This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines Required mainly for Regulatory affairs students

1. Roles and Responsibilities of sponsor, CRO,
and investigator in ethical conduct of clinical
research
Subject :- Clinical Research Regulation
Presented By :-
Mohammed Saleem JM
I Sem M Pharm
Dept of Pharmaceutics and Regulatory Affairs
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2. SPONSOR :-
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WHO IS SPONSER ?
PHARMACEUTICAL
COMPANY
INDIVIDUAL
GOVERNAMENT
AGENCY
ACADEMIC
INSTITUTION
PRIVATE
ORGANIZATION

3. Sponsor
• Sponsor is an individual, company, inistitution or organization which
takes responsibility for the initiation, management,and/or financing
of a clinical trial
Sponsor team contain following
• Project manager
• CRA/Monitor
• CRO(Contract research organization)
• Data manager
• Bioststistican
• Medical writer 3

4. Responsibilities of sponsor
Quality Management
The sponsor should implement a system to manage quality throughout
all stages of the trial process.
Sponsor should focus on trial activities essential to ensuring human
subject protection and the reliability of trial results. Quality
management includes the design of efficient clinical trial protocols and
tools and procedures for data collection and processing,as well as
collection of information that is essential to descission making.
The methods used to assure and control the quality of the trial should
be proportionate to the risk inherent in the trial and the importance of
the information collected.
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5. The sponsor should ensure that all aspect of the trial are operationally
feasible and should avoid unnecessary complexity, procedures and data
collection. Protocols, case report forms, and other operational documents
should be clear concise, and consistent.
The quality management system should use a risk- based approach as
described below:-
• Critical Process and Data Identification
• Risk identification
• Risk evaluation
• Risk control
• Risk communication
• Risk review
• Risk reporting
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6. • Critical Process and Data Identification:- During protocol
development, the sponsor should identify those processes and data
that are critical to ensure human subject protection and the reliability
of trial results.
• Risk Identification :- The sponsor should identify risks to critical trial
processes and data. Risks should be considered at both the system
level (e.g., standard operating procedures, computerized systems,
personnel) and clinical trial level (e.g., trial design, data collection,
informed consent process).
• Risk Review:- The sponsor should periodically review risk control
measures to ascertain whether the implemented quality
management activities remain effective and relevant, taking into
account emerging knowledge and experience.
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7. Quality Assurance and Quality Control
• The sponsor is responsible for implementing and maintaining quality
assurance and quality control systems with written SOPs to ensure that
trials are conducted and data are generated, documented (recorded), and
reported in compliance with the protocol, GCP, and the applicable
regulatory requirements.
• Quality control should be applied to each stage of data handling to ensure
that all data are reliable and have been processed correctly.
• Agreements, made by the sponsor with the investigator/institution and any
other parties involved with the clinical trial, should be in writing, as part of
the protocol or in a separate agreement.
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8. CRO (Contract Research Organization)
• A contract research organization (CRO) is a company that
provides support to the pharamaceutical, biotechnology,and
medical device industries in the form of research services
outsoursed on a contract basis. A CRO may provide such
services as biopharmaceutical development, biological assay
development, commercialization, preclinical research, clinical
trials management, and pharmacovigilance.
• CROs are designed to reduce costs for companies developing
new medicines and drugs in niche markets . They aim to simplify
entry into drug markets, and simplify development, as the need
for large pharmaceutical companies to do everything ‘in house’ is
now redundant. CROs also support foundations, research
institutions, and universities, in addition to governmental
organizations (such as the NIH,EMA, etc.)
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9. • A sponsor may transfer any or all of the sponsor's trial-related duties
and functions to a CRO, but the ultimate responsibility for the quality
and integrity of the trial data always resides with the sponsor. The
CRO should implement quality assurance and quality control.
• Any trial-related duty and function that is transferred to and assumed
by a CRO should be specified in writing.
CRO Roles and responsibilities:-
• Provide investigators with information they need to conduct an
investigation properly.
• Ensure proper monitoring of the investigations
• Ensure study is conducted in accordance with study plan and
protocol
• Control investigational products
• Safety reporting 9

