Roles and Responsibilities of Investigator

 

INVESTIGATOR

DEFINITION

An Investigator is a person responsible for the conduct of a clinical trial at a trial site.
If the trial is conducted by a team of individuals at the site, the investigator is the leader of the team and is called the Principal Investigator (PI).

REGULATORY BASIS

According to Food and Drug Administration regulations (21 CFR 312), Indian GCP Guidelines, and International Council for Harmonisation-GCP, sponsors must select appropriately trained, qualified, and experienced investigators.

ROLES AND RESPONSIBILITIES OF AN INVESTIGATOR

1. INITIATING A CLINICAL TRIAL

a) Contracts and Agreements

• Enter into all clinical trial–related agreements (clinical trial agreement, budget, confidentiality agreements).
• Ensure agreements comply with applicable regulatory and ethical requirements.

b) IEC / IRB / EC Approval

• Obtain approval from IEC/IRB/EC before initiating the trial.
• Ensure subject enrollment begins only after written approval.

c) Constituting the Study Team

• Select and supervise:
• Co-investigators
• Clinical Research Coordinator (CRC)
• Study nurse
• Pharmacist (if applicable)
• Ensure all team members are qualified and trained.

d) Planning and Ensuring Resources

• Ensure availability of:

Adequate infrastructure and facilities

• Qualified staff
• Time commitment
• Equipment and trial supplies
• Assess feasibility of conducting the trial at the site.

e) Trial Training

• Attend investigator meetings and protocol training.
• Ensure the study team is adequately trained on:
• Protocol
• SOPs
• Safety reporting
• GCP requirements

2. CONDUCT OF THE TRIAL

• Recruit eligible subjects according to the protocol.
• Obtain freely given informed consent before any trial-related procedure.
• Provide appropriate medical care to trial subjects.
• Ensure strict protocol compliance and adherence to the schedule of events.
• Comply with ICH-GCP and applicable regulatory requirements.
• Maintain proper investigational product (IP) storage, handling, dispensing, and accountability.
• Follow approved randomization and blinding/unblinding procedures.
• Communicate with:
• IEC/IRB/EC
• Sponsor and CRO
• Facilitate:
• Data collection
• Monitoring visits
• Audits and inspections
• Document:
• Protocol deviations
• Violations
• Non-compliance
• Ensure subject confidentiality at all times.
• Maintain financial records and trial-related payments.

3. SITE CLOSURE RESPONSIBILITIES

• Submit final study report to IEC/IRB/EC.
• Provide all required documents and data to the sponsor.
• Return unused investigational product and trial equipment.
• Reconcile grants and financial records.
• Archive essential trial documents for the period specified in:
• Regulations
• Sponsor agreement
• Manage premature termination or suspension of the trial, if applicable, and notify all stakeholders.

 

 

Roles and Responsibilities of Sponsor

 

ROLE AND RESPONSIBILITIES OF CLINICAL TRIAL PERSONNEL

(As per ICH-GCP)

DEFINITION: SPONSOR

Sponsor
A sponsor is an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial, as defined under International Council for Harmonisation-GCP, Food and Drug Administration regulations, and Indian GCP.

ROLES AND RESPONSIBILITIES OF THE SPONSOR

1. Selection of Investigator and Institution/Hospital

• Select qualified, trained, and experienced investigators.
• Ensure institutions/hospitals have adequate infrastructure, staff, and facilities.
• Provide:
• Approved protocol
• Investigator’s Brochure (IB) (current version)
• Confirm investigator’s ability to comply with protocol and GCP.

2. Contracts / Agreements

• Enter into written agreements with investigators and institutions.
• Agreements must clearly define:
• Trial conduct according to approved protocol and IEC approval
• Compliance with sponsor Standard Operating Procedures (SOPs)
• Sponsor’s right to monitor, audit, and inspect
• Financial arrangements and compensation
• Protocol must be signed by both sponsor and investigator as confirmation.

3. Allocation of Duties and Functions

• Identify, define, and allocate all trial-related duties.
• Ensure responsibilities are assigned to qualified personnel.
• Maintain documentation of delegation and oversight.
• Ultimate responsibility always remains with the sponsor, even if duties are delegated.

4. Clinical Trial Management, Data Collection, Handling & Record Keeping

• Continuously review trial progress, including:
• Safety data
• Efficacy endpoints
• Decide whether to continue, modify, or terminate the trial.
• When using electronic data systems, ensure:
• Written SOPs
• Audit trails
• Data security and restricted access
• Adequate backup and data recovery
• Maintain confidentiality of trial data.
• Retain essential sponsor documents as per regulatory timelines.

5. Compensation to Subjects and Investigators

• Ensure compensation for:
• Trial-related injury or death (subjects)
• Investigator payments as per agreement
• Payments must not influence trial conduct or subject safety.

6. Ethics Committee (IEC/IRB) Review Confirmation

• Ensure IEC/IRB approval before trial initiation.
• Obtain and maintain documentation of:
• Initial approval
• Continuing review
• Amendments and protocol deviations

7. Information on Investigational Product (IP)

• Provide sufficient non-clinical and clinical data on IP.
• Ensure information supports safe and proper use of the product.

8. Manufacturing, Packaging, Labeling & Coding of IP

• Ensure IP is manufactured according to GMP.
• Labeling must comply with regulatory requirements.
• Coding systems must allow blinding and emergency unblinding.

9. Supply and Handling of Investigational Product

• Ensure proper:
• Storage
• Distribution
• Accountability
• Maintain records of:
• Shipment
• Dispensing
• Return/destruction

10. Safety Information

• Continuously evaluate safety data.
• Ensure investigators are promptly informed of new safety findings.
• Update Investigator’s Brochure when required.

11. ADR / SAE Reporting

• Ensure timely reporting of:
• Serious Adverse Events (SAEs)
• Suspected Unexpected Serious Adverse Reactions (SUSARs)
• Comply with regulatory timelines and reporting formats.

12. Contract Research Organization (CRO) Management

• Sponsor may transfer duties to a CRO.
• Must:
• Clearly document delegated responsibilities
• Maintain oversight and accountability
• Legal responsibility cannot be transferred.

13. Record Access

• Allow regulatory authorities, IEC, and auditors direct access to trial-related records.
• Ensure subject confidentiality is maintained.

14. Monitoring

• Implement a monitoring plan.
• Ensure:
• Subject safety
• Data accuracy and completeness
• Protocol and GCP compliance

15. Audit

• Conduct independent audits when required.
• Ensure audit findings are documented and corrective actions implemented.

16. Premature Termination or Suspension

• May terminate/suspend trial for:
• Safety concerns
• Lack of efficacy
• Administrative or regulatory reasons
• Notify:
• Investigators
• IEC
• Regulatory authorities
• Provide written explanation.

17. Clinical Trial / Study Reports

• Prepare comprehensive clinical study reports.
• Reports must be accurate, complete, and verifiable.

18. Multicenter Trials

• Ensure:
• Standardized protocol implementation
• Consistent data collection across sites
• Coordinated monitoring and reporting