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Investigators Responsibilities during Clinical trials Slide 1 Investigators Responsibilities during Clinical trials Slide 2 Investigators Responsibilities during Clinical trials Slide 3 Investigators Responsibilities during Clinical trials Slide 4 Investigators Responsibilities during Clinical trials Slide 5 Investigators Responsibilities during Clinical trials Slide 6 Investigators Responsibilities during Clinical trials Slide 7 Investigators Responsibilities during Clinical trials Slide 8 Investigators Responsibilities during Clinical trials Slide 9 Investigators Responsibilities during Clinical trials Slide 10 Investigators Responsibilities during Clinical trials Slide 11 Investigators Responsibilities during Clinical trials Slide 12 Investigators Responsibilities during Clinical trials Slide 13 Investigators Responsibilities during Clinical trials Slide 14 Investigators Responsibilities during Clinical trials Slide 15 Investigators Responsibilities during Clinical trials Slide 16 Investigators Responsibilities during Clinical trials Slide 17 Investigators Responsibilities during Clinical trials Slide 18 Investigators Responsibilities during Clinical trials Slide 19 Investigators Responsibilities during Clinical trials Slide 20 Investigators Responsibilities during Clinical trials Slide 21 Investigators Responsibilities during Clinical trials Slide 22 Investigators Responsibilities during Clinical trials Slide 23 Investigators Responsibilities during Clinical trials Slide 24 Investigators Responsibilities during Clinical trials Slide 25 Investigators Responsibilities during Clinical trials Slide 26 Investigators Responsibilities during Clinical trials Slide 27 Investigators Responsibilities during Clinical trials Slide 28 Investigators Responsibilities during Clinical trials Slide 29 Investigators Responsibilities during Clinical trials Slide 30 Investigators Responsibilities during Clinical trials Slide 31 Investigators Responsibilities during Clinical trials Slide 32 Investigators Responsibilities during Clinical trials Slide 33 Investigators Responsibilities during Clinical trials Slide 34 Investigators Responsibilities during Clinical trials Slide 35 Investigators Responsibilities during Clinical trials Slide 36 Investigators Responsibilities during Clinical trials Slide 37
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Investigators Responsibilities during Clinical trials

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This Presentation was presented by Pruthvi raj, Tejaswini, and myself Bhavya Rajan at Clinosol Research Pvt Ltd. We would like to thank Clinosol and Mujeeb sir for this opportunity. for constantly supporting and encouraging us

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Investigators Responsibilities during Clinical trials

