Clinical trials are research studies performed in humans to test new drugs or treatments. They follow a multi-phase process to test safety and efficacy. The document defines clinical trials and describes their purpose to discover or verify clinical and pharmacological effects of investigational products. It also outlines the different types of clinical trials including treatment, prevention, and screening trials. The phases of clinical trials are explained including phases I-III. Key documents for clinical trials are also listed such as the investigator's brochure, clinical study protocol, case report forms, informed consent forms, and clinical study reports.
This document provides definitions for key terms related to clinical trials and good clinical practice. It defines 58 terms, including adverse event, protocol, investigator, informed consent, monitoring, quality assurance and quality control. The definitions aim to clarify the proper conduct of clinical research and protection of trial subjects, according to international ethical and regulatory standards.
The document defines and explains 45 key terms related to clinical trials and research. It provides concise definitions for terms like adverse event, audit, blinding, clinical trial, compliance, documentation, good clinical practice, informed consent, investigator, monitoring, protocol, quality assurance, randomization, regulatory authority, serious adverse event, sponsor, subject, and trial site. Each term is defined in 1-2 sentences and examples are sometimes provided to further explain the term.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
This document defines key terms related to clinical research and drug development:
- It describes terms such as investigational product, protocol, informed consent, inclusion/exclusion criteria, adverse events, randomization, blinding, case report forms, data monitoring committees, good clinical practice guidelines, investigators, monitors, and institutional review boards.
- It provides concise definitions of these important concepts to clarify roles and procedures in clinical trials and medical research involving human subjects.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
The document outlines the roles and responsibilities of sponsors according to ICH-GCP guidelines. It discusses that sponsors are responsible for initiating, managing, financing, and monitoring clinical trials. They must ensure trials are conducted according to GCP standards, applicable regulations, and the approved protocol. Sponsors are also responsible for safety monitoring, reporting adverse events, quality assurance, selecting and compensating investigators, and maintaining required trial documentation.
Clinical trials are research studies performed in humans to test new drugs or treatments. They follow a multi-phase process to test safety and efficacy. The document defines clinical trials and describes their purpose to discover or verify clinical and pharmacological effects of investigational products. It also outlines the different types of clinical trials including treatment, prevention, and screening trials. The phases of clinical trials are explained including phases I-III. Key documents for clinical trials are also listed such as the investigator's brochure, clinical study protocol, case report forms, informed consent forms, and clinical study reports.
This document provides definitions for key terms related to clinical trials and good clinical practice. It defines 58 terms, including adverse event, protocol, investigator, informed consent, monitoring, quality assurance and quality control. The definitions aim to clarify the proper conduct of clinical research and protection of trial subjects, according to international ethical and regulatory standards.
The document defines and explains 45 key terms related to clinical trials and research. It provides concise definitions for terms like adverse event, audit, blinding, clinical trial, compliance, documentation, good clinical practice, informed consent, investigator, monitoring, protocol, quality assurance, randomization, regulatory authority, serious adverse event, sponsor, subject, and trial site. Each term is defined in 1-2 sentences and examples are sometimes provided to further explain the term.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
This document defines key terms related to clinical research and drug development:
- It describes terms such as investigational product, protocol, informed consent, inclusion/exclusion criteria, adverse events, randomization, blinding, case report forms, data monitoring committees, good clinical practice guidelines, investigators, monitors, and institutional review boards.
- It provides concise definitions of these important concepts to clarify roles and procedures in clinical trials and medical research involving human subjects.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
The document outlines the roles and responsibilities of sponsors according to ICH-GCP guidelines. It discusses that sponsors are responsible for initiating, managing, financing, and monitoring clinical trials. They must ensure trials are conducted according to GCP standards, applicable regulations, and the approved protocol. Sponsors are also responsible for safety monitoring, reporting adverse events, quality assurance, selecting and compensating investigators, and maintaining required trial documentation.
institutional review board and independent ethics committeeMOHAMMAD ASIM
The document discusses the role and responsibilities of institutional review boards (IRBs) in protecting human subjects in clinical research. It provides details on:
- The composition and quorum requirements of IRBs, including the need for diverse expertise and community representation.
