Investigator

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

Topics Include:

• Researcher Responsibilities
• Ethical Research Principles
• GCP Training

Researcher Responsibilities:

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

• Sign and date a CV.
• Institutional Review Board/ Independent Ethics Committee (IRB/IEC)
• Provide Abbott Diagnostics with IRB/IEC Continuing Review documents.
• Upload IRB/IEC approval letter, IRB/IEC approved protocol, IRB/IEC approved informed consent (ICF), and IRB/IEC approved subject material.
• Sign a 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 Diagnostics throughout the study. Abstracts, Posters, Manuscripts must be reviewed with Abbott prior to submission.

Click on the following links to review US, EU, Asia-Pacific Region guidelines and responsibilities of those conducting research. Check other local policies that are available and may apply.

• EU:
  https://ec.europa.eu/growth/sectors/medical-devices/guidance_en
  http://ec.europa.eu/DocsRoom/documents/17522/attachments/1/translations/
• Singapore:
  http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Clinical_Trials/Overview/Regulatory_Guidelines.html
• Malaysia
  http://npra.moh.gov.my/en/index.php/guidelines-central
• Philippines
  https://ww2.fda.gov.ph/196-list-of-laboratories-recognized-by-the-fda/343801-clinical-trial-requirements
• Indonesia
  http://www.pom.go.id/new/files/CUKB_04.pdf
• India:
  http://www.cdsco.nic.in/writereaddata/CDSCO-GuidanceForIndustry.pdf
  http://cdsco.nic.in/html/D&C_Rules_Schedule_Y.pdf
  https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm125125.pdf
  http://www.icmr.nic.in/ethical_guidelines.pdf
  http://cdsco.nic.in/html/GCP1.html
• FDA Information Sheets (US FDA)
• Informed Consent Process (US FDA)
• HIPAA Privacy Rule Information for Researchers (US DHHS)
• Subject Recruitment (US FDA)
• Awareness of state and local research laws (US FDA)

Ethical Research Principles

• Belmont Report
  The Belmont Report is the “Ethical Principles and Guidelines for the Protection of Human Subjects of Research”. Finalized on April 18, 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, this document identifies three primary ethical principles: Respect for Persons, Beneficence, and Justice.
• Declaration of Helsinki
  The Declaration of Helsinki is a statement of ethical principles for medical research involving human subjects. The document was adopted in June 1964 by the 18th World Medical Association General Assembly in Helsinki, Finland.
• Nuremburg Code
  The Nuremburg Code identifies Directive for Human Experimentation. This code was resulting from the Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law. This judgment estabished a new standard of ethical medical behavior for the post World War II human rights era. Among other requirements, this document vocalizes the requirement of voluntary informed consent of the human subject. The principle of voluntary informed consent protects the right of the individual to control his own body.

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.”