The clinical trial process involves planning, implementing, and analyzing clinical studies. The planning stage includes developing the study protocol and case report forms, designing the database, selecting study sites, and obtaining regulatory approval. During implementation, sites are activated, patients are screened and enrolled, data is collected and entered, and the database is locked. In the analysis stage, statistical analysis is conducted according to the analysis plan and clinical study reports are generated for regulatory submission. The goal is to carefully plan and implement the study to generate high quality data that can be accurately analyzed to draw clear conclusions.

1. CLINICAL TRIAL PROCESS
1 Sunitha P.

2. CONTENTS
 Introduction to clinical trial process
 Study Plan
 Study Implementation
 Analysis
 Conclusion
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3. INTRODUCTION
 Clinical trial process involves
planning, implementing and analyzing clinical study
Study Plan
Implementation
Analysis
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4. STUDY PLAN
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5. PROTOCOL DEVELOPMENT
 Protocol development and finalization:
 Protocol is a document that describes the
objectives, design, methodology and statistical
considerations of a clinical trial
 An outline protocol to describe the basic details of
the trial is initially prepared
 Written according to GCP standards
 After number of discussions and meetings, the
protocol is finalized
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6. INFORMED CONSENT FORM
 Informed consent form is the learning the key facts
about a trial before deciding whether to participate.
 Research study purpose
 Risks/Benefits
 Alternative treatments
 Confidentiality of records
 Medical treatment available if injury occurs
 Whom to contact for answers to questions
 Statement that participation is voluntary
 Informed consent form is finalized before submitting
to the IRB approval
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7. CASE REPORT FORM
 Case report form is a data capture tool used in
obtaining data about the subjects
 CRF is designed and finalized according to the
protocol
 CRF can be paper based or electronic
 Data recorded on the CRFs is used to analyze the
data according to statistical plan and interpret the
results
 One study can have one or more number of case
report forms
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8. DATABASE DESIGN AND FINALIZATION
 Clinical data management encompasses the entry,
verification, validation and quality control of data
gathered during the conduct of the trial.
 The database is designed, tested and finalized
before the initiation of the trial
 CSV(Computer system validation): All computer
systems used in processing and management are
validated
 CDISC (Clinical Data Interchange Standards
Consortium) leads the development of global
system independent data standards
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9. SITE SELECTION PROCESS
 Site selection is based on
 Access to patient geographic distribution
 Past performance of site team
 Capability to recruit anticipated number of enrollment
 Availability of required equipment or specialized staff
 Confidential Disclosure Agreement (CDA) is sent to
the sites
 Site Feasibility Questionnaire (SFQ)is sent to the
site
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10. IRB/IEC APPROVAL
 IRB/IEC is an independent body constituted of
medical, scientific and nonscientific members
 This committee has been designated to
approve, monitor, and review biomedical and
behavioral research involving humans with the aim
to protect the rights and well-being of the subjects
 All clinical trials require favorable opinion from
Ethics committee before site initiation
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INITIATION

11. STUDY DRUG SUPPLY FINALIZATION
 Before the initiation drug supply plan is finalized
 Matching placebo is also ready
 Shipment of drug
 Primary, secondary packing and labeling is ready
 Blindedness testing, stability testing
 Storage requirements
 Site SOP for the inventory, usage and return/disposal is
ready
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12. STUDY IMPLEMENTATION
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13. SITE ACTIVATION
 Conduct investigator meeting
 Contract negotiations/agreements
 Prepare regulatory documents
 FDA form 1572, CVs, financial disclosure etc.
 Provide sites with clinical supplies
 Lab kits, drug supply etc.
Ready
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ACTIVATION

14. INITIAL PATIENT SCREENING
 Patients are selected on the basis of inclusion and
exclusion criteria
 I/E criteria is a screening questionnaire that
evaluates the subject’s eligibility to participate in the
study
 Informed consent form is signed by the subject after
the screening questionnaire
Meets
Criteria
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15. INFORMED CONSENT
 Eligible subjects are informed about the required
information about the study
 Informed consent is signed by the subjects after
decision
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16. BASELINE EXAM AND ENROLLMENT
 Baseline examination is the assessment taken
before the subject is given any treatment
 Demographic data
 Physical examination data
 Clinical data
 Lab data etc.
 The subject is enrolled and randomized into the
study after the baseline parameters are taken
 The enrolled subject is given the treatment
assigned to the study group.
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17. DATA ACQUISION AND DATA ENTRY
 Data comes from various source documents
 From Subject - Diaries, self report, questionnaire
 Investigators - clinical findings
 Lab test reports – Urine, blood test, ECG etc.
 Other sources – previous medical records etc.
 Data from the source document is entered into the
case report forms
 Events are coded using standard medical
dictionaries
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18. DATA VALIDATION
 Data validation plays key role in discrepancy
management
 Validation is checking the data for discrepancies
and outlier values
 Objective for data validation is to assure the validity
and accuracy of the data
 In case of discrepancy, a DCF (Data Clarification
Form) is raised and sent to the investigator
DCF
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19. DATA CLEANING AND QUALITY CONTROL
 After the queries are resolved, the database is
updated
 The updated database is now ready for the quality
check
 Quality control procedure is run to assure that the
database is clean with no discrepancies
 Data listings are reconciled with DCF and CRF
 Safety data is reconciled with pharmacovigilance
SAE data
Quality
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20. DATABASE LOCK
 The database is locked after all corrections are
done
 A locked database means
 All discrepancies closed
 DCFs received and updated
 coding complete
 SAE Reconciliation complete
 The data is ready to be submitted for analysis
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21. STATISTICAL ANALYSIS
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22. STATISTICAL ANALYSIS AND REGULATORY
SUBMISSION
 Import study data for analysis
 Statistical analysis is done by SAP (Statistical
Analysis Plan)
 Primary and secondary outcome measures are
calculated using statistical analysis methods
 Eg: Mean, t-test and chi-square test etc.
 After the statistical analysis, the tables, listings and
figures are published
 Clinical Study reports are generated for the
regulatory submission
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23. CONCLUSION
 Clinical trial process involves careful planning,
implementing and analyzing a clinical trial with good
practices
 A clinical trial must be planned in such a way that
the prerequisites are ready in time
 After careful planning, the study must be
implemented and data must be maintained with
high accuracy for the subsequent analysis
 Unambiguous conclusion regarding the clinical
outcome of the test treatment/device is ideal
 One must always strive for the ideal, but in most
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cases have to settle for the best comprise

24. QUESTIONS ?
24 Thank You