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TERMINOLOGY
TRUPTHI BV
CLINICAL TRIAL
Any investigation in human subjects intended to discover or verify the
clinical, pharmacological and/or other pharmacodynamic effects of an
investigational product(s), and/or to identify any adverse reactions to an
investigational product(s), and/or to study absorption, distribution,
metabolism, and excretion of an investigational product(s) with the object
of ascertaining its safety and/or efficacy. The terms clinical trial and clinical
study are synonymous.
CASE REPORT FORM (CRF)
A printed, optical, or electronic
document designed to record all of
the protocol required information to
be reported to the sponsor on each
trial subject.
CLINICAL STUDY/TRIAL REPORT (CSR)
A written description of a trial/study of any therapeutic, prophylactic, or
diagnostic agent conducted in human subjects, in which the clinical and
statistical description, presentations, and analyses are fully integrated
into a single report.
CONTRACT
A written, dated, and signed agreement between two or more involved
parties that sets out any arrangements on delegation and distribution of
tasks and obligations and, if appropriate, on financial matters. The
protocol may serve as the basis of a contract.
CONTRACT RESEARCH ORGANISATION
(CRO)
A person or an organization (commercial, academic, or other)
contracted by the sponsor to perform one or more of a sponsor’s trial-
related duties and functions.
INFORMED CONSENT
A process by which a subject voluntarily confirms his or her willingness
to participate in aparticular trial, after having been informed of all aspects
of the trial that are relevant to the subject’s decision to participate.
Informed consent is documented by means of a written, signed and
dated informed consent form.
LEGALLY ACCEPTABLE
REPRESENTATIVE (LAR)
An individual or juridical or other body authorized under applicable law to
consent, on behalf of a prospective subject, to the subject’s participation
in the clinical trial.
IMPARTIAL WITNESS
A person, who is independent of the trial, who cannot be unfairly
influenced by people involved with the trial, who attends the informed
consent process if the subject or the subject’s legally acceptable
representative cannot read, and who reads the informed consent form
and any other written information supplied to the subject.
INVESTIGATOR
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(PI).
PROTOCOL
A document that describes the objective(s), 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. Throughout the ICH
GCP Guideline the term protocol refers to protocol and protocol
amendments.
SPONSOR
An individual, company, institution, or organization which takes
responsibility for the initiation, management, and/or financing of a clinical
trial.
STANDARD OPERATING PROCEDURES
(SOP)
Detailed, written instructions to achieve uniformity of the performance of
a specific function.
UNEXPECTED DRUG REACTIONS
An adverse reaction, the nature or severity of which is not consistent with
the applicable product information (e.g., Investigator’s Brochure for an
unapproved investigational product or package insert/summary of
product characteristics for an approved product).
TERMINOLOGY PPT few defination of clinical research terminologys

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TERMINOLOGY PPT few defination of clinical research terminologys

  • 2. CLINICAL TRIAL Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
  • 3. CASE REPORT FORM (CRF) A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
  • 4. CLINICAL STUDY/TRIAL REPORT (CSR) A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report.
  • 5. CONTRACT A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.
  • 6. CONTRACT RESEARCH ORGANISATION (CRO) A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial- related duties and functions.
  • 7. INFORMED CONSENT A process by which a subject voluntarily confirms his or her willingness to participate in aparticular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
  • 8. LEGALLY ACCEPTABLE REPRESENTATIVE (LAR) An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial.
  • 9. IMPARTIAL WITNESS A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
  • 10. INVESTIGATOR 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(PI).
  • 11. PROTOCOL A document that describes the objective(s), 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. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.
  • 12. SPONSOR An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
  • 13. STANDARD OPERATING PROCEDURES (SOP) Detailed, written instructions to achieve uniformity of the performance of a specific function.
  • 14. UNEXPECTED DRUG REACTIONS An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product).