Clinical Trial (CT) Process

and Brief Overview of CT

Management System
(CTMS)
Somnath Mondal
PhD Fellow
Calcutta School of Tropical Medicine
Kolkata, India
March, 14, 2017
 Content
Part-I
What is Clinical Research ?
What is Clinical Trial?
Phases of Clinical Trial.
Life Cycle of Clinical Trial
Detail discussions of Various activity i.e. clinical trial process
Rationale for effective management of Clinical Trial

Part-II
What is Project?
Basics of Project Management
Definition of Project
Stages of Project Development
 What Is Clinical Research?
A clinical study or research is a Well Planned,
Scientifically Sound and Ethically Executed
procedures (experiments) deigned to evaluate the
benefit and risk of new drugs, new medical devices
or procedures on human subjects.

Major Objectives:
To make Discovery
To Test Hypothesis
or
To Demonstrate a Known Fact
Clinical research includes:

Medical and behavioral research involving human volunteer participants

Investigations that are carefully developed and conducted with clinical

outcomes recorded

Identification of better ways to prevent, diagnose, treat, and

understand human disease

Trials that test new treatments, clinical management and clinical

outcomes, and longterm studies

Strict scientific guidelines

Ethical principles to protect participants

Research is a systematic investigation to establish fact. Treatment is the care

provided to improve a situation.
 What is Clinical Trial ?
Following testing in laboratories and animal studies, the most
promising treatments are moved into clinical trials. A clinical
trial is sometimes called a clinical study.
A clinical trial:
Effectiveness of intervention to treat a disease
Safety of a new drug
Defining dose administration
Testing drug formulation
Exploring combination therapies
Evaluating effect of therapies on quality of life
Deciphering new methods of screening, prevention diagnosis, or therapy
 Phase-2 Phase-3
1 in patient with target disease condition.
st The last phase of CT before submitting an NDA to the
Regulatory Authority
Long Term Safety
Will only be initiated when it is established in phase 2 that
Safety
To determine the safety and efficacy of IND
the drug is reasonably effective, safe and is well tolerated
target disease population..
Expanded PK/PD
i.e. Benefit Justify over Risk
bothPK/PD To evaluate the IND for longer duration on much larger
Data from endpoint objectives are collected
Confirmatory Efficacy
patient population.
Dose Finding
and analyzed
Volunteers : upto 2500 Patients worldwide ( Multicentre
Volunteers : <100 in Patients Clinically Meaningful
Global Trial)
Efficacy Double Blind compare IND with Standard Treatment
Double Blind Results
Duration: 8 months 4 years

CLINICAL TRIAL PHASES Upon completion of phase-3 trial

PHC submit NDA to RA and RA
CTs are usually categorized by Phases.
responds in three ways
Between each phase , the Pharmaceutical i)Approval for Marketing
Companies will update the Regulatory ii)Rejection
Authority on its findings, and worked with iii)Modification suggestion for re-
the Regulatory Authority to come up with conduct of Phase-3 by changing few
the best way to further test the drug safety parameters to make the phase 3
trial outcome more credible
and efficacy in the upcoming phases.

Phase-1 Phase-4
1 in human
st
Occurs after drugs approval.
To determine the toxicity level of IND in human
Safety -Pharmacovigilance PK/PD
To evaluate the ND for longer duration on much
Post Marketing Commitments
body.
Once
Safety
Toxicity level is determined

larger patient population during
Volunteers : Several Thousands.
(PMC)
real life usage

Duration: 1 - 8 years
PK
Pharmaceutical company will decide the
Effective Dosage ranges.
Health Outcome Research
Additional Trial and Information
PD
Volunteers : 15-30 in Patients
2-6 weeks Durations
Average $50-$100 a day for each participant
 Life Cycle of a Clinical Trial
CONCEPTUAL PHASE

PLANNING PHASE

IMPLEMENTATION PHASE

ANALYSIS/ PUBLICATION PHASE

Study Start up.Planning phase
1572 Form
Financial Disclosure Forms
Regulatory Documents Protocol Documentation
Medical Licenses
Drug Brochure
Delegation of Duties Log
Protocol Amendments
Study Related Correspondence
Site Selection Visits Other Forms

Investigator Meeting

Recruiting Study Participant

Source Documents
1572 Form
Financial Disclosure Forms
This form is filled out by the study coordinator and signed by
The PI and Sub-Investigators must disclose to Regulatory
.
Study PI before being submitted to the IRB, Sponsor and
Authority (RA) and IRB that there are no conflict of financial
ultimately to the regulatory Authority.
interests with the outcome of the study.

