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Role and Responsibilities of Clinical Trial Personnel

  • Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
  • Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
  • Therights, safety, and well-being of the trial subjects are the most important considerations and should prevail over the interests of science and society.
  • The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
  • Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
  • Freely given informed consent should be obtained from every subject prior to clinical trial participation.
  • All clinical trial information should be recorded, handled, and stored in a way that allows accurate reporting, interpretation, and verification.
  • Clinical trials should be scientifically sound and described in a clear, detailed protocol.
  • A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB) / independent ethics committee (IEC) approval / favorable opinion.
  • The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
  • The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
  • Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practices (GMP). They should be used in accordance with the approved protocol.
  • Systems with procedures that assure the quality of every aspect of the trial should be implemented.

Institutional Review Board/Independent Ethics Committee (IRB/IEC)
  1. Responsibilities
  2. Composition
  3. Functions
  4. Operations Procedures
  5. Records

Investigator
  1. Investigator's Qualifications and Agreements.
  2. Adequate Resources.
  3. Medical Care of Trial Subjects Communication with IRB/IEC.
  4. Compliance with Protocol.
  5. Investigational Product(s).
  6. Randomization Procedures and Unblinding.
  7. Informed Consent of Trial Subjects.
  8. Records and Reports.
  9. Progress Reports.
  10. Safety Reporting.
  11. Premature Termination or Suspension of a Trial.
  12. Final Report(s) by Investigator.

Sponsor
  1. Quality Assurance and Quality Control
  2. Contract Research Organization (CRO)
  3. Medical Expertise
  4. Trial Design
  5. Trial Management
  6. Data Handling, and
  7. Record Keeping
  8. Investigator Selection.
  9. Allocation of Responsibilities.
  10. Compensation to Subjects and Investigators. Financing
  11. Notification/Submission to Regulatory Authority(ies)
  12. Confirmation of Review by IRB/IEC.
  13. Information on Investigational Product(s).
  14. Manufacturing, Packaging, Labelling, and Coding Investigational Product(s).
  15. Supplying and Handling Investigational Product(s)
  16. Record Access Safety Information
  17. Adverse Drug Reaction Reporting

Monitoring
  1. Purpose.
  2. Selection and Qualifications of Monitors
  3. Extent and Nature of Monitoring
  4. Monitor's Responsibilities.
  5. Monitoring Procedures
  6. Monitoring Report.

Audit
  1. Purpose
  2. Selection and Qualification of Auditors
  3. Auditing Procedures
  4. Statistics.
  5. Direct Access to Source Data/Documents.
  6. Quality Control and Quality Assurance.
  7. Ethics.
  8. Data Handling and Record-Keeping.
  9. Financing and Insurance.
  10. Publication Policy.
  11. Supplements.
  12. Noncompliance
  13. Premature Termination or Suspension of a Trial
  14. Clinical Trial/Study Reports
  15. Multicentre Trials

Clinical Trial Protocol And Protocol Amendment(s)
  1. General Information.
  2. Background Information.
  3. Trial Objectives and Purpose
  4. Trial Design
  5. Selection and Withdrawal of Subjects
  6. Treatment of Subjects Assessment of Efficacy
  7. Assessment of Safety

Investigator’s Brochure
  • Introduction
  • General Considerations.
  1. Title Page.
  2. Confidentiality Statement.
  • Contents of the Investigator’s Brochure
  1. Table of Contents.
  2. Summary.
  3. Introduction; Physical, Chemical, and Pharmaceutical Properties and Formulation.
  4. Nonclinical Studies.
  5. Effects in Humans.
  6. Summary of Data and Guidance for the Investigator.

Essentia
l Documents For The Conduct Of A Clinical Trial

  • Introduction
  • Before the Clinical Phase of the Trial Commence.
  • During the Clinical Conduct of the Trial.
  • After Completion or Termination of the Trial.

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