Clinical trial Documentation

1. GUIDELINES FOR THE
PREPARATION OF CLINICAL TRIAL
DOCUMENTATION
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CLINICAL RESEARCH AND PHARMACOVIGILANCE

2. CONTENT
 INTRODUCTION
 CLINICAL TRIALS
 CLINICAL TRIAL DOCUMENTATION
 ESSENTIAL DOCUMETS FOR CLINICAL TRIALS
 INVESTIGATOR’S BROCHURE
 CASE REPORT FORM
 CLINICAL STUDY REPORTS
 DECLARATION OF HELSINKI
 PARTS OF PROTOCOL
 MONITORING IN CLINICAL TRIAL
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3. INTRODUCTION
Proper documentation is critical to the success of a
clinical study. Every aspect of the study must be
documented in order to obtain useful data and
demonstrate compliance with Good Clinical
Practice(GCP) guidelines and with all applicable
regulations.
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4. CLINICAL TRIALS
The International Conference of Harmonization defines a clinical trial as,
“Any investigation in humans subjects intended to discover or
verify the clinical, pharmacological or other pharmacodynamic
effects of an investigational product, or to identify any ADR to an
investigational drugs, or to study ADME of drug with the
objective of ascertaining the safety and efficacy”.
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5. CLINICAL TRIAL DOCUMENTATION
 All records, in any form (including, but not limited to, written, electronic, magnetic and optical records and
scans, x-rays and electrocardiograms) that describes or record the methods, conduct or results of a trial, the
factors affecting a trial and the actions taken.
 Such a record is known as,” Document” and process is “ Documentation”
 The trial documents are both a resource and an outcome; they are the outcome of the study and a resource
for the regulators.
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6. ESSENTIAL DOCUMENTS FOR CLINICAL
TRIALS
The Essential Documents for Clinical Trials are as follows:-
INVESTIGATOR’S
BROCHURE
CASE REPORT
FORM
CLINICAL STUDY
REPORTS
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7. INVESTIGATOR’S BROCHURE (IB)
List of Abbreviations
Contents and summary
Introduction provides the chemical name (and generic and trade names, id approved) of
the investigational product.
Physical, chemical and pharmaceutical properties and formulation of the medicinal
product.
Non-clinical studies and clinical studies and their results.
Conclusion and guidance for the investigators
References (at the end of section)
NOTE :- The Investigator’s Brochure should be reviewed at least annually and revised as
necessary in compliance with a standard procedures established by drug development
company.
Read the details through following link:-
investigator brochure.docx 7

8. CASE REPORT FORM (CRF)
o CRF is a paper or electronic document designed to record all the information for an
individual study subject required by the study protocol.
o All CRF’s should include the following data:
 Study title and number
 Investigator’s name
 Study subjects/ patient ID (number and initials)
 Inclusion / exclusion criteria
 Demographic data
 Detailed description of dosage regimens of investigational drug
 Concomitant treatment
 Adverse events (side effects and intercurrent diseases)
 Conclusion on subject’s health
 Investigator’s signature and date
Read the details through following link :-Case report form.docx
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9. CLINICAL STUDY REPORTS
 The guidelines ICH E6 defines the protocol/report as ,“ A
document that describes the objectives, design,
methodology, statistical considerations and organization of
a trial.”
 The protocol usually also gives the background and
rationale for the trial but these could be provided in other
protocol referenced documents also.
 Appendix II (6) of schedule Y to Drugs and Cosmetic rules
(2005) implies that all clinical trials to be carried out as per
the conditions laid down in the “ Declaration of Helsinki”
(DOH)
Read the details through following links :-
CLINICAL STUDY REPORT.docx
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10. DECLARATION OF HELSINKI
The protocol should be submitted for
consideration, comment, guidance
and where appropriate, approval to a
specially appointed ethical review
committee which must be
independent of the investigator, the
sponsor, or any other kind of undue
influence. This independent
committee should be in conformity
with the laws and regulations of the
country in which the research
experiments is performed.
The subject must
be volunteers and
informed
participants in the
research project
Both author and publisher
have ethical obligations. In
publication of the results of
research, the investigators
are obliged to preserve the
accuracy of the results.
Negative as well as positive
results should be published
or otherwise publicly
available.
It is the duty of the
physician in medical
research to protect
the life, health,
privacy, and dignity of
the human subjects.
In medical research on
human subjects,
considerations related
to the well-being of the
human subject should
take precedence over
the interests of science
and society
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11. PARTS OF PROTOCOL
INTRODUCTION BACKGROUND
ELIGIBILITY
CRITERIA
STUDY
DESIGNS/METHODS
SAFETY
EVENTS
REGULATORY
GUIDANCE
STATISTICAL
SECTION
HUMAN SUBJECTS
PROTECTION
(INFORMED CONSENT
FORM)
OBJECTIVES
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12. MONITORING IN CLINICAL
TRIALS
PURPOSES
 The rights and well-being of human
subjects are protected.
 The reported trial data are accurate,
complete and verifiable from source
documents.
 The conduct of the trial is in
compliance with the currently
approved protocol/ amendments
with GCP and with the applicable
regulatory requirements.
SELECTION AND QUALIFICATIONS
 Monitors should be appointed by the
sponsor.
 Monitors should be appropriately trained
and should have the scientific and clinical
knowledge needed to monitor the trial
adequately.
 Monitors should be thoroughly familiar
with the investigational products, the
protocol, written informed consent form
and any other written information to be
provided to subjects the sponsor’s SOPs,
GCP and the applicable regulatory
requirements.
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13. THANKYOU
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