responsibility of an investigator


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responsibility of an investigator

  2. 2. OVERVIEW OF CLINICAL TRIAL Research studies involving patients or populations at risk for disease. Designed in a scientific manner and conform to ethical standards. May be directed at questions of causation, prevention, early detection or treatment.
  3. 3. IMPORTANCES OF CLINICAL TRIALTo increase knowledge.To provide “evidence-based” patient care orprevention of disease.To improve the quality of care.Quality care to in trial as well as out patients,(i.e.Supportive care)
  4. 4. MEMBERS OF RESEARCH TEAM Principal Investigator Regulatory Co and Bodies. Associate Investigator Institutional Clinical Review Board Research {IRB} Coordinator Data Manager Patients and Clinical Pharmacist Statistician
  5. 5. InvestigatorAn investigator -a person who is responsible forconducting clinical trial at the trail site.If a trial is conducted by a team of individuals ,then the investigator is the responsible leader ofthe team and called the principal investigator.
  6. 6. RESPONSIBILITY OF AN INVESTIGATORInvestigator should qualified ,educated, trained, experienced.Show all the up-to-date document to IRB /IEC.Familiar with investigational products and their use.Aware and comply GCP and applied regulatory requirements.Permits:- Monitoring, Auditing ,Inspection.Make appropriate list of :- Qualified persons to whom he has delegatedsignificant trial related duties.
  7. 7. RESPONSIBILITY OF AN INVESTIGATOR Adequate Resources To ensure that all the person who To arrangeassisting with the adequate Having sufficient He should recruittrial are informed numbers of time to conduct required number about “protocol, qualified staff and and complete the and suitable investigational facilities for the trial. subject. product and trial trial.related duties and functions”.
  8. 8. RESPONSIBILITY OF AN INVESTIGATOR Medical care of trial subject :-Responsible for all trial related medical decision.Ensure that adequate medical care will provided for any ADRs during trial.Informed the subjects about all the risk and health problem which canoccurred during the trial before they join the trial.If subject having some primary physician and he want to inform them, itsinvestigators duty to inform them.
  9. 9. RESPONSIBILITY OF AN INVESTIGATOR IRB/IEC Approval:- IRB/IEC Be familiar with any Drug Humanapproval of national law approval Inform any tissues protocol that may and deviation Funding (storage, and impact importation from the policies and use, transfer informed study design approved to another consent of drug the rules. or institution before {where, protocol. or otherinitiation of Participatio- how, cost}. country). study. n.
  10. 10. RESPONSIBILITY OF AN INVESTIGATOR Investigational Product Packed, labeled and It should be handled in appropriate manner. stored in correct form Include dates, The doses record quantities, batch/serial should be Correct record number, unique code maintain(quantity, numbers. date, time etc.).
  11. 11. RESPONSIBILITY OF AN INVESTIGATOR Informed consent of trial subjectObtain informed consent from patients or parents of minor patients • Prior to starting protocol. • Prior to randomizing patient if the study is a randomized trial.On going and interactive process between the research team and patient. • To ensure patient understand the study. • To ensure patient understands what is required to participate in the study.
  12. 12. RESPONSIBILITY OF AN INVESTIGATORInformation to be conveyed:-Participation is voluntary.Information about the patient’s disease.Rationale for specific therapy planned in trial.Description of the “research” objectives.Differentiation between “research elements” and “standard care”.Subjects “required involvement”:- Duration of participation. Frequency of hospitalization, out patient visits during trial. Frequency of visits after trial.Alternative approaches to treatment ( standard treatment, no treatment if noalternatives).Risk or discomforts (side effects of treatment and procedures).
  13. 13. RESPONSIBILITY OF AN INVESTIGATORState how subject confidentiality will be maintained. • Provisions for research related injuries and compensation for disability or death.Cost to the patient as a result of participation. • Contact details for problems or questions- 1.Investigator,2.Patient advocate.Notify IRB/Sponsor of any issues that pose a threat to the safety and well beingof the subject.Submit any change (amendments)made to the protocol to the IRB for approval.Provide information about protocol progress to the IRB on an annual basis(Annual continuing reviews).
  14. 14. RESPONSIBILITY OF AN INVESTIGATOR Quality and accuracy of the data recorded on study case report forms. Comply with all procedure specified in protocol in accordance with GCP. Make data available for external monitors(ifRecords and applicable). Reports:- Record all data pertinent to the study. Perform data verification,(match case report forms with source data) . Maintain all study documentation.
  15. 15. RESPONSIBILITY OF AN INVESTIGATOR Provide all required report to Sponsor, IRB/IEC andCompletion of the trial heshould inform institution the Regulatory authorities, FINAL REPORT with the summery of the trial.
  16. 16. Conclusions right, safety and well-being of subjects are PROTECTED. Data is ACCURATE. Reported results are CREDIBLE PI should strive to meet the high standards of GCP in order to provide public assurance that the:- The Principal Investigator(PI) is ultimately accountable and responsible for conducting a clinical trial. A “Research team” approach is ideal Clinical trials imply a disciplined approach to the care of the patients enrolled on the studies.