Transcript What is the role of the PI and their staff?

Session 2 IRB Training
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What is the Principal Investigator’s role in Human
Subject Research?
What is the role of the Investigator’s staff in
Human Subject Research?
Who is the Principal Investigator ?
Federal regulation 21CFR 56.102 defines the
investigator as the individual who actually
conducts a clinical investigation (i.e., under whose
immediate direction the test article is administered
or dispensed to, or used involving, a subject) or, in
the event of an investigation conducted by a team
of individuals, is the responsible leader of that
team.
Who Regulates Human Subject
Research?
Human Subject Research is regulated by Federal and State
regulations and Lifespan policies.
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The two federal bodies come under HHS and they are FDA (Food and Drug
Administration) and OHRP (Office of Human Research Protection).
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Any federally funded research falls under OHRP and devices and drugs fall
under the jurisdiction of FDA as well as OHRP.
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The State of RI Regulations can be located www.rules.state.ri.us under the
Rules and Regulations for Licensing of Hospitals R23-17-16
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Lifespan Policies
Responsibility of the PI
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Is to know and understand these regulations and
policies prior to initiating any human research.
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Acknowledge and accept their role to protect the rights
and welfare of the research subjects by complying with
all of the regulations.
So what is GCP and how does it fit in?
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When a principal investigator receives a Human Subjects Protection Approval letter
from the Lifespan IRB, they are notified that this institution and the investigator
complies with ICH GCP guidelines as they correspond to the FDA/DHHS regulations.
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Good Clinical Practice (GCP) is an international ethical and scientific quality standard
for designing, conduction, recording and reporting trials that involve the participation of
human subjects.
Compliance with GCP standards:
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provides public assurance that the rights, safety and well being of trial subjects
are being protected
clinical trial data are credible.
So what are the PI Responsibilities
according to GCP?
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The investigator’s responsibility according to ICH GCP
guidelines:
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4.1
4.2
4.3
4.4
4.5
4.6
4.7
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4.10
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4.12
4.13
Investigator qualifications and agreements
Adequate resources
Medical care of trial subjects
Communication with IRB
Compliance with the protocol
Investigational product
Randomization procedures and unblinding
Informed consent of trial subjects
Records and reports
Progress reports
Safety reporting
Premature termination or suspension of a trial
Final report by the investigator
4.1 Investigator’s qualifications
and agreements
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Is the PI qualified by education, training and experience to
assume the responsibility for the proper conduct of the
trial? The IRB verifies this by requesting a copy of all CV
and that they are updated every 2 yrs. FDA requires Form
1572
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Is the PI well versed with the use of the investigative
product? Are all the co-investigator’s trained?
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Does the PI maintain a list of appropriately qualified
persons and the significant trial duties they have been
delegated?
4.2 Adequate Resources
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Has the PI been able to demonstrate a potential for
recruiting the required number of suitable subjects within
the recruitment period?
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Is their adequate qualified staff and resources to conduct
the trial properly and safely?
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Have all persons assisting with the trial been adequately
trained about the protocol? Their related duties and
functions?
4.3 Medical Care of Trial Subjects
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Is there a qualified physician (PI or Co-PI) responsible for
all trial related medical decisions?
During or following participation in a trial, the PI must
ensure that adequate medical care is provided for any
adverse event. The Investigator should inform a subject
when medical care is needed for a concurrent illness.
GCP recommends that a PI inform the subjects primary
physician about participating in the trial if the subject has
no objections!
Does the PI make a reasonable effort to ascertain the
reasons why a subject withdraws from the study?
4.4 Communication with the IRB
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Before starting any trial, does the PI have written approval
from the IRB for the study? (Including written IC,
recruitment procedures including advertisements and any
other written materials to be given to the subjects)
Are all IB’s sent to the IRB whenever they are updated?
During the study trial, have all new documents been sent to
the IRB for review?
4.5 Compliance with the Protocol
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Is the PI conducting the study according to the protocol
that has been approved by the IRB?
If there is a deviation from the protocol, the sponsor and
the IRB needs to be informed.
However, the PI may implement a deviation or change to
eliminate an immediate hazard to the subject without
prior approval, but ASAP must notify and submit all
necessary forms to the IRB, sponsor and /or the regulatory
authorities.
