2. OVERVIEW OF CLINICAL TRIAL
Research studies involving patients or
populations at risk for disease.
Designed in a scientific manner and
conform to ethical standards.
May be directed at questions of
causation, prevention, early detection
or treatment.
3. IMPORTANCES OF CLINICAL TRIAL
To increase knowledge.
To provide “evidence-based” patient care or
prevention of disease.
To improve the quality of care.
Quality care to in trial as well as out patients,(i.e.
Supportive care)
4. MEMBERS OF RESEARCH TEAM
Principal
Investigator
Regulatory Co and
Bodies. Associate
Investigator
Institutional Clinical
Review Board Research
{IRB} Coordinator
Data Manager
Patients and Clinical
Pharmacist
Statistician
5. Investigator
An investigator -a person who is responsible for
conducting clinical trial at the trail site.
If a trial is conducted by a team of individuals ,
then the investigator is the responsible leader of
the team and called the principal investigator.
6. RESPONSIBILITY OF AN INVESTIGATOR
Investigator should qualified ,educated, trained, experienced.
Show all the up-to-date document to IRB /IEC.
Familiar with investigational products and their use.
Aware and comply GCP and applied regulatory requirements.
Permits:- Monitoring, Auditing ,Inspection.
Make appropriate list of :- Qualified persons to whom he has delegated
significant trial related duties.
7. RESPONSIBILITY OF AN INVESTIGATOR
Adequate Resources
To ensure that all
the person who
To arrange
assisting with the
adequate Having sufficient He should recruit
trial are informed
numbers of time to conduct required number
about “protocol,
qualified staff and and complete the and suitable
investigational
facilities for the trial. subject.
product and trial
trial.
related duties and
functions”.
8. RESPONSIBILITY OF AN INVESTIGATOR
Medical care of trial subject :-
Responsible for all trial related medical decision.
Ensure that adequate medical care will provided for any ADRs during trial.
Informed the subjects about all the risk and health problem which can
occurred during the trial before they join the trial.
If subject having some primary physician and he want to inform them, its
investigators duty to inform them.
9. RESPONSIBILITY OF AN INVESTIGATOR
IRB/IEC Approval:-
IRB/IEC Be familiar
with any Drug Human
approval of
national law approval Inform any tissues
protocol
that may and deviation Funding (storage,
and
impact importation from the policies and use, transfer
informed
study design approved to another
consent of drug the rules.
or institution
before {where, protocol.
or other
initiation of Participatio- how, cost}. country).
study. n.
10. RESPONSIBILITY OF AN INVESTIGATOR
Investigational Product
Packed, labeled and
It should be handled in appropriate manner.
stored in correct form
Include dates, The doses record
quantities, batch/serial should be
Correct record
number, unique code maintain(quantity,
numbers. date, time etc.).
11. RESPONSIBILITY OF AN INVESTIGATOR
Informed consent of trial subject
Obtain informed consent from patients or parents of minor patients
• Prior to starting protocol.
• Prior to randomizing patient if the study is a randomized trial.
On going and interactive process between the research team and patient.
• To ensure patient understand the study.
• To ensure patient understands what is required to participate in the
study.
12. RESPONSIBILITY OF AN INVESTIGATOR
Information to be conveyed:-
Participation is voluntary.
Information about the patient’s disease.
Rationale for specific therapy planned in trial.
Description of the “research” objectives.
Differentiation between “research elements” and “standard care”.
Subjects “required involvement”:-
Duration of participation.
Frequency of hospitalization, out patient visits during trial.
Frequency of visits after trial.
Alternative approaches to treatment ( standard treatment, no treatment if no
alternatives).
Risk or discomforts (side effects of treatment and procedures).
13. RESPONSIBILITY OF AN INVESTIGATOR
State how subject confidentiality will be maintained.
• Provisions for research related injuries and compensation for disability or
death.
Cost to the patient as a result of participation.
• Contact details for problems or questions- 1.Investigator,2.Patient advocate.
Notify IRB/Sponsor of any issues that pose a threat to the safety and well being
of the subject.
Submit any change (amendments)made to the protocol to the IRB for approval.
Provide information about protocol progress to the IRB on an annual basis
(Annual continuing reviews).
14. RESPONSIBILITY OF AN INVESTIGATOR
Quality and accuracy of the
data recorded on study case
report forms.
Comply with all procedure
specified in protocol in
accordance with GCP.
Make data available for
external monitors(if
Records and applicable).
Reports:-
Record all data pertinent to
the study.
Perform data
verification,(match case
report forms with source
data) .
Maintain all study
documentation.
15. RESPONSIBILITY OF AN INVESTIGATOR
Provide all required report
to Sponsor, IRB/IEC and
Completion of the trial he
should inform institution
the Regulatory authorities, FINAL REPORT
with the summery of the
trial.
16. Conclusions
right, safety and well-being of subjects are
PROTECTED.
Data is ACCURATE.
Reported results are CREDIBLE
PI should strive to meet the high standards of GCP in
order to provide public assurance that the:-
The Principal Investigator(PI) is ultimately
accountable and responsible for conducting a clinical
trial.
A “Research team” approach is ideal
Clinical trials imply a disciplined approach to the care
of the patients enrolled on the studies.