10. INVESTIGATOR
Who is an Investigator?
• An individual who actually conducts a clinical investigation (i.e., under
whose immediate direction the drug is dispensed to a subject.)
• In the event an investigation is conducted by a team of individuals, the
investigator is the responsible leader of the team.
SPONSER INVESTIGATOR
An individual who both initiates and conducts an investigation, and under
whose immediate direction the investigational drug is administered or
dispensed.
• The term does not include any person other than an individual.
• The requirements applicable to a sponsorinvestigator include both those
applicable to an investigator and a sponsor.
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11. Roles and responsibilities of investigator
Investigator's Qualifications and Agreements
• The investigator should be qualified by education, training, and
experience to assume responsibility for the proper conduct of the
trial, should meet all the qualifications specified by the applicable
regulatory requirements, and should provide evidence of such
qualifications through up-to-date curriculum vitae and/or other
relevant documentation requested by the sponsor, the IRB/IEC,
and/or the regulatory authorities
• The investigator should be aware of, and should comply with, GCP
and the applicable regulatory requirements.
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12. Adequate Resources
• The investigator should have sufficient time to properly conduct and
complete the trial within the agreed trial period.
• The investigator should 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.
Medical Care of Trial Subjects
• A qualified physician (or dentist, when appropriate), who is an
investigator or a subinvestigator for the trial, should be responsible
for all trial-related medical (or dental) decisions.
• During and following a subject's participation in a trial, the
investigator/institution should ensure that adequate medical care is
provided to a subject for any adverse events, including clinically
significant laboratory values, related to the trial.
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13. Communication with IRB/IEC
• Before initiating a trial, the investigator/institution should have
written and dated approval/favourable opinion from the IRB/IEC for
the trial protocol, written informed consent form, consent form
updates, subject recruitment procedures (e.g., advertisements), and
any other written information to be provided to subjects.
• During the trial the investigator/institution should provide to the
IRB/IEC all documents subject to review.
Compliance with Protocol
The investigator/institution should conduct the trial in compliance with
the protocol agreed to by the sponsor and, if required, by the
regulatory authorities and which was given approval/favourable
opinion by the IRB/IEC. The investigator/institution and the sponsor
should sign the protocol, or an alternative contract, to confirm
agreement.
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14. Investigational Products
• Responsibility for investigational products accountability at the trial
sites rests with the investigator/institution.
• The investigator should ensure that the investigational products are
used only in accordance with the approved protocol.
Records and Reports
• The investigator/institution should maintain adequate and accurate
source documents and trial records that include all pertinent
observations on each of the site’s trial subjects. Source data should
be attributable, legible, contemporaneous, original, accurate, and
complete.
• The investigator should ensure the accuracy, completeness, legibility,
and timeliness of the data reported to the sponsor in the CRFs and in
all required reports.
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15. Progress Reports
• The investigator should submit written summaries of the trial status
to the IRB/IEC annually, or more frequently, if requested by the
IRB/IEC.
Safety Reporting
• Adverse events and/or laboratory abnormalities identified in the
protocol as critical to safety evaluations should be reported to the
sponsor according to the reporting requirements and within the time
periods specified by the sponsor in the protocol.
• 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).
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16. Premature Termination or Suspension of a Trial
• If the investigator terminates or suspends a trial without prior
agreement of the sponsor, the investigator should inform the
institution where applicable, and the investigator/institution should
promptly inform the sponsor and the IRB/IEC, and should provide the
sponsor and the IRB/IEC a detailed written explanation of the
termination or suspension.
Final Reports by Investigator
• Upon completion of the trial, the investigator, where applicable,
should inform the institution; the investigator/institution should
provide the IRB/IEC with a summary of the trial’s outcome, and the
regulatory authorityies with any reports required.
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17. References
• GUIDELINE FOR GOOD CLINICAL PRACTICE (ich.org)
• https://www.fda.gov/media/75775/download
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