It is only for study purpose,not for sale

1. CLINICAL TRIAL PROCESS

2. CRO/BD
SPONSOR
PROTOCOL & SYNOPSIS
YES NO (ONLY DRUG
INFORMATION)
MEDICAL WRITING
TEAM DEVELOP
PROTOCOL
REVIEWED BY
SPONSOR,PI,HEAD(QA
&BA)
ADDITION OR EDIT
FINALISED
IEC/IRB SUBMISSION
IF A DRUG >4 YEARS IN
MARKET
IEC-NOTIFIACTION TO
DCGI
IF A DRUG <4 YEARS
APPROVAL FROM DCGI

3. CLINICAL TRIAL PROCESS
SITE IDENTIFICATION
MAIL TO PI
CALL TO PI
REFFERED PI
SITE QUALIFICATION
BASED ON PROTOCOL
SFQ OF STUDY
ACCREDIATION
SITE SELECTION
PATIENT POOL
ALL ACTIVITY SOP
FACILITY
(EQUIPMENTS,STORAGE)
& MAN POWER
SITE INITIATION
PI,CO-I,CRC,STAFF-CV
PROTOCOL TRAINING
SITE AUDIT
SITE MONITORING
SOURCE DOCUMENT
ACTIVITY ACCORDING TO
PROTOCOL,SOP
SITE CLOSE OUT
COMPLETE SOURCE DATA
ERRORS
CLOSE OUT

4. CLINICAL TRIAL
PROCESS
SUBJECT
SCREENING
DAY-0 SUBJECT
CHECK IN
DAY-1 DOSING
DAY-2 CHECK
OUT

5. DAY-0 SUBJECT CHECK IN
REPORT OF VOLUNTEER
EXPLAIN DETAILS TO VOLUNTEER(DRUG
INFORMATION,ADR,SYNOPSIS,BLOOD
VOLUME,STUDY DURATION,SAFTEY
COSENT,STUDY
DETAILS,PROCEDURE,HOSPITAL
DETAILS) AV RECORDING
OBTAIN SIGNED ICF FROM
SUBJECT/VOLUNTEER
ALLOT SUBJECT IDENTIFICATION
NUMBER
ISSUE CRF AND CHECK IN
TEST(ABT,UDAT,CLINICAL
EXAMINATION,VITALS)
FASTING FOR 11 HRS

6. DAY-1 DOSING
PREDOSE SAMPLE
INSERT CANNULAE ,
BLOOD WITHDRAWAL
IF ANYTHING WRONG
REPORT AS MEDICAL
EVENT
POST DOSING
POSTURE
RESTRICTION,SAMPLE
WITHDRAWAL ,
LUNCH,SNACKS,DINNER

7. DAY-3 CHECK
OUT
AMBULATORY
SAFETY SAMPLE
AND
EVALUATION
REPORT IF ANY
ADVERSE EVENT

8. Responsibility and Maintenance
Tasks Director BD MD Compliance Head Project
Manager
Medical Writer PI CRC Study Team Pharmacist Nurse Phlebotomy
Project Proposal R&A I
Protocol Writing C I C R A A
EC approval I I I R A A
Site Identification,
Selection, Initiation
C I R R C A A
Patient Screening &
Selection
R R&A A
AE/SAE reporting I I R R&A A A
Laboratory Audit &
selection
I R&A C A
Pharmacy I R A
Study Execution I R R R&A A A A A A
Phlebotomy R R&A A
Vitals R R&A A A
Study Monitoring R&A A A
Study Completion I I R R R A A
Review I R&A R A A
Biological Waste disposal R&A R R A
Sample Storage and
Transfer
R R&A A A
Maintenance of all
Equipment’s
I R R R A A
Room Temp. monitoring R R A A
Documentation R R R A A
Communication I R R A
Archiving R&A R R A A
RACI Matrix
Responsibility
Accountability
Consulted
Informed

9. THANK YOU