The document outlines the roles and responsibilities of Clinical Research Associates (CRAs) in monitoring clinical trials, including types of monitoring such as on-site and remote. It details the monitoring process, from pre-study visits to site closure and emphasizes the importance of ensuring subject safety and data integrity. CRAs require at least a bachelor's degree, travel for work, and often receive higher remuneration than Clinical Research Coordinators (CRCs).

1. CLINICAL
REASEARCH
ASSOCIATE(CRA)

2. Introduction
Types of
monitoring
Monitoring
process
Responsibilities
of Monitor

3. Sponsor Investigator
Monitor
Monitor often called as CLINICAL MONITOR or
STUDY MONITOR

4. CRA stands for Clinical research associate
monitors
TRIAL ACTIVITIES
CRA
based at
Research sites
Visit sites
on certain
intervals
Sponsor’s place
(In-house CRO)
Home (Home
based CRAs)

5. Appointed by
Sponsor
Visits
Research site
MONITOR

6. • On-site
monitoring
• Remote
Monitoring
Monitor will visit
the hospital to do
the monitoring
Monitor does not
need to visit the
site, monitoring can
be done at home
and virtually.

7. 1
• Creation of monitoring plan
2
• Conducting monitoring
3
• Providing monitoring report
• It consists of 3 phases

8. Recruiting Investigators
Pre-Study Visits
Site Initiation Visits
Routine Monitoring Visits
Site Close out Visits
Feasibility of trial

9. Monitor
Reviews
Documentation
Source data verification
Monitor

10. CRA
Ensure
Investigator
s provided
with
current IB
Perform
Investigational
product
accountability
Assure the
protection of
rights, safety
and well-
being of
subjects
Ensures
scientific
integrity of
data
collected is
protected
and verified
Reviews
CRFs
Checks
clinical site
activities
Communicates
with CRCs

11. Pre Study Visit
 Conducted at a potential research site.
 Assess the investigator’s experience, staff, facility and
potential patient population.
 Introduce the study and obligations to the potential
investigator and staff.
Site Initiation Visit
 Conducted at a confirmed research site.
 Verify the confirmed Investigator's experience, staff, facility
and potential patient population.
 Detail the study and obligations to the investigator and
staff.
 Collect all essential documents before this visit.

12. Site Close out Visit:
Close out visit is conducted when-
 Study is complete and finished.
 Enrollment has stopped.
 All subjects have completed their study related
activities.
 Data are complete and correct.
 Final IP accountability is done.

13. CRA
JOB
Needs education of at least
a bachelor’s degree or
equivalent degree
Need some work experience
Need to travel
Remuneration more than CRC

14.  https://www.slideshare.net/wwwCLINIINDIAcom/cra
-monitor-roles-and-responsibilities
 https://www.youtube.com/watch?v=orT4gxDFRRI&t=
7s
 https://www.fda.gov/files/drugs/published/E6%28R2
%29-Good-Clinical-Practice--Integrated-Addendum-
to-ICH-E6%28R1%29.pdf

15. THANK YOU
CH.Roshini-003/o122
chepuriroshini2@gmail.com