RESPONSIBILITIES OF INVESTIGATOR

PRESENTED BY:Ms. GAYATRI P.

Ms. GARGI VASHISHTHA

Dr. YOGITA KADAM

Dr. VINAY BADGUJAR

CONTENTSINTRODUCTIONSELECTIONINVESTIGATOR AGREEMENTUNDERTAKING FORM 1572RESPONSIBILITIESRELATIONSHIP WITH SPONSORSTATISTICIAN & CRCEXAMPLES OF INVESTIGATORSUMMARY

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.

SELECTION OF INVESTIGATOR

Education

Training

Experience

The sponsor is responsible for selecting the investigator(s)/ institution

INVESTIGATOR’S AGREEMENT

Adherence to Protocol, GCP, Regulatory guidelines

Acceptance of monitoring, audits, inspections

Timely completion of study and all required documentation

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”

RESPONSIBILITIES OFINVESTIGATOR

Investigator

Regulatory Compliance

Ethics Approval

Informed Consent

Medical CareStaff Supervision

Investigational Product

Safety Reporting

Records Reports

Monitoring /Audit

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

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

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

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

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

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

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

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

8.RANDOMIZATION AND UNBLINDING

Follow trial’s randomization procedures If trial is blinded - Document and elucidate for any premature

unblinding

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

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

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

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

13. FINAL REPORTING

Provide the sponsor with all required reports Summary of the trial’s outcome to be provided to -

IRB/IEC regulatory authorities

RELATIONSHIP BETWEEN INVESTIGATOR & SPONSOR

Sponsor Investigator

Conducts

Chooses

Clinical trial

Monitors

STATISTICIAN & CRCSTATISTICIAN 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

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

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

REFERENCES• www.hms.harvard.edu/integrity/clinical.html• www.rochester.edu/ORPA/rules/roles_pi.htm• www.clinicaltrials.gov/ct2/invest• www.issuesinmedicalethics.org/083or084.html• www.medtran.ru/eng/trials/trialdocumentation.htm

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