ROLES AND

RESPONSIBILITIES OF
AN INVESTIGATOR

Dr. Juanna Jinson

Scientific Writer
Department Of Clinical Pharmacology
SRM Medical College Hospital And Research Centre
 Introduction

• Investigator - Section 2 of ICH GCP E6 R2

S.No Sub-section S.No Sub-section

2.1 Qualifications and training 2.8 Informed Consent of Trial Participants
2.2 Resources 2.9 End of Participation in a Clinical Trial
2.3 Responsibilities 2.10 Investigational Product Management
2.4 Communication with IRB/IEC 2.11 Randomization Procedures & Unblinding
2.5 Compliance with Protocol 2.12 Records
2.6 Premature Termination or Suspension of 2.13 Clinical Trial/Study Reports
Trial
2.7 Participant Medical Care & Safety Reporting
2.1 Qualifications and Training

• Have adequate education, training and experience

• Provide evidence of such qualifications
• Be familiar with the use of the investigational product(s) (as described in the
protocol, current Investigator’s Brochure, product information and/or in other
information sources provided by the sponsor)
2.2 Resources

• Should demonstrate potential for recruiting the proposed number of participants

within the recruitment period
• Sufficient time
• Adequate number of available and qualified staff
• Adequate facilities to conduct the trial properly and safely
2.3 Responsibilities

• May delegate trial-specific activities to other persons or parties

• Supervise the delegated persons or parties (to ensure the rights, safety and well-
being of the participants and data reliability)
• Ensure that delegated staff are appropriately qualified
• Maintain a record of the delegated staff
• Document agreements made by the investigator/institution with service
providers for trial related activities
• Permit monitoring and auditing by the sponsor and inspection by the appropriate
regulatory authority(ies)
2.4 Communication with IRB/IEC

• Before initiating a trial, the investigator/institution should have a documented

and dated approval from the IRB/IEC (for trial protocol, informed consent,
participant recruitment procedures (e.g., advertisements) and other information
to be provided to participants)
• Provide all updates to the Investigator’s Brochure and participant information, if
any
• Submit documented summaries of the trial status
• Communicate any changes that can significantly affect the conduct of the trial
and/or increase the risk to participants
2.5 Compliance with Protocol

• Comply with protocol, GCP and applicable regulatory requirements

• Document all protocol deviations
• In case of deviations undertaken to eliminate immediate hazard to trial
participants - inform sponsor, IRB/IEC and/or regulatory authorities
• Report information on the immediate hazard, the implemented change and the
subsequent proposed protocol amendment IRB/IEC and/or regulatory
authorities
2.6 Premature Termination or Suspension of a
Trial

• Promptly inform trial participants Regulatory authority

• Assure appropriate therapy and follow-up
for the participants

Investigator

Sponsor IRB/IEC
2.7 Participant Medical Care and Safety
Reporting

2.7.1 Medical Care of Trial Participants

 A qualified physician/dentist/other qualified healthcare professionals have the
overall responsibility for trial-related medical care and decisions
 Ensure that adequate medical care is provided to a participant for any adverse
events, related to the trial
 Inform a participant when medical care is needed for intercurrent illness(es) of
which the investigator becomes aware
 Inform the participant’s primary physician about the participant’s involvement
in the trial if he/she agrees
2.7 Participant Medical Care and Safety
Reporting

2.7.2 Safety Reporting

• Report adverse events and/or laboratory abnormalities to sponsor
• All serious adverse events (SAEs) should be reported immediately to the
sponsor
• For reported deaths, the investigator should supply the sponsor, the IRB/IEC
and, where applicable, the regulatory authority with any additional requested
information (e.g., autopsy reports and terminal medical reports) when they
become available
2.8 Informed Consent of Trial
Participants

