The Check-in process for the Clinical Study at the CRO had issues, we call it opportunity for improvement, the Clinical Quality department decided to apply quality improvement tools to improve the process. The Process was mapped in entirety with the input from the representatives of the clinical team. Some critical areas were identified and SOP amendments, increase in the staffing etc were incorporated in the process to streamline it. Results were, improved check-in time for each study volunteer by about 15 minutes and this improved the morale of the staff, an increase in volunteer satisfaction was observed and the errors in the process was reduced by about 35% all this resulted in 20% reduction in cost for the study and more savings for the organization.

1. WELCOME
TEAM LAMBDA
Clinic Process
Flow

2. PROCESS MAPPING

3. What is a Process?
• Is a series of related activities that “flow”
through an organization
• Is not limited to a single function/area
• Activities or tasks that produce a specific
service or product for customers/clients
• Something which can be viewed from
beginning to end

4. What is Process Mapping?
• Process Mapping is a tool to understand, analyze &
document processes & activities in an organization
and help identify opportunities for improvement
• Process Map depicts the sequential steps involved in
converting a specific input to required output.

5. Why Map a Process?
• Pictures are worth 1000 words
• Visualizing processes makes the problem
clearer from the start
• Improves understanding the work process
(Resource and Staff allocation) & tracks work
flow
• Process improvement can be instituted
• Identify efficiency issues & where and how
systems can support these

6. "The first step in any organisation is to
draw a flow diagram to show how each
component depends on others. Then
everyone may understand what their job
is. If people do not see the process, they
cannot improve it."
William Edwards Deming
(1900-1993)

7. Symbols
Action/Process
Start or End
Decision
Flow
Direction
On Page
Connector
Off Page
Connector
Document
NO
YES

8. The Process Framework
Continuous Improvement
AS-IS
Design ►
Identify Best
Practices
TO-BE
Design ►
Analyze &
Evaluate ►
Implement
►
BPI BT
BPR

9. Steps
• Start with a high-level flow (Context Diagram) and then drop
to the next level of detail if necessary (i.e. sub processes)
• Define the beginning and end of each sub process (stay
focused)
• Define key inputs and outputs
• Walk through each key sub process step by step
• Don't waste time: If you get bogged down, take a break or
move on to another area
• Identify process and technology opportunities for
improvement as you go or at the end of each sub process
• Verify the accuracy of the flow

10. Process Selection
Mapping Process
Plan & Schedule
Resources
Select Technique
Individual
Interviews
Group
Mapping
As-is Process
Opportunities for
Improvement
To-be
Process
Continuous
Monitoring
Implement
Redesign

11. Study Check-in Process
Informed Consent
(Period 1 only)
Physical Examination
(As applicable)
Compliance, Bag
Search & Vital Signs
Subject ID Verification
Photo ID check
(1a)
Preprinted wrist
band checked and
applied to the
hand of the
Subject.
(1d)
Subject screening
File checked with
the Wrist Band
(2a)
Physician
completes physical
examination forms
(2b)
PI renders subject
eligible for the
study
(2c)
Restricted items
confiscated,
Laptop camera
taped
(3c)
Breathalyzer
(Alcohol)
(3e)
Urine Sample
collection
Nicotine + Drugs
of abuse
(3f)
Beta- HCG for all
female subjects
(3g1)
PI Signs the ICF
document
(4d)
Ensure that they
have understood
while they consent
for study
(4b)
Subjects Sign the
ICF document
(4c)
Subjects are read
the ICF by the RN
/ Designate
(4a)
Click to go
to page 2
Copy of ICF & Clinic
rules distributed to
subjects
(4e)
Compliance
Questionnaire
(3a)
Click to
go to
page 1
Other applicable
tests
(3g2)
Subject Signs the
Check in Record
(1b)
Signature
Verification with
Records
(1c)
Detailed body &
Bag Search
(3d)
Vital Signs Check
(3b)
CRITICAL
PROCESS
(Amend SOP &
Form)
CRITICAL
PROCESS
(Needs more
dedicated Staff)
CRITICAL
PROCESS
SOP needs to be
followed and Strict
monitoring in place
CRITICAL
PROCESS
Restrictions to be
observed more
stringent

12. Post Check-in Clinic Process
Dosing day activities
*
Check - Out
*
Post-dosing activities
*
Pre-dosing day
activities
*
Overnight Pre-dose
activities
*
Check-in
Meal
(5a)
Sleep
(5b)
Fluid Preparation
(5c)
Pre-dose
blood
collection and
catheter
insertion
(6d)
Hands Mouth
Check
(Not for
Injectibles)
(7b)
Subjects
follow posture
restrictions
(7c)
Scheduled
Blood Draws
as per
protocol
(8a)
Scheduled
Vital checks,
ECG,
Glucose &
HSM.
(8b)
Meals as per
protocol
(8c)
Pre-dose
Vitals Check
& HSM
(6a)
Suitablity for
Dosing
(6c)
End of Restrictions
(7d)
Sample
Processing
(8a1)
HSM, Vitals,
ECG,
Biochemistry,
Hematology,
Urine
(9a)
Subject Checks
Out
(9e)
Subjects might
return for blood
draws as per study
requirement
Blood Draw &
catheter removal
(9b)
Click to go
to Page 3
Beta-HCG
result report
collection
(5d)
Restrictions
Start
(6b)
High Fat Breakfast
(if applicable)
(6e)
Return
Confiscated Items
to subjects
(9c)
Wallet card,
Snack &
Compensation
(9d)
Drug
Administration
(7a)
*Continuous AE Monitoring & Record
Release of SB’s
after PI
assessment
(If Applicable)
Results out of
Range PI should
be consulted
before exit.

13. Additional Process for Return Blood Draws
Return Blood Draws
Subjects
attend the
Clinic for
Return Blood
Draw
(10a)
Return Blood
Draw Card
given to the
subject
(10b1)
Staff verifies
ID and Signs
subject in
(10b)
Return Blood
Draw
Compliance
(10d)
Staff Checks
the ID and
the Return
Blood Draw
card
(10e)
Sample
Processing
(10f1)
Subject Leaves the Clinic with
further instructions
(10h)
Click to go
to page 2
Subject
Compensation
(If Required)
(10g)
Click to go
to page 1
Signatures
verified with
records
(10c)
Protocol required
activities e.g.
Vitals and Blood
Draw
(10f)

14. DYNAMIC CLINIC TEAM

15. DO map the process as it
actually happens
DO think about the process
across the entire
organisation
DO talk to the other people
who are involved in the
process
DO define the beginning and
end of the process before
you start
DO the process map at a
high level
DO ask questions
DON’T map the process as you
think it happens or as you think it
ought to happen
DON’T restrict your process map to
the activities in your own
department
DON’T work in a vacuum
DON’T attempt to process map
before you identify a beginning and
an end
DON’T get bogged down with too
much detail
DON’T struggle on your own
Do’s Don’ts

16. Results
Re-check the process by looking at the following:
• Start, end points and customers should be clear
• Inputs and outputs should be identified
• Indicate title of person / area responsible for each task
• A person not familiar with the process should be able to
easily understand the flow without any explanation
• The level of detail should be adequate to describe
inefficiencies

17. THANK YOU