1. KEYKEY
STAKEHOLDERSSTAKEHOLDERS
IN CLINICALIN CLINICAL
RESEARCHRESEARCH
KEYKEY
STAKEHOLDERSSTAKEHOLDERS
IN CLINICALIN CLINICAL
RESEARCHRESEARCH
By SUCHISMITA BANIK
Student ID: 3797 Cliniminds Mumbai

2. Study Sponsors
Investigators&
Sitepersonnel
Monitors
IRB / IEC
Studysubjects
Regulators
(CDSCO)
KEY STAKEHOLDERS

3. Study designStudy design
Design study doc.Design study doc.
Investigator
selection
Investigator
selection
Ethics committee
review
Ethics committee
review
Approval letterApproval letter
Statistical reviewStatistical review
Data ManagementData Management
Site initiationSite initiation
MonitoringMonitoring
Follow up visitFollow up visit
Final reportFinal report
Notification to
regulatory
authority
Notification to
regulatory
authority
End of trialEnd of trial
Patient enrollmentPatient enrollment
Investigator
meeting
Investigator
meeting
OVERVIEW OF CLINICAL TRIAL

4. SPONSOR
Sponsor outsource part or all
of the responsibilities to the
SPONSOR’S RESPONSIBILITIES

5. SponsorSponsor InvestigatorInvestigator
Clinical TrialClinical Trial
chooses
monitors conducts
SPONSOR’S RESPONSIBILITIES
SponsorSponsor
CRO
Investigator
Independent Ethics
Committee (IEC)
AGREEMENT
NOTE: Sponsor signs
FDA 1571 Form

6. INVESTIGATOR
INVESTIGATOR’S RESPONSIBILITIES

7. INVESTIGATOR’S RESPONSIBILITIES
Signed agreement between involved parties
CRO SPONSOR
AUTHORITIES
(if reqd.)
INVESTIGATOR
NOTE: Investigator signs
FDA 1572 Form

8. • Principal communication link between the Sponsor
& Investigator
• Selection and qualification of Monitors
o Appointed by Sponsor
o Scientific & clinical knowledge to monitor the
trial
• Purpose: Securing compliance
• Extent & nature of monitoring: Determined by
Sponsor-on-site monitoring
• Procedures
• Monitors responsibilities
• Monitoring report
MONITORS

9. COMPOSITION:
• 8-12 members form IEC.
• Minimum 5 persons required to form the Quorum
BASIC LAYOUT:
1. Chairperson (from outside the Institution)
2. 1-2 clinicians from various Institute
3. 1-2 persons from basic medical sciences
4. 1 retired judge
5. 1 social scientist
6. 1 Philosopher/Ethicist/Theologist
7. 1 lay person
8. 1 member secretary
INDEPENDENT ETHICS COMMITTEE (IEC)
1. Safeguard the rights, safety and wellbeing of all
subjects
2. Obtain documents (as per ICH-GCP) and as per
schedule Y
3. Review clinical trial within reasonable time
4. Continuing review of each on-going trial atleast
once in a year
5. Review proposed research at convened meetings
1. Any unanticipated problems involving risks to
human subjects
2. Serious/continuous non-compliance with IRB
approval
3. Termination/suspension of IRB approval

10. INDEPENDENT ETHICS COMMITTEE (IEC)
• Risk to subjects minimized
• Risks to subjects reasonable w.r.t
anticipated benefits
• Subject selection equitable
• ICF to be taken from each subject(s)
or Subject’s LAR
• Adequate provision for monitoring
the data to ensure safety of subjects
• Adequate provision to protect privacy
of subjects and maintain
confidentiality of data

11. Subject Recruitment
Eligible Patients
Inclusion criteria Exclusion criteria
Eg: Age-18-65 yrs Eg: Age-below 18
yrs & above -65 yrs
Document Assent on
IRB approved assent
form
Assent verbally
obtained
Informal process
Children & ICF
Patient of 18 yrs give
Informed consent
STUDY SUBJECTS

12. Voluntary
participation
Duration of
trial
Insurance &
compensation
Name and phone
no. of contact
person
Alternative
Procedures
Rights &
confidentiality
Purposes
RisksBenefits
Basic Elements of ICF
STUDY SUBJECTS [INFORMED CONSENT FORM (ICF)]

13. Termination Cost
Consequences of
withdrawal
Language
Additional Elements of ICF
STUDY SUBJECTS [INFORMED CONSENT FORM (ICF)]

14. REGULATORY AUTHORITIES
US
* Regulatory Agency regulates-
1.Market Authorization of new drugs
2.Clinical Trial Standards

15. REGULATORY AGENCIES IN INDIA

16. Statement of specific principles on Research
using human participants in specific areas of
Biomedical Research
Statement of general principles on research
using human participants in Biomedical
Research.
REGULATORY AGENCY IN INDIA

17. REGULATORY AUTHORITIES REVIEW