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103 Principal Investigator Responsibilities for Sponsored Trials

Document Name:
Principal Investigator Responsibilities for Sponsored Trials		Document Number:
103		Revision Date:
21JUN2024		Supersedes:
103.00
Target Group:
Research Personnel		Approval Date:
20Dec2024		Effective Date:
01Jan2025		Training Required:
-Human Subjects Protection (HSP)
-Good Clinical Practice (GCP) 

Purpose

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.

This Standard Operating Procedure (SOP) describes the procedure and methods for selecting, qualifying, and training Principal Investigators (PIs). It also lists their responsibilities for conducting sponsored clinical studies with the CTRU.

Responsibilities

The CTRU is responsible for developing, implementing, and maintaining SOPs. Changes to federal regulations, guidelines, institutional policies, or procedures determine whether an SOP should be created or revised. Departments and research teams conducting human subject research will receive all applicable documents.

Definitions

Principal Investigator: A Principal Investigator is an individual, D.O., M.D. or equivalent (Ph.D., Pharm. D. etc.) who conducts a clinical study under whose immediate direction the drug/device/intervention under investigation is administered. When a team of individuals investigates, the leader of the team responsible is the PI.

Procedures

1. Investigator Selection Procedures:

  • The protocol submitted by the PI must be reviewed and approved by the Clinical and Translational Research Unit (CTRU) leadership for safety and feasibility.
  • The site must have qualified study personnel with sufficient time, knowledge, and experience to conduct the study.
  • The site must have adequate facilities and proper equipment to conduct the study. 
  • The site must have access to an adequate number of potential study subjects who meet the study criteria.
  • The PI must be qualified to study the population area described in the protocol and trained in research methodology. The PI must understand the investigational nature of the study and all associated requirements.
  • The PI must not be listed on the FDA's "Investigators Ineligible to Receive Investigational New Drugs" list.
  • The site must agree to allow a coordinator to provide oversight of study details and ensure cooperation of the site staff.
  • A site visit may be conducted to evaluate the PI and study site facilities. The purpose of the visit is to assess the potential of the study site and the PI for clinical studies and to determine the PI's interest in conducting the study.
  • Should a site visit occur, the following items will be reviewed and/or documented:
    • Name, address, credentials (if possible, obtain a copy of the CV).
    • Names and credentials of study personnel.
    • Previous experience with clinical studies.
    • Type and size of the patient population.
    • Number of clinical studies the site can handle at one time and how many will be ongoing when this trial is active.
    • Qualifications and quantity of staff available for the conduct of this study. Ensure the site has adequate and complete facilities and proper equipment.
    • Whether the site has been inspected by the FDA, and if so, the outcome.
    • Name of the IRB (if different from the PI), frequency of meetings, and whether the IRB is qualified.
    • PI agrees to obtain IRB approval and study subject informed consent before starting the study.
    • If available, review the potential protocol and the ability of the PI to conduct it.
    • Expected dates of the study.
    • Agreement with the PI to adhere to the protocol and comply with the responsibilities listed under federal regulations, Good Clinical Practice (GCP) guidelines, and CTRU SOPs.
    • Inspection of laboratory facilities, copy of the license, and normal values. Inspection of the pharmacy and personnel to assess qualifications, drug/device storage facilities, and methods of recording drug/device disposition.
    • Inspection of laboratory facilities, copy of the license, and normal values. Inspection of the pharmacy and personnel to assess qualifications, drug/device storage facilities, and methods of recording drug/device disposition.
  • After the site visit, a site visit report documenting the findings is written and filed in the investigator's file at the site. If the PI meets the criteria and has the proper facilities, staff, and potential study subject population, they may be selected as an investigator.

2. Investigator Responsibilities:

  • Sign FDA Form 1572 (if applicable), agreeing to adhere to Federal regulations and guidelines.
  • Obtain IRB approval for the protocol, advertisements, and informed consent before initiating the study.
  • Read and understand the information provided on the drug/device/intervention.
  • Ensure all personnel involved in the study are informed of their study obligations.
  • Conduct clinical study according to FDA regulations and guidelines.
  • Obtain proper written informed consent from each study subject prior to participation in the study.
  • Adhere to the Sponsor's protocol.
  • Maintain the well-being and safety of the study subjects.
  • Be responsible for the overall conduct of the study.
  • Notify the IRB of study changes, provide at least annual progress reports, and prepare a final study report.
  • Report serious adverse events promptly to the IRB and Sponsor.
  • Maintain adequate and accurate case histories for each study subject, recording all observations and data during the study.
  • Maintain accurate and complete records of the receipt, dispensing, and return of all clinical supplies, noting and explaining any discrepancies.
  • Retain all study records for the required period, per the Ohio University IRB records retention policy following study close-out, or for 2 years from the time the New Drug Application (NDA) is approved, or according to Sponsor requirements, whichever is longer.
  • Permit FDA and Sponsor representatives to inspect study records.
  • Comply with all other obligations listed in Federal Regulations Part 312 for investigators.

3. Training of investigators:

  • Investigators will attend the Sponsor's investigators meeting, when required, to become informed regarding the study drug/device/intervention and study responsibilities.
  • Each investigator will attend a protocol-specific meeting with the investigator site staff to review investigator responsibilities and to become fully informed on the details of the protocol and their responsibilities in performing it.
  • If recommended, each investigator will attend a course on Clinical Investigator responsibilities.

Applicable Regulations, Guidance, and Policies

RegulationTitle
21 CFR 50Protection of Human Subjects
21 CFR 312Investigational New Drug Application 
21 CFR 812Investigational Device Exemptions 
45 CFR 46Protection of Human Subjects
ICH E6(R2)Guideline for Good Clinical Practice E6 Integrated Addendum
FDA Guidance for IndustryInvestigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects, October 2009 

References: None

Attachments: None

Appendices: None

Approver: Director, CTRU and Clinical Partnerships