KEY KEY STAKEHOLDERSTAKEHOLDERS IN CLINICAL S IN CLINICAL

RESEARCHRESEARCH

By SUCHISMITA BANIKStudent ID: 3797 Cliniminds Mumbai

Study Sponsors Investigators

& Site

personnel

Monit

ors

IRB / IEC

Study

subjects

Regu

lator

s (C

DSCO

)

KEY STAKEHOLDERS

Study design

Design study doc.

Investigator selection

Ethics committee review

Approval letter

Statistical review

Data Management

Site initiation

Monitoring

Follow up visit

Final report

Notification to regulatory authority

End of trial

Patient enrollment

Investigator meeting

OVERVIEW OF CLINICAL TRIAL

SPONSOR

Sponsor outsource part or all of the responsibilities to the

SPONSOR’S RESPONSIBILITIES

Sponsor Investigator

Clinical Trial

chooses

monitors conducts

SPONSOR’S RESPONSIBILITIES

Sponsor

CRO

InvestigatorIndependent Ethics

Committee (IEC)

AGREEMENT

NOTE: Sponsor signs FDA 1571

Form

INVESTIGATOR

INVESTIGATOR’S RESPONSIBILITIES

INVESTIGATOR’S RESPONSIBILITIES

Signed agreement between involved parties

CRO SPONSOR

AUTHORITIES (if reqd.)

INVESTIGATOR

NOTE: Investigator signs

FDA 1572 Form

• Principal communication link between the Sponsor & Investigator

• Selection and qualification of Monitorso Appointed by Sponsoro 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

COMPOSITION:• 8-12 members form IEC.• Minimum 5 persons required to form the

QuorumBASIC LAYOUT:1.Chairperson (from outside the Institution)2.1-2 clinicians from various Institute3.1-2 persons from basic medical sciences4.1 retired judge5.1 social scientist6.1 Philosopher/Ethicist/Theologist7.1 lay person8.1 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

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

Subject Recruitment

Eligible Patients

Inclusion criteria

Exclusion criteriaEg: Age-18-65

yrsEg: 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

Voluntary participation

Duration of trial

Insurance & compensation

Name and phone no. of

contact personAlternative Procedures

Rights & confidentiality

Purposes

RisksBenefits

Basic Elements of ICF

STUDY SUBJECTS [INFORMED CONSENT FORM (ICF)]

Termination Cost

Consequences of withdrawal

Language

Additional Elements of ICF

STUDY SUBJECTS [INFORMED CONSENT FORM (ICF)]

REGULATORY AUTHORITIES

US

* Regulatory Agency regulates-1.Market Authorization of new drugs2.Clinical Trial Standards

REGULATORY AGENCIES IN INDIA

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

REGULATORY AUTHORITIES REVIEW