What About India?

It contains information on
This is done to add
A
layer of Transparency
Financial Disclosure andto is study process
Form 1572 to mandatory
is not ensure that
forall
The PI Name
matters
Address are being followed
Indian in the most ethical
company-sponsored way possible.
trial.
It is applicable
Curriculum Vitae to international trials conducted in India.
GenerallyY if,
Schedule any researcher
provides format forhave
the more than
Letter of $50,000 in
Undertaking
and
study sponsor companys
resemblance stock1572
this form
need for
to be disclosed.
Information of all to FDA
Sub-Investigators this purpose

This form is promise, by the clinical trial site to the Regulatory

Authority and IRB that the study will be carried out in accordance
with the GCP.
Medical Licenses
The up-to-date Medical Licenses of PIs and Sub-I,s must be
kept current by the PIs, to ensures that they are still legally
permitted to practice medicine during the study.

Drug Brochure
Also known as Investigators Brochure (IB), it can be upto 300
pages.
It contains all the information of the drug being studied in
terms of known effects in animal model, MOA and quality of
treatment, etc.
Protocol Documentation
A highly specific written document .
It is going to inform you every thing
what are you going to do?
How are you going to do?
These written document Spell out Recipe to be followed
for a particular study, as outlined by Sponsor, and
acknowledged or approved by the PI and IRB
respectively.
Delegation of Duties Log
This lists every individual who is involved in the study, from a
clerical point of view.
Every individual who are assisting the clinical trial process
from the PI to assistants and Study Coordinators, must have
their contact information listed, as well as their specific
responsibilities in the trial.

This information is important in keeping due diligence on every

aspect of the clinical trial process and making sure that each
members is accountable for following the guidelines of GCP.

It also ensures that individuals are only conducting procedures

that they are qualified and delegated to conduct.
Protocol Amendments
Any time during study the sponsor decide to re-write, change,
add to or remove any thing from the original protocol to
better suit the investigation.

The Changes must be approved by the IRB.

These approved changes are then stamped, dated and filed in
the Regulatory Folder.

Study-related Correspondence
Every item of communication between IRB, CRO and clinical
site must be documented in chronological order.
This includes final Closeout Form which is filed once the study
is concluded.
All the communications and correspondences to CRA and
Monitor must also be documented in chronological order.
Other Forms
Advertisement Approval and Letters:
Any advertisement that will be used for recruitment purpose
needs to be approved by the IRB and filed in the Regulatory
Binder.
The IRB Approval Form:
Providing that the study was in fact approved to begin by the
IRB.
Lab Certificates:
A copy of lab certificates for all Labs that will be processing
Lab samples for the clinical trial sites.
 Site Selection Visits
Before research clinic is awarded the study a monitor from
the Sponsor or the CRO will make a physical appearance at the
clinical site to make sure that the centre facility has the
resources to accommodate the study in question.
Monitor will ensures that
All PIs, S-Is and Study Coordinators have received current
GCP Training.
The Selected site facility have pool of prospective patients
The lab facility is in order
The CRF and source documentation templates are in place
for data collection.

If the Monitor will confirm that the site facility is

appropriate for the study the monitor will send a report to
the sponsors and schedule a Site Initiation Visits.
 Investigators Meeting
When the CRO or Sponsor host the large meeting for
research clinics i.e. Investigators who will be participating in
particular study.

Discussion about the study.

