4.1.2 investigator.pptx

investigator
purpose of investigator
role of investigator in study

1. Responsibilities of Investigators GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95)

2. 2 Responsibilities of an Investigator Qualification and Agreements Adequate Resources Medical Care of Trial Subjects Communication With IRB/ ERC Compliance with Protocol Drug Accountability Randomization & Blinding Informed Consents Records & Reports Safety Reporting Final Reports Guidelines for Good Clinical Practice 2002 ICH Harmonised Tripartite Guideline, CPMP/ICH/135/95

3. 3 Investigator: Qualification & Agreements An investigator should be: Qualified by education, training, and experience Familiar with the appropriate use of the investigational product(s), as described in the protocol the current Investigator's Brochure product information Aware of, and complies with, GCP and the applicable regulatory requirements. Able to permit monitoring/auditing by the sponsor or inspection by the regulatory authority. Maintaining a list of qualified persons to whom he/she delegates significant trial-related duties. Guidelines for Good Clinical Practice 2002 ICH Harmonised Tripartite Guideline, CPMP/ICH/135/95

4. 4 Investigator: Adequate Resources An Investigator should : Demonstrate a potential for recruiting the required number of suitable subjects within the agreed recruitment period. Have time to properly conduct and complete the trial within the agreed trial period. Have available an adequate number of qualified staff and adequate facilities for the foreseen 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 product(s), and Their trial-related duties and functions Guidelines for Good Clinical Practice 2002 ICH Harmonised Tripartite Guideline, CPMP/ICH/135/95

5. 5 Investigator: Medical Care of Trial Subjects The investigator should: Be responsible for all trial-related medical decisions Ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial Advise a subject when medical care is needed for intercurrent illness Inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed Make a reasonable effort to ascertain the reason for a subject to withdraw prematurely from a trial while fully respecting the subject's rights. Guidelines for Good Clinical Practice 2002 ICH Harmonised Tripartite Guideline, CPMP/ICH/135/95

6. 6 Investigator: Communication with IRB The investigator should achieve the following : Written and dated approval from the IRB/IEC for the trial Protocol or its amendments Informed consent form and its updates Subject recruitment procedures (e.g., advertisements) and Other written information to be provided to subjects Investigator should provide with a current copy of the Investigator's Brochure Any updates on the Investigator's Brochure should also be provided to the IRB/IEC. Guidelines for Good Clinical Practice 2002 ICH Harmonised Tripartite Guideline, CPMP/ICH/135/95

7. 7 Investigator: Compliance with Protocol The investigator should : Conduct the trial in compliance with the protocol Sign the protocol, or a contract, to confirm agreement with the sponsor Not deviate from, or change the protocol without agreement by the sponsor unless: to eliminate an immediate risk to trial subjects changes involve logistical or administrative aspects of the trial e.g., change in monitor, change of telephone number Document and explain any deviation from the approved protocol Obtain sponsor/designee approval, as appropriate, for recruitment or continuation of a recruited subject, when a significant protocol deviation is observed Guidelines for Good Clinical Practice 2002 ICH Harmonised Tripartite Guideline, CPMP/ICH/135/95

8. 8 Investigator: Medical Care of Trial Subjects The investigator should: Be responsible for all trial-related medical decisions Ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial Inform a subject when medical care is needed for intercurrent illness Inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed Make a reasonable effort to ascertain the reason for a subject to withdraw prematurely from a trial while fully respecting the subject's rights. Guidelines for Good Clinical Practice 2002 ICH Harmonised Tripartite Guideline, CPMP/ICH/135/95

9. 9 Investigator: Investigational Product Responsibility for investigational product accountability at the site rests with the investigator Assign duties for drug accountability to a staff under the supervision of the investigator Maintain records for the investigational product at the site for: delivery inventory storage use by each subject product reconciliation return to the sponsor or alternative disposition of unused/damaged product Records should include dates, quantities, batch/serial numbers, expiry dates and the unique code numbers assigned to the product and trial subjects. Explain the correct use of the investigational product to each subject and ensure drug compliance. Guidelines for Good Clinical Practice 2002 ICH Harmonised Tripartite Guideline, CPMP/ICH/135/95

10. 10 Investigator: Informed Consent Obtain IRB/IEC approval for the Informed Consent and its revisions Ensure simple language that is comprehensible by lay men Elaborate all aspects of the trial, its foreseeable risks to the subject and compensations Allow time for the subject to make a conscious and an informed decision Do not coerce or unduly influence a subject to participate or to continue to participate in a trial Ensure patient privacy and confidentiality Legally acceptable attendants of a subject can sign on patients behalf when the subject is a child (<7y), mentally retarded, illiterate, etc. Guidelines for Good Clinical Practice 2002 ICH Harmonised Tripartite Guideline, CPMP/ICH/135/95

11. 11 Investigator: Records & Reports Ensure the accuracy, completeness, legibility, and timeliness of the data Data reported on the CRF, should be consistent with the source documents Changes or correction to a CRF should be dated, initialed and explained Essential documents kept for at least 2 years after marketing approval The financial agreement between the sponsor and the investigator For monitoring or audit, all trial related records should be allowed free access to Submit written summaries of the trial status to the IRB/IEC and the sponsor Report any changes affecting the conduct of the trial, and/or increasing the risk to subjects. Guidelines for Good Clinical Practice 2002 ICH Harmonised Tripartite Guideline, CPMP/ICH/135/95

12. 12 Investigator: Safety Reporting All serious adverse events (SAEs) should be reported immediately The immediate reports should be followed promptly by detailed, written reports. Avoid breaching subject privacy by using unique identification codes Comply with the applicable regulatory requirement related to the reporting of unexpected serious adverse drug reactions to the regulatory authority and the IRB/IEC. Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor 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. Guidelines for Good Clinical Practice 2002 ICH Harmonised Tripartite Guideline, CPMP/ICH/135/95