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