Investigator Responsibilities

Investigator
Ensure subject safety
Develop reliable data

How investigator should be?

• Have good resource
• Understand IRB requirement
• Understand inform consent process
• Execute effective patient management
• Adhere to Protocol

Have Good Resource
Investigators’ qualification

• Education
• Training
• Experience

Investigator Qualifications

• Understand and Comply with GCP
• Familiar with study product
• Understand Study protocol

Recruitment Potential

• Subject pool
• Subject resource

Recruitment Strategy

• Study design and Timeline
• Subject Population (healthy subject or patient)
• Aware of study challenge and timeline
• Recruitment Source
• Recruitment Method
• Recruitment Material
• Recruitment Plan
• Recruitment Tracking

Recruitment Source

Have Good Resource

• Qualified staff
• Qualified facilities

Facility

• Investigator has sufficient time to conduct and complete the study
• Site staffs are adequately informed on study related information.
   

Study Product Store in accordance with protocol Use in accordance with protocol
Accountability of study product Properly maintain the record     - Delivery and return     - inventory     - Use of study product Reconciliation of study product

Understand IRB Requirement

• Provide study related doc to IRB/ERC for review and approve
      - Protocol, Inform consent, investigator’s brochure or others
• Sign protocol or alternative contract to confirm an agreement
• Ensure the written approval on protocol, inform consent and other written doc provided to subject
• Provide any updated doc for review and approval
      - Protocol, Inform consent, investigator’s brochure or others
• Progress Report
      - Submit study update to IRB/ERC accordingly
      - Promptly report to IRB/ERC if any significant change to study or increase risk to subject
• Safety Report
      - Immediately report any serious adverse event to sponsor
      - Follow IRB/ERC regulation on any of AE report
      - Use code number to identify subject
      - In case of dead, additional information such as autopsy is needed
• Final Report
      - Notify IRB/ERC upon completion
      - Providing IRB/IEC with a summary of the trial’s outcome

Understand Inform Consent Process

• Obtain IC before a subject enters the study
• Use the most understandable language to communicate
• Avoid coerce or unduly influence a subject
• No language waive or appear to waive any legal right or liability for negligence
• Provide time and opportunity to read and decide
• Answer all questions

Inform consent     - Personally signed and dated by subject or legal representative

• An impartial witness is presented through out the process of inform consent if a subject is unable to read
• An impartial witness must personally sign and date
• New information in inform consent should be informed to a subject in the timely manner after IRB/ERC review and approve

Execute Effective Subject Management

• Medical Care of Subject
      - Responsible for study related medical decisions
      - Adequate medical care is provided in the event of AE during the study
      - Inform a subject’s primary doctor of subject participation
• Premature Termination/Suspension
      - Promptly inform subject
      - Assure appropriate therapy and follow up for the subject
      - Comply with any IRB/ERC or regulatory requirement

If investigator terminates or suspends the study without prior agreement with the sponsors, must inform

• Sponsor
• IRB/IEC
• Provide written explanation to sponsor and IRB/IEC for the termination

If IRB/IEC terminates or suspends its approval

• Inform the institution

If sponsor terminates or suspends a study

• Inform IRB/IEC and Investigator
• provide explanation of the termination or suspension

Adhere to Protocol

• Randomization procedures and unblinding
      - Following protocol randomization procedure
      - Unblinding according to protocol
      - Document and notify on any premature unblinding
• Record and Report
      - Ensure accuracy, completeness, legibility and timeliness of data entered to the case report form
      - Ensure the consistency of the data
      - Ensure that any change to the data is initialed, dated and explained

Example:

Source Document	CRF

• Retain any document drop under essential document
• Prevent accidental or premature destruction of document
• Make available for monitoring , auditing or inspecting

Essential Document (ICH GCP 8)