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.
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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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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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