Training on the protocol of interest.
Information on what to look out for in terms of AE and
ADRs

This meeting is the good opportunities for sponsor to voice

their concern regarding the investigation and share data from
previous Trials.
They offer opportunities to market with fellow researchers
to meticulously learn about the Study of Interest.
 Recruiting Study Participant
Two Ways of recruit
Direct Contact
The PI of study can refer his/her
own patients from their private clinic
Colleagues or Associates of PI can
refer their patients for the study.
Prospective participant must be
prequalified by the research clinic in
order to assure that they are
appropriate trial candidates
Advertising
Flayers, Physician Letters, radio ads,
TV ads and digital adds.
Social media like Facebook, Google,
and Whats up is the promising
avenues for attracting the patients.
Digital Ads. Must be in accordance
with the GCP guidelines and must be
approved by the IRB.
Ads must ensures the safety of the public
by preventing the opportunity of
therapeutic misconception or coercion
 Source
How are SourceDocuments
documents made?
Source
What are documentation templates usually created by the
Source document?
individual clinical trial
Source document arefacility, and will vary
any written from facility
or spoken to
information
facility.
regarding the investigation which is documented and relevant
to the out come of the study.
It is highly personalized to the study itself rather than a
basic
Sourcerepeated template
information that
can take showsforms:
several no variability from
trial to trial.
Medical history, disability exam results, current medications, a
Electronic Data Capture
note that inform consent(EDC) Screen
has been shottelephone
signed, for particular
logs, the
Study
patientcould be the
history withgood
priorreference to create
clinical trials a Source
and medical visits as
documents.
documented by the PI.

Coordinators should include about their experiences with the

patients.
Running a Study.Implementation phase

Informed Consent
Study Protocol
Reporting Adverse Events
Budget and Contracts
Screening Visits
Randomization Visits
Study Visits Regular Visits

Early Termination Visits

Storing the IP
Electronic Data Capture
Subject Compensations

Study Closeout
 Informed Consent
The Informed Consent Process
The Informed Consent Form
(ICF)
The ICF is a form that informs the
patient of the purpose of the trial as
possible risks and benefit of their
participation.
The ICF must be approved, stamped
and Dated by the IRB before it is
given to prospective participants.
Only approved consent must be used
and must be documented to the
Regulatory Binders.
When the Participants are brought into
the clinical Trial Facility the PI or
Sub-Is will meet privately with
prospective participant inform the
participant of every aspect of the
study.
It is a ongoing process as new form is
generated .
When ever there is a amendment of
protocol the participant must be
reeducated about the every aspect of
the amendments or study.
There should be a regular follow ups
to make sure that the participant is
still content with the current status of
the trial.
 Study Protocol
A big and Vital part of running a clinical trial facility is
following the protocol as stringently as possible.

Any deviation from this pre-ordained protocols is carefully

examined, documented and it is required that the deviation be
reported to the IRB.

Of course a protocol Deviation (PD) form must still be filed

with the IRB, even if the protocol was broken for the safety
of the study participants.

Protocol deviation might be minor or major, they might affect

the safety of the trial participants or not.

Protocol Waiver
 Reporting Adverse Event
Any untoward medical occurrence (including a symptom /
disease or an abnormal laboratory finding) during treatment
with a pharmaceutical product in a patient or a human
volunteer that does not necessarily have a relationship with
the treatment being given.

AE document form is reported to the IRB, Study Sponsor and

contain the option to specify whether the event was directly
related to the present study, or not.

SAE are the AES that typically results into the study
participant requiring hospitalization.
 Budgets and Contracts
A good budget negotiation is essential for smooth functioning
of Trial.
Monthly payment Negotiations:
Because running clinical research is very expensive and quarterly basis payment
from sponsor may lead to the huge expenditure from PI funds.

Coverage of Screen Failure:

Screen Failures are those patients who do not pass the primary screening process
and therefore cannot be included in the study or investigation.

Prediction of Screen Failure Rate before budgeting is well known practice towards
smart Budgeting.
Negotiation for good Indemnification Clause:

This is basically a statement saying that a clinical trial facility, are not held
accountable for any harm done to study participants during the course of
study, as long as facility GCPs and study protocol.
Study Visits
 Screening Visits
PI sits down with the prospective study participant and goes
over the IC.
The PI then conducts basic medical tests to gauge
the general health of the participants including blood
draw and ECG based on protocol.

Confirmation about any exclusionary treatment that

the patient is currently taking.

Inclusion criteria compliance.