  1. 1. INVESTIGATOR’S RESPONSIBILITIES Bhavya RajanM.tech Pruthvi rajPharmD TejaswiniBPharm Presented by ClinoSol research Pvt.Ltd Education and research center
  2. 2. 1. Investigator’s Qualifications and Agreements 2. Adequate Resources 3. Medical Care of Trial Subjects 4. Communication with IRB/IEC 5. Compliance with Protocol 6. Investigational Product(s) 7. Randomization Procedures and Unblinding 8. Informed Consent of Trial Subjects 9. Records and Reports 10.Progress Reports 11.Safety Reporting 12.Premature Termination or Suspension of a Trial 13.Final Report(s) by Investigator CONTENT
  3. 3. Who can be an investigator in clinical trial ? An investigator…  is a qualified physician who is responsible for all trial-related medical decisions  must have suitable education, training and experience in the field being researched and also have a knowledge of GCP and applicable regulatory requirements  should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies)  If a trial is conducted by a team of individuals at a trial site, the Investigator is the responsible leader of the team and may be called the principal Investigator.  Sub-Investigator: a member of Clinical trial team, designated and supervised by principal Investigator to perform trial related duties and functions.
  4. 4. INVESTIGATOR’S QUALIFICATIONS AND AGREEMENTS
  5. 5. INVESTIGATOR’S QUALIFICATIONS AND AGREEMENTS should be qualified by education, training, and experience meet all the qualifications specified by the applicable regulatory requirement(s) with evidence Familiar with o Protocol, o Investigational Brochure o Investigational Product Aware of and comply .with GCP’s and applicable regulatory requirements. permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies) List of Qualified persons who are delegated trial related duties.
  6. 6. ADEQUATE RESOURCES
  7. 7. Adequate Resources Recruit number of suitable subjects within the agreed recruitment period Having sufficient time to conduct and complete within the agreed trial period Arrange adequate number of qualified staff and facilities for the duration of the trial to conduct the trial properly and safely Ensure that all persons assisting with the trial are adequately informed about the protocol, investigational products and their trial related duties and function
  8. 8. MEDICAL CARE OF TRIAL SUBJECTS
  9. 9. MEDICAL CARE OF TRIAL SUBJECTS Ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values Inform a subject when medical care is needed for intercurrent illness(es) Inform the subject’s primary physician about the subject’s participation Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the subject's rights.
  10. 10. COMMUNICATION WITH IRB/IEC
  11. 11. COMMUNICATION WITH IRB/IEC Before initiating a trial investigator should have: written and dated approval/favorable opinion from the IRB/IEC for the Trial protocol written informed consent form consent form updates subject recruitment procedures & other written information to be provided to subjects Investigator should provide current and updated { if made } copy of investigator brochure to IRB/IEC During the trial the Investigator should provide to the IRB/IEC all documents subject to review.
  12. 12. COMPLIANCE WITH PROTOCOL
  13. 13. COMPLIANCE WITH PROTOCOL Conduct the trial in compliance with the protocol agreed by sponsor and Regulatory authorities and sign the protocol, or an alternative contract, to confirm agreement. Should not implement any deviation from protocol without agreement by the sponsor and prior review. EXCEPT…. In emergency where necessary to eliminate immediate hazard to trial subjects or if change involves only logistical or administrative aspect of the trial ( eg. Change of monitor or change of telephone Numbers) Person designated by the Investigator, should document and explain any deviation from the approved protocol. As soon as possible, the implemented deviation or change, the reasons for it, and, if appropriate, the proposed Protocol amendment(s) should be submitted to sponsor, IRB/IEC and regulatory authorities
  14. 14. INVESTIGATIONAL PRODUCT(S)
  15. 15. INVESTIGATIONAL PRODUCT(S) MAINTAIN RECORDS Should maintain records of the product's  delivery to the trial site  inventory at the site  use by each subject  the return to the sponsor or  alternative disposition of unused product(s). STORAGE Should be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s). The investigator, or a person designated by the investigator, should explain the correct use of the investigational product(s) to each subject and should check, at intervals appropriate for the trial, that each subject is following the instructions properly. ENSURE The investigator should ensure that the investigational product(s) are used only in accordance with the approved protocol. EXPLAIN / CHECKING
  16. 16. RANDOMIZATION PROCEDURES AND UNBLINDING
  17. 17. RANDOMIZATION PROCEDURES AND UNBLINDING  The investigator should follow the trial's randomization procedures, if any, and should ensure that the code is broken only in accordance with the protocol.  If the trial is blinded, the investigator should promptly document and explain to the sponsor any premature unblinding (e.g., accidental unblinding, unblinding due to a serious adverse event) of the investigational product(s)
  18. 18. INFORMED CONSENT OF TRIAL SUBJECTS
  19. 19. INFORMED CONSENT OF TRIAL SUBJECTS While obtaining and documenting Informed consent, Investigator must - Comply with Regulatory Requirements Adhere to GCP Ethical principles from Declaration of Helsinki Prior to trial, investigator should have IRB/IEC’s written approval of- Written Informed consent form/ revised ICF For any other written information shared with subjects  Communication of revised ICF should be documented  No one should unduly force subject for participation  Ample time for enquiring about trial & all questions should be answered
