The document outlines the responsibilities of clinical trial investigators, including their qualifications, resource management, medical care for subjects, compliance with protocols, and safety reporting. Investigators must ensure informed consent, maintain accurate records, and communicate with regulatory bodies throughout the trial process. Additionally, it emphasizes the importance of adhering to good clinical practice (GCP) and regulatory requirements while protecting the rights and well-being of participants.

1. INVESTIGATOR’S
RESPONSIBILITIES
Bhavya RajanM.tech PruthvirajPharmD TejaswiniBPharm
Presented by
ClinoSol research Pvt.Ltd
Education and research center

2. 1. Investigator’s Qualifications and Agreements
2. Adequate Resources
3. Medical Care of Trial Subjects
4. Communication with IRB/IEC
5. Compliance with Protocol
6. Investigational Product(s)
7. Randomization Procedures and Unblinding
8. Informed Consent of Trial Subjects
9. Records and Reports
10.Progress Reports
11.Safety Reporting
12.Premature Termination or Suspension of a Trial
13.Final Report(s) by Investigator
CONTENT

3. Who can be an investigator in clinical trial ?
An investigator…
❑ is a qualified physician who is responsible for all trial-related medical decisions
❑ must have suitable education, training and experience in the field being researched
and also have a knowledge of GCP and applicable regulatory requirements
❑ should permit monitoring and auditing by the sponsor, and inspection by the
appropriate regulatory authority(ies)
❑ 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 the principal Investigator.
❑ Sub-Investigator: a member of Clinical trial team, designated and supervised by
principal Investigator to perform trial related duties and functions.

4. INVESTIGATOR’S
QUALIFICATIONS
AND
AGREEMENTS

5. INVESTIGATOR’S QUALIFICATIONS AND AGREEMENTS
should be qualified by
education, training, and
experience
meet all the qualifications
specified by the applicable
regulatory requirement(s)
with evidence
Familiar with
o Protocol,
o Investigational Brochure
o Investigational Product
Aware of and comply .with
GCP’s and applicable
regulatory requirements.
permit monitoring and
auditing by the sponsor, and
inspection by the appropriate
regulatory authority(ies)
List of Qualified persons
who are delegated trial
related duties.

6. ADEQUATE RESOURCES

7. Adequate Resources
Recruit number of suitable
subjects within the agreed
recruitment period
Having sufficient time to
conduct and complete
within the agreed trial
period
Arrange adequate number
of qualified staff and
facilities for the duration of
the trial to conduct the trial
properly and safely
Ensure that all persons
assisting with the trial are
adequately informed about
the protocol, investigational
products and their trial
related duties and function

8. MEDICAL CARE OF
TRIAL SUBJECTS

9. MEDICAL CARE OF TRIAL SUBJECTS
Ensure that adequate medical care is provided to a
subject for any adverse events, including clinically
significant laboratory values
Inform a subject when medical care is needed for
intercurrent illness(es)
Inform the subject’s primary physician about the
subject’s participation
Although a subject is not obliged to give his/her
reason(s) for withdrawing prematurely from a trial, the
investigator should make a reasonable effort to
ascertain the reason(s), while fully respecting the
subject's rights.

10. COMMUNICATION WITH
IRB/IEC

11. COMMUNICATION WITH IRB/IEC
Before initiating a trial investigator should have: written and dated
approval/favorable opinion from the IRB/IEC for the
Trial protocol
written informed
consent form
consent form
updates
subject recruitment procedures
& other written information to
be provided to subjects
Investigator should provide current and updated { if made } copy of investigator
brochure to IRB/IEC
During the trial the Investigator should provide to the IRB/IEC all documents
subject to review.

12. COMPLIANCE
WITH
PROTOCOL

13. COMPLIANCE WITH PROTOCOL
Conduct the trial in compliance with the protocol agreed by sponsor and Regulatory
authorities and sign the protocol, or an alternative contract, to confirm agreement.
Should not implement any deviation from protocol without agreement by the sponsor
and prior review.
EXCEPT…. In emergency where necessary to eliminate immediate hazard to trial
subjects or if change involves only logistical or administrative aspect of the trial
( eg. Change of monitor or change of telephone Numbers)
Person designated by the Investigator, should document and explain any deviation
from the approved protocol.
As soon as possible, the implemented deviation or change, the reasons for it, and, if
appropriate, the proposed Protocol amendment(s) should be submitted to sponsor,
IRB/IEC and regulatory authorities

14. INVESTIGATIONAL PRODUCT(S)

15. INVESTIGATIONAL PRODUCT(S)
MAINTAIN RECORDS
Should maintain records of the
product's
✓ delivery to the trial site
✓ inventory at the site
✓ use by each subject
✓ the return to the sponsor
or
✓ alternative disposition of
unused product(s).
STORAGE
Should be stored as specified by
the sponsor and in accordance
with applicable regulatory
requirement(s).
The investigator, or a person designated
by the investigator, should explain the
correct use of the investigational
product(s) to each subject and should
check, at intervals appropriate for the
trial, that each subject is following the
instructions properly.
ENSURE
The investigator should ensure
that the investigational product(s)
are used only in accordance with
the approved protocol.
EXPLAIN / CHECKING