Has the PI or designee documented and explained any/all
deviations from the protocol?
4.6 Investigational Product
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Is there an accountability receiving/dispensing log for all drugs or
devices?
Is the Pharmacy performing this functions and maintaining the
records?
If not, does the PI have the appropriate records that document delivery,
inventory, who received each device/drug, return of the product and
it’s disposal. Are the dates, quantities, batch/serial numbers, expiration
dates of all doses recorded? How is it stored?
Do you have documentation that the correct use has been explained to
each subject? Is there any documentation that you have checked at
intervals to see if they are following the correct instructions?
4.7 Randomization Procedures and
Unblinding
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Has the PI followed the trial’s randomization procedures
outlined in the protocol?
If the code is broken (unblinded), did the PI promptly
document and explain to the sponsor the circumstances
surrounding the incident? (such as accidental, or due to a
serious adverse event)
4.8 Informed consent of trial subjects
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Before beginning a trial, the PI needs an IRB approval of
the Informed Consent to be used.
The regulations stipulate what needs to be in the informed
consents.
Obtaining Informed Consent is a process not just the
signing of the document and occurs throughout the
subject’s participation in a trial.
4.9 Records and Reports
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Can the PI ensure the accuracy, completeness, legibility and timeliness
of the data reported to the sponsor?
Can the data reported on CRF’s be verified by the source documents?
Any discrepancies need to explained by a note to file.
CRF’s should be dated and signed by the person completing the forms
and any changes or corrections need to be done correctly. A line
through the entry and a date and initial next to the correction. The
original entry can never be obliterated (i.e. no white out/crossing out
completely)
Essential documents need to be retained until at least 2 years after the
last approval of a marketing application and/or the discontinuance of
clinical development. RI State Law requires 5 years!
So what are some of the other PI
requirements?
What is the HIPAA Authorizations for Research?
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When the research involves the use or disclosure of PHI, unless
otherwise noted, you are responsible for obtaining an authorization
from prospective subjects.
Only copies of the signed, IRB approved research authorization,
may be utilized during the period of time your research has IRB
approval to enroll subjects.
All subjects must be given signed copies of the authorization.
Keep the originals in your secured research files and,
When appropriate, you should place copy of the authorization in
the subject’s medical record.
What about required trainings?
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Human Subject Protection (HSP) Training is required of investigator’s
and the research personnel participating in the research study before an
approval letter is granted. This includes all persons listed on the
“abstract” as “key personnel”. Re-certification is required every 3
years.
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Each PI must also sign a HIPAA Security Certificate annually.
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HIPAA for Research is an annual requirement. Each department in
Lifespan must provide this training to their employees.
The research department has provided a HIPAA module along with the
HSP and GCP modules on the CITI training site which can be reached
by logging onto the site at http://www.citiprogram.org
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What is the role of the Investigator’s staff in
Human Subject Research?
Any individuals working on a Human Subject
Research Project falls under the supervision
and direction of a PI and may be involved in
some or all of the following:
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Do you oversee the planning, scheduling, and implementation of
day-to-day clinical activities and procedures?
Are you responsible for:
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Planning or the carrying out the programs for:
Recruitment,
 Screening and Enrollment
 Do you instruct subjects on treatment methods and
the protocol?
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Or you might be involved with
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Setting up and maintaining the data collection
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Ensures that all clinical activities are carried out
according to the protocol
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Do you monitor and record patient response to
treatment, and communicate the study data and
results to investigators?
Are you the person who
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Develops and/or coordinates the maintenance of records on
medication dispensation and inventory usage during the
course of the study
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Administers prescribed study medications, performs
phlebotomy, monitors vital signs, and/or performs other
specialized nursing procedures, as appropriate to the
specific needs of the study and individual subjects.
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Ensures the confidentiality of subject records?
Thoughts for successful clinical trials
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The safety and well-being of your study subjects always comes first.
The need to establish a good, collegial working relationship with your
investigator, IRB, sponsor, monitors and the rest of the research
community.
To know your protocols and CRF’s thoroughly.
Keep organized.
Read the Federal, State and Institutional regulations/policies.
Keep handy a copy of the GCP guidelines.
Don’t be afraid to admit you don’t know something…find out.
Contact me @ 444-5843 or email [email protected]