  20. 20. - Language •Non- technical •that appears to waive legal rights of subject or release organizations/ people involved in CT from liability of negligence should NOT be used Legally Acceptable Representative(LAR) •Incase, subject is unable to give informed consent, investigator informs all the aspects of trial to LAR •Eg. Minors, Patient with dementia etc Impartial Witness •Incase, Subject/LAR unable to read •Signs ICF after Subject/LAR has given oral consent and if possible personally signed and dated •By signing ICF, Impartial witness attests that all information was accurately explained & understood by Subject/LAR  Prior to participation, Subject/LAR should receive a copy of ICF; any other written Information  and during participation copy of updated ICF ; any amendments in written information provided  Subjects who are enrolled after consent of LAR, should be informed about trial to extent of their understanding ICF continued..
  21. 21. ICF continued..
  22. 22. ICF continued..
  23. 23. - Non-therapeutic trial should be conducted only in subjects who can personally give consent, except in these situations. - Also, subjects should be closely monitored and withdrawn if they appear unduly distressed. When objectives of trial cannot be met with such subjects Foreseeable risks in subject are low Negative impact on subjects well being is minimized or low Trial is not prohibited by law Approval of IRB/IEC is expressly sought for inclusion of such subjects
  24. 24. Emergency situation, and Subject’s consent not possible LAR present Take consent LAR absent Measures prescribed in Protocol Documented approval of IRB/IEC to protect the rights, safety & well being of patients Ensure Compliance with regulatory requirements Inform Subject/ LAR as soon as possible ICF continued..
  25. 25. RECORDS AND REPORTS
  26. 26. RECORDS AND REPORTS The source documents and trial records should be maintained with adequacy and accuracy by the investigator Data reported to the sponsor in the CRF, that are derived from source documents, should be consistent with the source documents Any change or correction to a CRF should be dated, Initialed and explained and should not obscure the original entry(i.e. Audit trail should be maintained) The Investigator should maintain the trail documents as specified in the Essential documents for the conduct of a clinical trail. Measures should be taken to prevent accidental or premature destruction of these documents The financial aspects of the trail should be documented in agreement with the sponser and Investigator.
  27. 27. PROGRESS REPORTS
  28. 28. PROGRESS REPORTS Status Report Submit written summaries of the trial status to the IRB/IEC annually, or more frequently, if requested by the IRB/IEC. Risk Report Should promptly provide written reports to the sponsor, the IRB/IEC and, where applicable, the institution on any changes significantly affecting the conduct of the trial, and/or increasing the risk to subjects.
  29. 29. SAFETY REPORTING
  30. 30. SAFETY REPORTING All serious adverse events (SAEs) should be reported immediately to the sponsor EXCEPT for those SAEs that the protocol or other document (e.g., Investigator's Brochure)identifies as not needing immediate reporting. The immediate and follow-up reports should identify subjects by unique code numbers assigned to the trial subjects. Should follow regulatory requirements should report unexpected SAE’s to regulatory authorities Identified abnormalities & SAE’s in the protocol which are critical to safety evaluations should be reported within the time periods specified by the sponsor in the protocol. For reported deaths, the Investigator should supply the sponsor and the IRB/IEC with any additional requested information (e.g., autopsy reports and terminal medical reports).
  31. 31. PREMATURE TERMINATION OR SUSPENSION OF A TRIAL
  32. 32. PREMATURE TERMINATION OR SUSPENSION OF A TRIAL If the investigator terminates or suspends a trial without prior agreement of the sponsor If the sponsor terminates or suspends a trial If the IRB/IEC terminates or suspends its approval/favourable opinion of a trial The investigator should inform the institution where applicable, and the investigator should promptly inform the sponsor and the IRB/IEC, and should provide the sponsor and the IRB/IEC a detailed written explanation of the termination or suspension. The investigator should promptly inform the institution where applicable and the investigator should promptly inform the IRB/IEC and provide the IRB/IEC a detailed written explanation of the termination or suspension. The investigator should inform the institution where applicable and the investigator should promptly notify the sponsor and provide the sponsor with a detailed written explanation of the termination or suspension.
  33. 33. FINAL REPORT(S) BY INVESTIGATOR
  34. 34. FINAL REPORT(S) BY INVESTIGATOR should inform the institution should provide the IRB/IEC with a summary of the trial’s outcome should provide the regulatory authority(ies) with any reports required. COMPLETION OF TRIAL
  35. 35. REFERENCE
  36. 36. REFERENCE  https://database.ich.org/sites/default/fil es/E6_R2_Addendum.pdf

This Presentation was presented by Pruthvi raj, Tejaswini, and myself Bhavya Rajan at Clinosol Research Pvt Ltd. We would like to thank Clinosol and Mujeeb sir for this opportunity. for constantly supporting and encouraging us

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