If dose not have any exclusionary criteria, then

randomization visits is established usually 1-2 weeks
from the study visits.
 Randomization Visits
The patient is randomly assigned one of three classes of drugs
via an automated system which generates random
associations:

1)The actual IND

2)A comparative, standard of treatment
3)The placebo

The patient must keep that same class during all visits and
administration of drugs.
 Regular Visits
Through out the study, the study participant may be required
to come to the clinic for regularly scheduled visits.
At this visits , adverse events are monitored along with
compliance with the IND.
Patient is usually dispensed a new supply of the study while the
previous supply is returned back.
Regular study visits are outlined in the protocol.

Early Termination Visits

Once the study participant has completed the study or if they
choose to withdraw prior to the study completion, a
termination Visit is Scheduled.
At this visits the investigational product is returned back and
any adverse events need to be recorded.
A final blood draw and ECG reading is usually obtained.
 Storing the IP
The study drug must be kept on site in a double-locked
setting.
Only PI, Pharmacists and Study Coordinator are granted
access to the drug.

IND must be preserved in temperature control device and

temperature must be recorded on daily basis.

Because the IND often have temperature restrictions and it is

important to document compliance of temperature with the
optimal temperature of the room where the study drug is
kept.
 Electronic Data Capture
Patients study notes are taken in real-time.

Periodically, the study data must be uploaded to a data bank

called CRF.

The Central CRF contain all the information from various

sources in reference to a trial, and will be reviewed by a study
Monitor when necessary.

Every piece of source documentation must be uploaded to a

CRF in a reasonable time frame usually 24 hours from the time
that information was written, so that the CRF reflects a
current overview of the study at any one time.

The CRF can be paper based but are increasingly becoming

electronic and also known as eCRF or EDC.
 Subject Compensations
In many clinical Trials, the study participant receive
compensation.
For out patient studies patient usually receive $50 for each
visit.

During in-patient studies, such as Phase-I patients gets paid

thousands of dollars as there giving more their time to the
study.
 Study Closeout
When a study is closes out the research clinic is responsible
for keeping information about the trial on file for between 5-
10 years, but some time up to 20 years.

Store all the records including the source documents and

contracts, in a separate facility indefinitely.

Each sponsor develop different protocol for how long site

store the data.
 Clinical Trial Audits
Attributes of Auditors:
The sponsor or CRO of a clinical trial is responsible for implementing quality
systems including the development of an audit plan for the trials they manage.
Auditors should be independent of the trial team / process
Purpose
andreliability and integrity of sponsors trial
Audit is designed to assess and assure the
systems against all relevant written standards.
Should be appropriately trained for their role. .
Activities and system checks which may be undertaken during
an audit include:
Staff interview: Post Audit Activity
To assess
Formal whether
Audit staff working on the trial are appropriately trained, are clear of
Report
their roleand
Findings andobservations
are workingfrom
to allany
relevant standards, should
audit conducted the protocol and standard
be documented in a
operating procedures
formal audit report. (SOPs)
Facility Tour:
Post Audit Responsibility
To assess whether there are adequate resources and that any equipment is fit for
its intended use
Any deficiencies identified during an audit should be followed up with
Document
appropriateReview:
corrective and preventative actions wherever possible.
To assess whether data reported is verifiable from source data and that written
records confirm that the trial was conducted appropriately.
 Clinical Trial Audits
IRB
CRA Audit Audit
Regulatory
Try to help the Site to Resolve AnyAuthority
Issue they find .
IRBs govern every Single clinical trial.
Audit
Why?
Must
IRB
independent Types
Regulatory authority staff members of RA
meet with Audit
Audit of drug companies or researcherCRA or Monitor Audit
involved.
the researchers and perform
They have a vested interest in Trial Facility following GCP in order to make sure
inspection of clinical trial facility (or study sites) to protect the right of the
that there trial
participant, and is
toconducted
verify the in best possible
quality way. of the data.
and integrity
A For Cause Audit:
Purpose:
This Audit also important for Sponsor orallCRO towards establishing the validity of
It
To is triggered
Regulatory
ensure authority
Safetyfor if the
can
andfuture CT
have
well being site
access raises
sourceSuspicion
documentations that the
however
of every patient/ volunteer during a trial. site
they
the
do site
not facility
have access to any the requirement.
financial data according
regarding trialto
facility.
is not conducting study
Must Approve the study before it ever begins.
the GCP or RA
Approved
For
IRBScheduling Protocol.
a Regulatory
is the sole in charge of Regulatory
Audit, Regulatory
reviewing Audit
Inspector
the study will call the site will
protocol.
Schedulean
Such Audit
a time confer
(in case of US Very Bad2Impact
FDA) within weeks . on Site facility.
Must confirm that only patients who are able to make sound judgment on their
As
ownthe auditare
health date is scheduled,
enrolled all pertinent individual involved in trial activity
in the study.
should prepare themselves and be ready with the proper documentation (Paper
A
Works
Surveillance
Ensures that
for ) as percontrol group
their assigned
Audit:
used in the studies are of the best possible
duties.
It is triggered
Regulatory authority if the treatment
approved data generated
of the countryfrom particular
of study site
when the patient
differs slightly from the data collected at every other site
may already be taking drugs for a life threatening condition
 Possible Findings and Actions
of RA Audit

