site selection role and responsibility- PI, CRC, SMO

1. CT-Planning
13-April- 2021 SHEETU 1
Made by:
Sheetu

2. Protocol
CRF Design
Database
Design
Validation/
Derivation
Procedures
Activated
database ready
toaccept
production data
Study Start-up Process
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3. Activated DB
Data Entry /
Loading (CRF
& external
data)
Discrepancy
Management
Safety Data
Recon.
Coding terms
Query
Generation
Resolution &
update of DB
Manual
Check/ QC
Study Conduct Process
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4. Discrepancy
Management
Query
generation
Resolution
and/or update
of DB
Manual
check/QC/CR
F tracking
DB lock and
freeze
Safety Data
Recon.
Coding terms
Study Closeout Process
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5. Site Selection
• Experience and qualification of the investigator along with monitor
• Experience and qualification of the study coordinator and other staff
• Availability of suitable patient population
• Availability of equipment’s
• Availability of track records with previous similar trials
• Availability of geographical location
• Availability of rare patient recruitment
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6. • The investigator should provide copy of CV or other relevant document requested by
sponsor, the ethics committee, the CRO. Or the regulatory authority.
• The investigator selection is based on education, experience and training provided.
• The investigator should be able to demonstrate potential for recruiting the required
number of subjects.
• The investigator should have sufficient time to properly conduct and complete trial.
• The investigator should be thoroughly familiar with Safety, Efficacy, Appropriate use
of investigational product described in protocol, investigational brochure, other
information source by sponsor
• The investigator should be aware of and comply with: GCP’s, SOP’s, Applicable
regulatory requirement
Responsibility of The Investigator
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7. Sponsor ask CRO to conduct a
feasible trial and sponsor
suggests PI
CRO appoints monitors to collect
information about potential site and
investigation
Monitor uses sponsor list of suggested
sites and investigator along with other
resources and conduct feasibility interview.
CRO project manager fine-tunes the list &
decides which centre to suggest to the
sponsor.
Sponsor accepts the pro and Proceed with
selection process.
Process of Site and Investigator Selection
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8. • SPONSORS
• Contract Research Organization ( CRO )
• INVESTIGATORS
• ETHICS COMMITTEE
• REGULATORY AUTHORITY
• STUDY SUBJECT ( PATIENTS )
• Sponsor takes the responsibility for the Initiation, Management, and/or financing the Clinical Trial
• CRO is the Organization Contracted by the Sponsor to Perform One or More of Sponsor’s Trial related Duties and Functions.
• Investigator is responsible for the Conduct of a Clinical Trial at a Site.
• Ethics Committee ensures prtection of Rights, Safety, and Wellbeing of the Subjects involved and to provide Public Assurance of the
Protection
• Study Subjects ( Patients ) are Individual who Participate in the Study ( CT ) Voluntarily.
Stakeholders of the Clinical Trials are:
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9. 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
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10. Major players in Research team
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• Investigator
• Clinical Research Associate
• Clinical Research Coordinator
• Data Manager
• Statistician
• Patients
• IRB
• Regulatory Body

11. Principal Investigator
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• A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of
individuals at a trial site, the investigator is the responsible leader of the team and may be called the
principal investigator.
Responsibilities : Investigator
 Investigators Qualifications
 Adequacy of Resources
 Medical Care of Study Participants
 Communication with the IRB / IEC
 Compliance with the Protocol
 Investigational Product care
 Randomization & unbinding
 The Informed Consent
 Records and Reports
 Progress Reports
 Safety Reporting
 Stopping or suspending a study
 Final report by investigator

12. CRC
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• Person who handles most of the administrative responsibilities of a clinical trial, acts
as liaison between investigative site and sponsor, and reviews all data and records
before a monitor’s visit.
• Functions as extension of Investigator.
• Involved in operational duties – recruiting, scheduling, completing CRF’s, administering
tests.
• A person appointed by the Sponsor or Contract Research Organisation (CRO) for
monitoring and reporting the progress of the trial and for verification of data.
• The monitor ensures that the trial is conducted, recorded and reported in accordance
with the Protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)
and the applicable regulatory requirements.

