RESPONSIBILITIES OF INVESTIGATOR PRESENTED BY: Ms. GAYATRI P. Ms. GARGI VASHISHTHA Dr. YOGITA KADAM Dr. VINAY BADGUJAR
Dec 28, 2015
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