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Recapture of Day 1
Suchart Chongprasert, Ph.D.
Food and Drug Administration
“Practical Aspects in Performing Clinical and Bioanalytical Parts in BA/BE Studies”
27-28 July 2006, Amari Airport Hotel
Source: D. O’Shaughnessy, GCP Audit/Inspection, Sept
3-4, 2001
Ethical and Regulatory Considerations
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importance of the review and approval / favorable opinion for the
protocol proposed
roles and responsibilities of the IEB/IEC
 safeguard rights, safety, and well-being
 conduct review and continuing review of a protocol
 ensuring compliance with the GCP, regulatory requirements etc.
ethical principles: Declaration of Helsinki, Belmont Report
IRB review process and criteria
Placebo controlled trial?
Informed Consent
 documents
 continuous dynamic process
Document: comprehensible, lay language, not too long, translated
version
Staff Training and Qualification
Documentation
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Qualification: education, training, and experiences
Put in updated CV periodically
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Professional education
Research Experiences
Training Requirements: Protocol/Investigator’s
brochure/GCP/local regulations/reporting
requirements
Training source: Academic/Commercial/in-house
Sponsor/international Conference
Investigational Drug Handling and Sample
Retention
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Definition according to ICH: drug, human investigation
Investigational product: manufactured, stored and used
according to cGMP standard
Define roles of sponsor relating to investigational product:
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Safety and efficacy data: Investigator’s Brochure/Product
Informational Leaflet
Details of investigational products: stability, acceptable conditions
for storage etc.
Define some experimental terms:
Blinding/Randomization/Breaking Blind
Retention of Samples: condition for storage, re use of the
sample, how long, destruction after completion of the trial
Source Data And Source Documents
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Data all information of clinical findings,
observation, or other activities in a clinical trial
Source data are contained in the source documents
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Original record
Certified copied of original records
Source documents: hospital record, result of blood
chemistry test, X-ray, microfilm, subject’s file
laboratory notes etc.
Electronic source data
Sample
Source Data
Source
Document
Changes to data
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Data to be consistent with source and
traceable to it at all times or difference
to be explained in documentation.
Subject records
CRF
Database
Paper Audit Trail
Example:
Name of patient: Yung Ah Moi Yang Ah Moi
initial
date when changed
reason for change
(by person who made the change)
CRF Completion and Medical Review
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Source data/documents
CRF Completion
Clarification of CRF
and Collection of CRF
Data reported on the CRF, that are derived from
source documents, should be consistent with the
source documents or the discrepancies should be
explained
Data entry on CRF: clear, legible, understandable
language, correction signed, dated, and reasoned
Term and coding of term
Data Handling Process I
(At the Site)
CRF Collection
Source Data
CRF Completion
Clarification of CRF
Source Data Verification
Note: Investigators have direct responsibilities for processes highlighted
Safety Reporting and Management
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Safety profile developed upon stage of non clinical
and clinical development and actual clinical
experiences after marketing
Definition and classification of AE: severity,
relationship, Expectations, Seriousness
Serious ADR, AE
Expedited report of AE: investigator’s, sponsor’s
responsibility
Monitoring, Auditing, Inspecting
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Definition
Monitoring: Sponsor’s responsibility, quality control for the
conduct of trials
Monitor: appointed by sponsor, overseeing the progress of
the trial, and ensuring that it is conducted, recorded,
reported according to SOP, GCP, applicable regulatory
requirements
CRF/Source Data Verification
Audit: definition, types of audits
Inspection: definition, reason for inspecting, level,
classification of findings
Archiving
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Considerations: locations, accessibility, volume, charge,
security, form of storage, hazards
Why, by whom, what documents, how long, where, types
Investigators and sponsors required to archive all trial
related documents and ensure they are not lost or
permanently destroy
Essential documents: IB, protocol, signed informed
consent, advertisement for recruitment, source documents,
legal and financing agreements, insurance certificate, Cv,
CRF, drug accountability records, IRB approval records