Responsibilities of Sponsor,

Investigator and Monitor

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Learning Objective

Roles and Responsibilities of the

 Sponsor

 Investigator

 Clinical research associate

 Clinical research coordinator

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 Key Players in a Clinical Trial

CRA

Investigator Patient

Clinical
Trial

Regulatory Ethics
Authorities Committee

Sponsor
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Sponsor

 Who is Sponsor?

An individual, company, institution, or organisation

which takes responsibility for the

 Initiation

 Management

 Financing of a clinical trial.

ICH E6, 1.53

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Sponsor’s Responsibilities

 Quality Assurance & Quality Control

 To ensure that trials are conducted & data are generated,
documented & reported in compliance with the protocol,
GCP & applicable regulatory requirements.
 To ensure direct access to trial related data by the
sponsor or inspector (auditor).

 Medical Expertise
 Should designate qualified medical personnel to advise
trial related medical questions

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Sponsor’s Responsibilities…cont’d

 Trial Design
 Trial management, data handling, record keeping
 Investigator selection
 Compensation to Subjects & Investigators
 Provide insurance or indemnity to subjects or investigator /
institution
 Financing
 Financial written agreement between sponsor & investigator
 Application to regulatory body for permission to conduct the
trial

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 Sponsor’s Responsibilities…cont’d

 Information on investigational product

 Ensure that sufficient safety & efficacy data from non

clinical studies are available to support human exposure

 Manufacturing & packaging of IP

 Ensure that IP is manufactured as per applicable GMP and
appropriately coded, labeled & packaged

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Sponsor’s Responsibilities…cont’d

 Safety information
 Responsible for ongoing safety evaluation of IP

 Monitoring & Audit

 To ensure that conduct of trial is in accordance with
approved protocol

 Clinical Study Reports

 To prepare and provide reports to regulatory authorities

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Investigator
 Who is Investigator?

A person responsible for the conduct of the clinical

trial at a trial site.

If a trial is conducted by a team of individuals at a

trial site, the investigator is the responsible leader
of the team and may be called as Principal
Investigator.

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Investigator’s Responsibilities

 Qualifications and Agreements

 Should be qualified by education, training and experience
to assume responsibility for the proper conduct of trial
 Permit monitoring and auditing by sponsor and inspection
by regulatory authority
 Adequate Resources
 Should be able to demonstrate a potential for recruiting
the required number of suitable subjects
 Sufficient time, adequate number of qualified staff and
adequate facilities

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Investigator’s Responsibilities…cont’d

 Medical Care of Trial Subjects

 Responsible for all trial related medical decisions and
ensure that adequate medical care is provided to a
subject for any AE related to trial
 Communication with IRB/IEC
 Written and dated approval from IRB/IEC before
initiating the trial
 Keep IRB/IEC apprise of all deviations, SAEs & progress
during the study

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Investigator’s Responsibilities…cont’d

 Compliance with Protocol

 Conduct the study according to protocol
 No deviation from protocol without agreement by the
sponsor & prior review/approval from IRB/IEC

 Investigational Product
 IP accountability & maintenance of records of the
product’s delivery to the site, inventory at site, use by the
subject, return to sponsor or destruction.
 Storage & use of IP according to protocol

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Investigator’s Responsibilities…cont’d

 Informed Consent of Study Subjects

 Provide IRB/IEC approved written informed consent form
to subject
 Should not coerce or unduly influence subjects to
participate
 Language of informed consent form should be
nontechnical and understandable to the subject
 Subject should be given ample time and opportunity to
ask questions
 Subject should sign and personally date informed consent
form prior to initiation of study procedures

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Investigator’s Responsibilities…cont’d

 Records & Reports

 Accuracy, completeness, legibility & timelines of the data
reported in CRF

 Progress Reports
 Written summaries of status of the trial to IRB/IEC
annually or as required by IRB/IEC
 Safety Reporting
 All SAEs should be reported to sponsor immediately
 AE or lab abnormalities identified as critical in protocol
should be notified to sponsor.

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Investigator’s Responsibilities…cont’d

 Premature Termination or Suspension of Trial

 Inform subjects, ensure appropriate therapy & follow up of
the subjects

 If investigator or sponsor terminates/suspends trial – inform

institution & IRB/IEC

 Final Reports
 Provide summary of trial outcome to institution and IRB/IEC

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CRA / Monitor

Who is CRA?
 Acts as main line of communication between sponsor and

the investigator.

 Visit & work with sites on behalf of sponsor

 Performs variety of clinical operations & monitoring

activities

 Often called as ‘Clinical Monitor’ or ‘Study Monitor’

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CRA’s Responsibilities

Feasibility of trial Recruiting Investigators

Not acceptable Pre-Study Visits

Acceptable Site Initiation Visits

Routine Monitoring Visits

Site Close Out Visits

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CRA’s Responsibilities…cont’d

 Evaluating & Selecting the investigators

 The Monitor is responsible for selecting the
investigator/institution. Each investigator should be
qualified by
 training
 experience and should have
 adequate resources
to properly conduct the trial for which the investigator is
selected

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CRA’s Responsibilities…cont’d

 Pre Study Visit (site selection visit)

 Conducted at a potential research site

 Assess the investigator’s experience, staff, facility and

potential patient population

 Introduce the study & obligations to the potential

investigator & staff

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CRA’s Responsibilities…cont’d

 Site Initiation Visit

 Conducted at a confirmed research site

 Verify the confirmed investigator’s experience, staff,

facility and potential patient population

 Detail the study & obligations to the potential

investigator & staff

 Collect all essential documents before this visit

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CRA’s Responsibilities…cont’d

 Routine Monitoring Visit

 CRA’s main activity – study monitoring

 Purpose of monitoring:

 rights & well being of subjects are protected

 reported data are accurate, complete & verifiable

from source documents

 trial conduct is in compliance with protocol, GCP &

applicable regulatory requirements

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CRA’s Responsibilities…cont’d

 Routine Monitoring Visit

 Review IP handling, storage conditions, receipt, use,
return and disposition

 Review all informed consent forms

 Review protocol compliance

 Review CRFs, source documents, site file

 Review AEs/SAEs

 Review facilities, resources, staffing

 Address questions and/or concerns

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CRA’s Responsibilities…cont’d

 Site Close out Visit

 Site close out visit is conducted when

 Study is complete & finished

 Enrollment has stopped

 All subjects have completed their study related

activities

 Data are complete & correct

 Final IP accountability is done

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CRA’s Responsibilities…cont’d

 Site Close out Visit

 Site close out visit is conducted to

 Retrieve all appropriate study supplies

 Verify that study documentation is complete &

accurate

 Ensure that site is in compliance with regulatory &

GCP guidelines

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Thank you

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