sponsored Study (ISS), the PI is responsible for initiating and conducting, alone or with others, the ISS with obligations of a sponsor and investigator.

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

Topics Include:

• Researcher Responsibilities
• Ethical Research Principles

Researcher Responsibilities:

If your submission is approved, you will be expected to fulfill the following responsibilities:

• Signed and dated CV
• Institutional Review Board/ Independent Ethics Committee (IRB/IEC) approval, if applicable
• IRB/IEC Continuing Review documents, if applicable.
• IRB/IEC approval letter, IRB/IEC approved protocol, IRB/IEC approved informed consent (ICF), and IRB/IEC approved subject material, as applicable
• Executed research study agreement
• Register the study with a clinical trial registry and provide the name of this registry, if applicable
• 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) to Abbott Point of Care (APOC) and local regulatory agencies, as applicable
• Maintain product accountability records for all products provided by APOC throughout the study. Abstracts, Posters, Manuscripts must be reviewed with Abbott prior to submission
• Follow any regional and local guidelines, regulations or policies that are available and may apply
• 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.

Ethical Research Principles

References:

1. Ryan KJ, Brady JV, Cooke RE, Height DI, Jonsen AR, King P et al. The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research. J Am Coll Dent. 2014 Summer; 81(3):4-13.
2. General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent. 2014 Summer; 81(3):14-8.
3. The Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2: 181-2.