1. Comply with the applicable regulatory requirement(s), GCP and the Declaration of
Helsinki
• Prior to enrolling participants, the investigator should have the IRB/IEC’s
documented approval/favourable opinion of the informed consent materials
and process
• Information should be clear and concise, in simple language
• Mention objectives of the trial, alternative treatments, the potential benefits
and risks, rights and obligations, compensation, duration of participation,
point of contact etc.
• Varied approaches may be used in the informed consent process - e.g., text,
images, videos
• Obtaining consent remotely may be considered where appropriate
2.8 Informed Consent of Trial
Participants

2. New information - to be duly informed to the participant or LAR in a timely

manner
3. Neither the investigator nor the investigator site staff should coerce or unduly
influence a participant
4. The informed consent process should be conducted by the investigator or other
investigator site staff delegated by the investigator
5. If the participant is unable to provide consent themselves, the participant’s LAR
should provide their consent on behalf of the participant
6. Information provided should be relevant, clear, simple, concise and
understandable to the participant/LAR/impartial witness
2.8 Informed Consent of Trial
Participants

6. Provide ample time and opportunity to enquire about trial details and to
decide whether or not to participate in the trial. Questions about the trial should
be answered to the satisfaction of the participant /LAR
7. Signature and date – participant/LAR/impartial witness, the investigator or
delegated investigator site staff who conducted the informed consent discussion.
8. Emergency situations –
• Participant consent not possible – LAR
• LAR not available - as per protocol
• Participant/LAR should be informed about the trial as soon as possible,
and consent as appropriate should be requested
2.8 Informed Consent of Trial
Participants

9. Impartial Witness – in case participant and LAR are unable to read

10. Minors
• age-appropriate assent information should be provided and discussed with
the minor
• assent from the minor should be obtained as appropriate
2.9 End of Participation in a Clinical Trial

• When a participant decides to stop treatment with the investigational product,

stop trial visits or completely withdraw from a trial, the investigator should
follow the protocol and other sponsor instructions to determine appropriate
follow-up measures
• Make a reasonable effort to ascertain the reason(s), while fully respecting the
participant’s rights
2.10 Investigational Product Management

• Responsibility for investigational product(s) accountability rests with the

investigator/institution
• Maintain records of product’s delivery, inventory, use, return, destruction or
alternative disposition of unused product(s)
• Should be stored as specified by the sponsor
• Should be used only in accordance with the approved protocol
• Investigator should explain the correct use of the investigational product(s) to
each participant
2.11 Randomisation Procedures and
Unblinding

• Follow the trial’s randomisation procedures

• In the case of an investigator-blinded trial, ensure that the identification
code is broken only in accordance with protocol
• In the case of an emergency, to protect patient safety, the investigator
should be prepared and capable to perform unblinding without undue
delay and hinderance
• The investigator should promptly document and explain to the sponsor
any premature unblinding (e.g., accidental unblinding, emergency
unblinding to protect trial participant, unblinding due to an SAE)
2.12 Records

• Ensure integrity of data

• Maintain source records – changes should not obscure original entry, should be
traceable (audit trail)
• Timely review of records
• Ensure the accuracy, completeness, legibility and timeliness of the data reported
to the sponsor
• Implement appropriate measures to protect privacy and confidentiality of
personal information of participants; data reported to the sponsor should be
identified by an unambiguous participant code
• The investigator/institution should have control of all essential records
generated by the investigator/institution before, during and after the trial
2.12 Records

• For computerized systems:

• Ensure that appropriate individuals have secure and attributable access
• Where equipment for data acquisition is provided to trial participants by the
investigator, ensure that traceability is maintained and participants are
provided with appropriate training
2.12 Records

• Retain essential records for the required retention period or until the sponsor
informs the investigator/institution that these records are no longer needed,
whichever is the longer
• Upon request of the monitor, auditor, IRB/IEC or regulatory authority, the
investigator/institution should make available for direct access all requested
trial- related records
2.13 Clinical Trial/Study Reports

• 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, if applicable, the regulatory authority(ies)
 https://youtu.be/YXrfW8a3k7E