No deviationNo Action

Minor deviationThese deviation must be resolved

by the Trial facility in question for future studies
.but it does not require any follow up with the FDA.

Notice of Adverse Findings

Files when serious GCP offences are found at the
trial site.
In this PI must be respond in writing.
In this the data collected from CT site in question may be disregarded
for final out come and Site may be debarred to proceed further.
Rationale for effective management of Clinical Trial
The discovery and development of New Drug is
Very Expensive both

Money . $ 800-1000 million

and
Time 10- 15 Years

Clinical development the most important step prior to a drug

entering to market takes over 5 years
Each days delay in completing the drug development and
launching the product in the market means a revenue loss of
$1.5 million
With the increasing cost and time pressure, CTs are important
area towards effective project Management.
The Pharmaceutical companies apply project management
techniques and tools to plan for timely and successful entry
of new product in the market.
 Part-II
What is Project?
Definition of Project
Stages of Project Development
 WHAT IS A PROJECT?
A project is a problem scheduled for solution.
This definition forces us to recognize that projects are aimed at
solving problems and that failure to define the problem properly is
what sometimes gets us into trouble.

What is the problem?

A desired objective is not a problem by itself.
The key to a problem is that there is an obstacle that prevents you
from closing the gap.

A problem is a gap (achieving your objective) between where you are

and where you want to be, with an obstacle that prevents easy
movement to close the gap.

Problem solving consists of finding ways of overcoming or getting

around obstacles.
 Definition of Project..
Unique process consisting of a set of coordinated
and controlled activities with start and finish dates,
undertaken to achieve an objective conforming to
specific requirements, including constraints of time,
cost, quality and resources

A Project is a planned set of activities or tasks directed

towards a major out put
or
a temporary venture undertaken to create a unique product or
service (e.g. Drug or service)

A Project has a scope

A Project has time, cost, quality and resource constraints

Examples of projects
Developing a new product or service

Effecting a change in structure, staffing, or

style of an organization

Designing a new transportation vehicle

Constructing a building or facility

Running a campaign for political office
Implementing a new business procedure or
process
 Stages of Project Development

Initiation

Plan

Deliver

Review

Close
 What do you do at each stage?
Initiate (Idea)
Development of project proposal
Define the objective of the Project
A project begins with project proposal.... includes
Written description of objective of the project
A brief statement of work to be done
Proposed Schedule specifying the start and completion steps

A project proposal.... also provides

Description of Budgets
Measure of performances
Project milestones (Specific event to be reached at point in
times)
and
Work Break Down Structure (WBS)
 Project Plan Development Approach
Step 1: Determine the project concept
Step 2: Assess the project
Step 3: Develop a strategy for the project
Step 4: Identify major milestones and initial schedule
Step 5: Define initial budget using milestones.
Step 6: Identify groups/organizations will be involved
Step 7: Determine the methods/tools to be employed in the project
Step 8: Identify the areas of risk and association them with milestones
and tasks
Step 9: Refine the schedule and budget
Step 10: Identify project manager/leader
Step 11: Identify and establish the project team
Step 12: Develop the detailed project plan
 Step 1: Determine the Project Concept
Project Concept:
Purpose of the project
Scope of the project
Benefits of the project
General roles of the project which organizations are going to
do what
Basic issues that the project may face
Evaluation of Specific Objectives & Scope
Do the objectives and scope fit with the organization?
Are the objectives too broad or too focused?
Are potential resources available?
What are the areas of risks?
Are the benefits reasonable given the purpose and scope?
 Step 2: Assess the Project