13. • Main line of communication between sponsor and site
• Site feasibility Training and support
• to site staff & selection
• Protocol & GCP Compliance
• Document completeness & maintenance
• Source Data Verification
• Trial material accounting
• Ensure timely AE & SAE reporting
• Monitoring reports & other office documentations
• Prepare and assist in IRB, Regulatory and internal audit or
inspection
• Assist in IRB and Regulatory Submission
• Assist in IRB and Regulatory Submission
Responsibilities: Monitor
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14. Site Selection
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• It can be defined as a systematic planned process to evaluate
and select an investigator and site for conduct of clinical trial
• Factors involved in selection
– Reputation in field
– Facilities desirable for trial conduct
– Access to patient population
– Accessible geographic location
– Anticipated time for initiation and completion of trial
– Relationship with sponsor
– Budgetary factors
– Past experience
– Experienced staff
– EC–ability to process protocols fairly and expeditiously

15. Study Close Out
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• After ensuring the study is complete
• All CRF received
• All study material is accounted for
• All investigational product is accounted for and
balance returned to sponsor
• Ensure payment completion

16. • Develops and implements a plan for recruiting subjects into each study.
• Identifies media to be used for patient recruitment (e.g., newspapers, radio, telemarketing, etc.).
• Implements selected communications strategies (e.g., generating mailing lists, writing advertising copy, etc.).
• Regulatory Review and Management: Manages the preparation and submission of regulatory materials to
sponsors and oversight organizations.
• Coordinates approval of materials developed or modified at site by sponsoring or managing organization, as
required.
• Coordinates approval of materials developed by site or sponsoring or managing organization by Institutional
Review Boards (IRBs) and other outside regulatory organizations, as required.
• Ensures that studies are implemented in compliance with Good Clinical Practice (GCP) guidelines as
promulgated by the Food and Drug Administration (FDA) and the International Conference on Harmonization
(ICH).
• Study Operations: Manages all aspects of clinical research studies and related office operations. • Hires, trains,
and manages Clinical Research Coordinators, Assistant Clinical Research Coordinators, Patient Recruitment
Coordinators, and the Laboratory personnel.
• Indirectly manages other clinical and administrative staff and contractors (e.g., investigators, clinicians, etc.).
Manages the processes of subject recruitment, appointment scheduling, informed consent, subject visits,
source document preparation, Case Report Form and other document preparation and disposition, and
regulatory documentation and reporting.
SMO roles
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17. 13-April- 2021 SHEETU 17
SAMPLE SIZE
• This is the sub-population to be studied in order to make an inference to a reference
population (A broader population to which the findings from a study are to be generalized)
In census, the sample size is equal to the population size. However, in research, because of
time constraint and budget, a representative sample are normally used.
• The larger the sample size the more accurate the findings from a study.
• Availability of resources sets the upper limit of the sample size.
• While the required accuracy sets the lower limit of sample size
• Therefore, an optimum sample size is an essential component of any research.

18. • Sample size determination is the mathematical estimation of the number of
subjects/units to be included in a study.
• When a representative sample is taken from a population, the finding are
generalized to the population.
• Optimum sample size determination is required for the following reason
• To allow for appropriate analysis ,To provide the desired level of accuracy ,To
allow validity of significance test.
SAMPLE SIZE DETERMINATION
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19. To calculate the minimum sample size
• To calculate the minimum sample size required for accuracy, in estimating proportions, the
following decisions must be taken:
• Decide on a reasonable estimate of key proportions (p) to be measured in the study 3. Decide on
the degree of accuracy (d) that is desired in the study. ~1%-5% or 0.01 and 0.05 4. Decide on the
confidence level(Z) you want to use. Usually 95%≡1.96. 5. Determine the size (N) of the population
that the sample is supposed to represent. 6. Decide on the minimum differences you expect to
find statistical significance.
• For population >10,000.
n=Z2pq/d2
n= desired sample size(when the population>10,000)
• Z=standard normal deviate; usually set at 1.96(or a~2), which correspond to 95% confidence level.
• p=proportion in the target population estimated to have a particular characteristics. If there is no
reasonable estimate, use 50%(i.e 0.5) q=1-p(proportion in the target population not having the
particular characteristics)
• d= degree of accuracy required, usually set at 0.05 level( occasionally at 2.0)
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