RESPONSIBITIES OF STAKEHOLDERS

1. BY: ARIFA KHAN
RESPONSIBILITIES OF
STAKEHOLDER

2. STAKEHOLDER
S IN THE
CLINICAL
TRIALS
SPONSOR
INVESTIGATOR
STUDY SUBJECT
PATIENT
MONITOR
ETHICS
COMMITTEE
REGULATORY
AUTHOURITY
STAKEHOLDERS

3. RESPONSIBILITIES OF SPONSORS
Quality assurance and Quality control
Outsourcing to CROs
Designation of medical expertise
Trial design
Trial management ,Data and record
handling
Investigator selection
Compensation to subject and
investigators
Confirmation of review by IRB/IEC

4. RESPONSIBILITIES OF SPONSORs
Information on Investigational product {I.P}
Manufacturing, packaging, labeling & coding
IP
Record access
Safety information
Non compliance
Premature termination or suspension of a trial
Supplying and handling of IP
Study report

5. RESPONSIBILITIES OF INVESTIGATORS
SUBJECT
RECRUITMENT
RECORDS
REPORTS
TRIAL
CONDUCT
QUALIFIED
STAFF
INVESTIGATIONAL
PRODUCT
MEDICAL
CARE
PROTOCOL
COMPLIANCE
IRB/IE
C

6. Investigators qualifications
Adequacy of resources
Medical care of study participants
Communication with IRB /IEC
Compliance with the protocol
Investigational product care
Randomization &unbinding
The informed consent
RESPONSIBILITIES :INVESTIGATORS

7. Record and report
Progress report
Safety reporting
Stopping or suspending a study
Final report by investigator
RESPONSIBLITIES OF INVESTIGATORS

8. MONITORS
• Principal communication link
between the sponsor
&investigator
 Selection and qualification of
monitor
 Appointment by sponsor
 Scientific &clinical knowledge
to monitor the trail
 Purpose : securing
compliance
 Extent &nature of monitoring
: determined by sponsor
onsite monitoring
 Procedure
 Monitors responsibilities
 Monitoring report

9. INDEPENDENT ETHICS COMMITTEE(IEC)
An ethics committee is committee formally designated
to review and approve the initiation of clinical research
study involving human participants and to provide
continuing review of the research study.
INSTITUTIONAL REVIEW BOARD= ETHICS COMMITTEE

10. 8-12 members from IEC
Minimum 5 person required to form QUORUM
COMPOSITION OF IEC
Chairperson
(from outside
the
institution)
1-2 Clinician
from various
institute
1-2 Person
from basic
medical
science
1 Legal
expert or
retired judge
1 Social
scientist/
representative
of non
governmental
voluntary
agency
1 Ethicist
1 Lay person
Member-
secretary

11.  Safeguard the rights, safety and wellbeing of all
subjects.
 Obtain documents (as per ICH-GCP)and as per
schedule Y.
 Review clinical trial with in reasonable time .
 Continuing review of each on going trial atleast
once in a year.
 Review proposed research at convened meetings.
 Implement informed consent requirement.
Request additional information .
Amount and method payment.
Documentation and other written information.
RESPONSIBILITIES OF IEC

12. STUDY SUBJECTS
Subject Recruitment
Eligible
patients
Inclusion criteria
Eg : age 18-65
Exclusion criteria
Eg : age below 18
yr above 65

13. STUDY SUBJECT (INFORMED CONSENT FORM)
Name and phone no of contact person
Rights and
confidentiality
Risks
Benefits
Insurance and compensation
Voluntary participation
Duration of trial purpose

14. Termination
Consequences of
withdrawal
Language
ADDITIONAL ELEMENTS OF ICF

15. REGULATORY AGENCIES IN INDIA

16. CT application by sponsor
/investigator/hospitals to CDSCO
CT documents sent to NDAC
Review by CDSCO &NDAC
Meeting of sponsor /investigator with
CDSCO &NDAC (including CT
presentation & Q&A session
Approval / Rejection of CT
REGULATORY AUTHORITIES REVIEW

17. Thank you