Perspectives:
Technology
Competition
Government Regulations
Politics
Cross-impacts examples
First, determine which items can be employed in the project
Second, determine where risks lie up front, before the
project is started.
Third, use the list to validate your objectives and scope.
Step 3: Develop a Strategy for the
Project
What should your strategy address?
How will you organize the project?
How will you select the project leader/team?
What will be the role of the team in project
management?
How will you manage risk and address issues?
First define your approach for each of the above
items (including alternatives)
Second refine your approach by considering
political, organizational, and technological factors
Third evaluate each alternative
 Step 4: Identify Major Milestones
and Initial Schedule

Milestones:
Draw up at least 10 to 20 milestones for each
subprojects.
Logically relate the milestones between the
subprojects in terms of dependences.
Take a piece of paper and lay it out sideways.
 Step 5: Define Initial Budget

List 4 or 5 key resources for each milestone

Next, develop an initial budget by milestones
for each subprojects (always develop your initial budget
buttom-up).
Estimate overhead and other resources as a
group (including facilities, supplies, and equipments as well as
personnel).
Step 6: Identify Groups/Organizations Will
be Involved
Organization Role Impt. of Involvement

Create an table as above.

Step 7: Determine the Methods &
Tools to be Employed in the Project

First, determine the set of methods/tools

for the actual work.
Another set of methods and tools for the
project management.
Step 8: Identify the Areas of Risk and Associate
them with Milestones & Tasks

Refine and label more detailed milestones which involve

risks (smaller milestones).
Use the list of issues that may impact the project as
defined in the project concept.
Identify any tasks (milestones) to which an issue pertains.
 Step 9: Refine the Schedule and
Budget

Refine the estimates of budgets and

schedule based upon the risks identified in
the tasks.
 Step 11: Identify and Establish the
Project Team

Identify and establish a few key people as

the core of the project team.
 Step 12: Develop Detailed Project
Plan
For each subproject enter the milestones and the
resources that you identified.
New define the tasks that lead up to each milestone
(you now have a work breakdown structure with a list
of tasks).
Establish dependencies between tasks.
Assign up 4 to 5 resources per task.
Estimate the duration of each task and set the start
date of the project.
Assign the quantity of each resource for the tasks.
Analyze the schedule and make changes by changing
duration, dependencies, resources, and starting dates.
 Setting Up Tasks

Keep the task description simple less than 30

characteristics
If the task name is compound or complex, split the task.
Start each task with an action verb.
Use a field in the project database for responsibility for
the task.
Each detailed task should be from 2 to 10 days long.
Use standard abbreviations wherever possible.
Number all tasks in an outline form.
Establish categories of resources (e.g., personnel,
equipment, facilities, etc).
 Goals and Objectives
Goals and objectives describe what we want
to achieve to solve the problem or take
advantage of the opportunity
Keep them simple
Focus on the important items
Collectively, they define the scope
They must be measurable for success
Clearly written
Goals and Objectives
- Use the SMART Test

S Specific
M Measurable
A Attainable
R Relevant
T Time-Based
 Work Breakdown Structure (WBS)
The Work Breakdown Structure is the foundation for effective project
planning, costing and management.
It is the most important aspect in setting-up a Project
and
It is the foundation on which everything else builds.

Definition:
A Work Breakdown Structure (WBS) is a hierarchical (from general to
specific) tree structure of deliverables and tasks that need to be
performed to complete a project.

