Session III: (Breakout A) - Nuts and Bolts of Clinical Trials Participation for Investigators and Sub-Investigators Clinical Research Documentation and Review Tuesday, February 2, 2010 Lindsey J. Klane. Objectives. GCP And Training Requirements (GCP, GMP And GLP) Role And Responsibilities
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Session III: (Breakout A) - Nuts and Bolts of Clinical Trials Participation for Investigators and Sub-Investigators Clinical Research Documentation and Review Tuesday, February 2, 2010 Lindsey J. Klane
… an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well being of trial subjects are protected….
The guidance was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO).
April 2006 CFR & ICH Guidelines
Prepare the IB (Investigational Brochure)
Design medically & scientifically sound clinical protocols
Obtain regulatory approvals
Select clinical investigators (CRO)
Supply the investigators with all the necessary technical & safety data to treat patients
Define the compensation to the investigator & subjects (if applicable)
Manage proper monitoring & quality assurance procedures
Handle and manage adverse events
Process clinical data (Outsource)
Prepare and report safety findings
Prepare clinical study reports
Establish & maintain company SOPs
Establish and maintain IRB SOPs
Review protocol within reasonable time; document in writing its views, identify trial/documents reviewed and dates of review
Consider qualifications of the PI proposed for the study
Conduct continuing review of ongoing trials at least once per year
Review of Informed Consent form (often request additions or deletions of text)
No coercion for subjects to participate
Review amount of payment (PI and subject
Where prior consent of a subject/legally acceptable representative is notpossible (e.g., emergency situations), determine that the protocol/other documents address ethical concerns & meet regulatory requirements
Ensure that method of subject’s compensation is included in ICF; payment must be pro-rated
Ensure additional safeguards are included in the study to protect the rights/welfare of vulnerable subjects
(children, prisoners, pregnant women, handicapped, economically/educationally disadvantaged persons)
Ref: ICH 3.1.9; FDA 21 CFR 56.111
Definition: (ICH 1.52)
Each site is responsible for maintaining the Site Regulatory Binder in accordance with local regulations.
The Central Imaging Binder will contain study specific documents for sites to acquire study compliant imaging and properly transfer images to central lab.
The Subject Binder will contain study specific documents for subjects in accordance with local regulations. Where applicable, the following documents should be filed in this binder: