1. RESPONSIBILITIES OF INVESTIGATOR
PRESENTED BY:
Ms. GAYATRI P.
Ms. GARGI VASHISHTHA
Dr. YOGITA KADAM
Dr. VINAY BADGUJAR

2. CONTENTS INTRODUCTION SELECTION INVESTIGATOR AGREEMENT
UNDERTAKING FORM 1572
RESPONSIBILITIES
RELATIONSHIP WITH SPONSOR
STATISTICIAN & CRC
EXAMPLES OF INVESTIGATOR
SUMMARY

3. INTRODUCTION
An investigator is a person responsible for the conduct of the clinical trial at a trial site.
The principal investigator is responsible for the collection, quality, recording, maintenance and retrieval of source data arising from the clinical study. PI must sign an FDA Form 1572 prior to the start of each clinical trial
Sub-investigator: An individual designated and supervised by the investigator to perform trial related procedures, including trial-related decisions.

4. SELECTION OF INVESTIGATOR
The sponsor is responsible for selecting the investigator(s)/ institution
Education
Training
Experience

5. INVESTIGATOR’S AGREEMENT
Adherence to Protocol, GCP, Regulatory guidelines
Acceptance of monitoring, audits, inspections
Timely completion of study and all required documentation

6. UNDERTAKING FORM 1572
Agree to comply with protocol, personally conduct or supervise the study, inform subjects about investigational drug, comply with IRB requirements, report AEs, familiar with IB.
Ensure that study personnel know obligations in meeting study commitments.
Maintain adequate/accurate records, to be made available for inspection (FDA, etc.)
Update when add key personnel to study who will have participant contact.
“Contract” that investigator signs/dates
“WARNING: A willfully false statement is a criminal offense”

7. RESPONSIBILITIES OF INVESTIGATOR
Monitoring /Audit
Records Reports
Regulatory Compliance
Investigator
Safety Reporting
Ethics Approval
Informed Consent
Investigational Product
Staff Supervision
Medical Care

8. 1. ADEQUATE RESOURCES
Exhibit a potential for recruiting required number of suitable subjects
Should have sufficient time to conduct trial
Maintain qualified persons and assign significant trial-related duties, should be informed of SOP, IP(s)
Adequate facilities

9. 2. MEDICAL CARE OF TRIAL SUBJECTS
Qualified Physician responsible for all trial-related medical decisions
Adequate medical care during and after study, for adverse events and inter-current illnesses
Information to subject’s primary physician of participation (subject to patient’s consent)
Exert reasonable effort to ascertain patient’s reasons for withdrawing

10. 3. COMMUNICATION WITH IRB
Before initiating a trial obtain written approval from ethics committee (IRB/IEC) for
Protocol
Written Informed consent form
Consent form updates
Subject recruitment procedures
Any information to be provided to the subject
Investigator’s Brochure and its updates, if any

11. 4. COMPLIANCE WITH PROTOCOL
Conduct trial in compliance with protocol
Make deviation in a protocol only after notifying the sponsor and the IRB/IEC
Except where necessary to eliminate apparent, immediate hazard(s) to the trial subjects
Document and justify deviation from approved protocol

12. 5. INVESTIGATIONAL PRODUCT
Investigational product(s) accountability.
Assign individuals at the sites for -
Product’s delivery to trial site-
Date
Quantities
Batch/serial number
Expiry dates
Code number
Subject were provided doses specified
Storage of the products.
Explain correct use of IP to subject and check subject’s compliance

13. 6. PATIENT RECRUITMENT Ensure unbiased selection according to protocol
Cooperation of other physicians
Inclusion criteria
Confidential list of all study subjects
Maintain subjects screening log
Maintain subjects enrolment log
Adequate information to subjects about the trial

14. 7. INFORMED CONSENT OF TRIAL SUBJECTS
Obtain informed consent from subject or subject’s legally acceptable representative
Prior to beginning of protocol treatment
Prior to randomizing patients if the study is a randomized trial

15. Comply and adhere to ICH –GCP
Revise the form on availability of new information.
No undue influence, Non technical, understandable language
No information should cause subject to waive any legal rights
Subject’s legally acceptable representative.
Provide ample time and opportunity.
Signed and personally dated
Role of impartial witness

16. 8.RANDOMIZATION AND UNBLINDING
Follow trial’s randomization procedures
If trial is blinded -
Document and elucidate for any premature unblinding

17. 9. RECORDS & REPORTS
Ensure the accuracy, completeness, legibility and timeliness.
Data reported on CRF should be consistent.
Any change or correction in CRF should be dated, initialed and explain. written procedure to assure the changes
Maintain trial documents.
Essential documents to be retained for 2 years
Financial aspects to be documented
Direct access to all records

18. 10.PROGRESS REPORTS Submit written summaries of trial status
Report progress of approved research to the IRB, as often and in the manner prescribed by the IRB
Promptly report any changes –
affecting conduct of trial
increasing the risk to subjects

19. 11. SAFETY REPORTING SAEs to be reported to sponsor immediately
AE/Lab abnormalities identified in the protocol to be reported.
For reported deaths - information on autopsy reports and terminal medical reports to sponsor and IRB/IEC

20. 12. SUSPENSION OF TRIAL
Promptly inform trial subjects and assure suitable therapy and follow-up
Written explanation of termination or suspension
If sponsor terminates –inform the institution and the IRB/IEC.
If IRB/IEC terminates – inform the institution and the sponsor

21. 13. FINAL REPORTING Provide the sponsor with all required reports
Summary of the trial’s outcome to be provided to -
IRB/IEC
regulatory authorities

22. RELATIONSHIP BETWEEN INVESTIGATOR & SPONSOR
Chooses
Conducts
Monitors
Clinical trial

23. STATISTICIAN & CRC STATISTICIAN
Involved at planning stage as well as throughout the study
Actively engaged in design, conduct, final analysis
The number of subjects planned to be enrolled
CRC- Clinical Research Coordinator
professionals coordinate with prime investigators
conduct trials by complying with GCP under watchful eye of PI
perform diverse duties

24. EXAMPLES OF INVESTIGATOR
Evaluating an ICCS in lung cancer – James Cleary, Lori DuBenske
Identification, Prevalence & Lifespan of Rapid onset Dystonia-Parkinsonism – Allison Brashear
Weekly Dosing of Malarone for prevention of Malaria – Gregory Deye
Pre-Exposure Prophylaxis to Prevent Acquisition Within HIV – 1 Discordant couples – Connie Celum, Jared Baeten

25. SUMMARY
An investigator is essential to carry out safe and successful trials
By following protocol; comply with IRB
Document every single aspect of the trial, maintain records, report AEs

26. REFERENCES www.hms.harvard.edu/integrity/clinical.html

27. ACKNOWLEDGEMENT
We take this opportunity to thank the professors for their help and support who made this project report possible. We also extend our thanks to our group mates for their contribution of hard work in the project Suggestions and advice to improve our seminar will be appreciated