16. RANDOMIZATION PROCEDURES
AND UNBLINDING

17. RANDOMIZATION PROCEDURES AND UNBLINDING
❑ The investigator should follow the trial's randomization
procedures, if any, and should ensure that the code is broken
only in accordance with the protocol.
❑ If the trial is blinded, the investigator should promptly
document and explain to the sponsor any premature unblinding
(e.g., accidental unblinding, unblinding due to a serious adverse
event) of the investigational product(s)

18. INFORMED CONSENT OF TRIAL
SUBJECTS

19. INFORMED CONSENT OF TRIAL SUBJECTS
While obtaining and documenting Informed consent,
Investigator must -
✓Comply with Regulatory Requirements
✓Adhere to GCP
✓Ethical principles from Declaration of Helsinki
Prior to trial, investigator should have IRB/IEC’s
written approval of-
✓Written Informed consent form/ revised ICF
✓For any other written information shared with
subjects
✓ Communication of revised ICF should
be documented
✓ No one should unduly force subject
for participation
✓ Ample time for enquiring about trial &
all questions should be
answered

20. -
Language
•Non- technical
•that appears to waive legal rights of subject or
release organizations/ people involved in CT
from liability of negligence should NOT be
used
Legally Acceptable
Representative(LAR)
•Incase, subject is unable to give informed
consent, investigator informs all the aspects
of trial to LAR
•Eg. Minors, Patient with dementia etc
Impartial Witness
•Incase, Subject/LAR unable to read
•Signs ICF after Subject/LAR has given oral
consent and if possible personally signed and
dated
•By signing ICF, Impartial witness attests that
all information was accurately explained &
understood by Subject/LAR
✓ Prior to participation, Subject/LAR should
receive a copy of ICF; any other written
Information
✓ and during participation copy of updated
ICF ; any amendments in written
information provided
✓ Subjects who are enrolled after consent
of LAR, should be informed about trial to
extent of their understanding
ICF continued..

21. ICF continued..

22. ICF continued..

23. - Non-therapeutic trial should be conducted only in subjects who can personally give consent, except in
these situations.
- Also, subjects should be closely monitored and withdrawn if they appear unduly distressed.
When objectives of trial cannot be met with such subjects
Foreseeable risks in subject are low
Negative impact on subjects well being is minimized or low
Trial is not prohibited by law
Approval of IRB/IEC is expressly sought for inclusion of such subjects

24. Emergency
situation, and
Subject’s
consent not
possible
LAR present Take consent
LAR absent
Measures prescribed in Protocol
Documented approval of IRB/IEC to
protect the rights, safety & well being of
patients
Ensure Compliance with regulatory
requirements
Inform Subject/ LAR as soon as possible
ICF continued..

25. RECORDS
AND
REPORTS

26. RECORDS AND REPORTS
The source documents and trial
records should be maintained
with adequacy and accuracy by
the investigator
Data reported to the sponsor
in the CRF, that are derived
from source documents,
should be consistent with the
source documents
Any change or correction to a
CRF should be dated, Initialed
and explained and should not
obscure the original entry(i.e.
Audit trail should be
maintained)
The Investigator should maintain
the trail documents as specified in
the Essential documents for the
conduct of a clinical trail.
Measures should be taken to
prevent accidental or premature
destruction of these documents
The financial aspects of the
trail should be documented in
agreement with the sponser
and Investigator.

27. PROGRESS
REPORTS

28. PROGRESS REPORTS
Status Report
Submit written summaries of
the trial status to the
IRB/IEC annually, or more
frequently, if requested by
the IRB/IEC.
Risk Report
Should promptly provide written reports to
the sponsor, the IRB/IEC and, where
applicable, the institution on any changes
significantly affecting the conduct of the trial,
and/or increasing the risk to subjects.

29. SAFETY
REPORTING

30. SAFETY REPORTING
All serious adverse events (SAEs)
should be reported immediately to
the sponsor
EXCEPT
for those SAEs that the protocol or
other document (e.g., Investigator's
Brochure)identifies as not needing
immediate reporting.
The immediate and follow-up
reports should identify subjects
by unique code numbers
assigned to the trial subjects.
Should follow regulatory requirements
should report unexpected SAE’s to
regulatory authorities
Identified abnormalities & SAE’s in the
protocol which are critical to safety
evaluations should be reported 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).

31. PREMATURE
TERMINATION
OR
SUSPENSION OF
A TRIAL

32. PREMATURE TERMINATION OR
SUSPENSION OF A TRIAL
If the investigator terminates
or suspends a trial without
prior agreement of the
sponsor
If the sponsor terminates or
suspends a trial
If the IRB/IEC terminates
or suspends its
approval/favourable opinion
of a trial
The investigator should inform the
institution where applicable, and the
investigator 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.
The investigator should promptly
inform the institution where
applicable and the investigator
should promptly
inform the IRB/IEC and provide
the IRB/IEC a detailed written
explanation of the
termination or suspension.
The investigator should inform
the institution where applicable
and the investigator should
promptly notify the sponsor and
provide the sponsor with
a detailed written explanation of
the termination or suspension.

33. FINAL
REPORT(S)
BY
INVESTIGATOR

34. FINAL REPORT(S) BY INVESTIGATOR
should inform the
institution
should provide the
IRB/IEC with a
summary of the
trial’s outcome
should provide the
regulatory
authority(ies) with
any reports required.
COMPLETION OF
TRIAL

35. REFERENCE

36. REFERENCE
❑ https://database.ich.org/sites/default/fil
es/E6_R2_Addendum.pdf