WBS breaks down and organize the project into manageable pieces
like
A task is theTasks.Subtasks-----Work Packages
subdivision of the project.time duration for which no longer
than 7 months performed by one functione.g. trial supply
Pharmacy.
The work packages is a group of activities, which can be assigned to a
single functional unit in a company.
The task of regulatory approval will include the key activities such as
preparation of IND Application.
 Plan:
The purpose of project planning is to develop a project
management plan to track the progress of the tasks.

Identify milestones and outputs

Identify required funding and resources
Identify and analyse risks
Identify and analyse stakeholders
Develop project initiation document
The steps in developing project plan for
Clinical trial
1) Determine the Exact End Points:
It is important for the success of the Project....

Why?
Give the information whether to continue with the project or
to terminate at particular point of Time.
Example: In CT......Success of the Project depends on required number of Patients
Enrolment in expected time frame

Extension
Project may get extended if
enrolment of designed number of
patients are not achieved
Termination
When interim analysis indicates that
the IND is not safe , the project may
be terminated.
 ii) Describe all the key tasks to be done by each of the team
members and assess how much time it will take to complete
each activity.

Discussion with each team members is essential

Splitting of major tasks

i) Sub-Task-1

ii)Sub-Task-2

iii) Sub-Task-3

iv) Sub-Task-4
v) Sub-task-5
 Example: Obtaining Regulatory Permission
The time required (Major Task)
for each of the Sub-task can
affect the final out-come for Clinical Trial
permission

i) Preparation and
Collection of regulatory
Documents

ii) Preparation of Protocol,

CRF, ICF

e.g.
Chemistry
Manufacturing Control iii) IB
Data
Preclinical iv) Obtaining Consent
and and Undertaking from
Clinical data Investigator
v) Compilation of IND Application

vi) Submission of IND Application

iii) Describe how the tasks depends on each of other and required
sequence of activities

Identify the immediate predecessors linked to each activity

Immediate Predecessors are the activities that need to
completed immediately before another activity

IND Application Cannot be made unless all the required

documentations are available.

For This What to Do?

Dependencies Must be Identified carefully

Here the role of Project Manager is Very Very Important

Sequence the Tasks into Likely Completion Order....and Create

a Project Network
iii) Determination of the Critical Path:
It assess the minimum time the project will require.
It is the largest path through which the project network from
start to finish the complete set of planned activities.
Any delay in critical path activity will automatically delay the
over all dead line of the project assess the minimum time the
project will require.

If a Single Estimate of Time is Require to complete an activity

in not reliable.......best procedure is to use 3 times estimates.

The estimated activity time is calculated using weighted

average of a minimum , maximum and most likely time
estimates.
iii) Identify the resource requirements :
Meticulous Visualization about Money, and Materials
to complete each of the task is essential.
Cost is one of the Key Resource
Creation of Time Cost Model could be helpful in the
project management

What is Time Cost Model ?

It is the link between time to complete an activity
and the financial resources required.

The basic assumption is that there is a relationship

between activity completion time and the cost of
project.
Time Cost Model tries to develop minimum
cost schedule for an entire project & to
control expenditures during the project.
For Example:
On one hand, it cost money to expedite an activity;

on the other hand it costs money to sustain or lengthen the

project.

The cost includes the time and efforts of

manpower employed on the project and
resources related (e.g. Buying equipments,
Analyze Data, statistically prepare the
report).
These tasks again depends on subtasks e.g.
Regulatory permission depends upon
availability of regulatory documents.

Besides, some task can only be completed for

example Initiation of Clinical trial can only be
done after regulatory and Ethics approval once
available.
In contrast there are other tasks which are
important but can be completed in parallel to
above critical tasks e.g. Handling Investigator
Meetings.
 Deliver (Project Execution)
Running the project as per the plan
Reporting the Achievement of milestones
Reviewing and modifying the project plan

During this stage the project is tracked by tracking

Gannt chart. This tracking chart superimposes the
current schedule onto planned schedule to visualize
and manage the deviation.

Review (Controlling)
Measures the performance of the executing activities and
compares the results with the project plan.
 Close
Conclusion of the project
Documents the formal acceptance of the projects
product and brings all aspects of the project to a close.

The Report would capture:

Achievements Vis-a-Vis objectives

Time taken vs Schedule Time
Cost incurred Vs Budget
Problem faced and solved
Thank You