- The functions of IRBs, which include reviewing research protocols, approving studies, overseeing informed consent processes, and ensuring ongoing ethical review of approved studies.
- The responsibilities of IRBs in evaluating risks and benefits to research participants, assessing payment amounts and methods, and requiring modifications or halting studies when necessary.
- The necessary components of informed consent forms used in clinical studies, including study details, risks/benefits, confidentiality
The document outlines the qualifications, roles, and responsibilities of investigators conducting clinical trials. It discusses that investigators should be qualified by training and experience to properly conduct trials. They must ensure adequate resources and facilities, obtain informed consent, maintain product accountability, and protect subject safety by reporting adverse events. Investigators are responsible for adhering to the approved protocol, maintaining communication with oversight bodies, and providing a comprehensive final report at the end of the trial.
Designing of clinical study protocol rumana hameedRumana Hameed
This document provides guidance on designing clinical study documents, including protocols and case report forms (CRFs). It discusses key components of trial master files, protocols, and their amendments. Protocols should include background information, objectives, design, endpoints, inclusion/exclusion criteria, and plans for statistical analysis and publication. CRFs are important trial documents used to collect patient data uniformly. Their design should follow guidelines, with clear instructions and formatting. Errors in CRFs should be addressed through queries. Overall, the document outlines best practices for developing the main documents used to conduct clinical trials and collect trial data.
This document provides guidelines for clinical trial documentation. Proper documentation is critical for clinical study success and demonstrates compliance with regulations. Essential documents include the investigator's brochure, case report form, and clinical study reports. The investigator's brochure provides drug details while the case report form records individual subject data. Clinical study reports define the protocol and objectives. Monitoring ensures accurate reporting and ethical conduct in compliance with Good Clinical Practice standards and regulatory requirements.
Designing of clinical study documentation -protocol and crfRumana Hameed
The document discusses guidelines for designing clinical study documentation, including protocols and case report forms (CRFs). It provides details on establishing master files, protocol contents such as objectives, design, endpoints, and statistical analysis plans. It also covers CRF design, including formatting, instructions, question types, and procedures for corrections. The goal is to create documentation that clearly conveys all study details and collects comprehensive and accurate patient data to allow for analysis and regulatory review.
This document outlines the requirements and guidelines for conducting clinical trials and obtaining permission to import or manufacture new drugs in India. It discusses the need to frame guidelines for clinical research and regulation of new drugs. Key points include that clinical trials require permission from the licensing authority and approval from ethics committees. Sponsors must submit various data on the drug and trials must be conducted according to Good Clinical Practice guidelines. Informed consent is required from all subjects and safety of subjects must be protected at all stages of the drug development and approval process. Trials generally proceed through Phases I-III to evaluate safety, efficacy, and optimal dosing.
ROLES AND RESPONSIBILITIES OF sponsor and CRO.pptxPraveen kumar S
The document discusses the roles and responsibilities of clinical trial sponsors and contract research organizations (CROs). It outlines that sponsors are responsible for initiating, managing, and financing clinical trials in accordance with good clinical practice guidelines. They must select investigators, monitor trials, ensure regulatory approval is obtained, and address safety issues. CROs assist sponsors by providing outsourced clinical research services like monitoring, data management, and regulatory support. Sponsors and CROs have legal contracts defining their responsibilities for conducting research properly and protecting participant safety.
GCP Guideline published by Turkish Medicine and Medical Device AgencySerkan Kaçar
The document provides guidelines for Good Clinical Practices (GCP) in conducting clinical studies and trials involving human subjects. It outlines key definitions related to clinical research and trials, such as adverse events, informed consent, investigators, and ethics committees. It emphasizes that the rights, safety and well-being of clinical trial subjects are most important and should prevail over other interests. Clinical trials must be designed and conducted according to scientific and ethical standards to ensure quality and protection of subjects.
This document defines important terminology used in clinical research. It includes definitions for terms like adverse reaction, arm, blinded study, investigator, monitor, protocol, randomization, sponsor, among others. The definitions provide brief explanations of the key concepts and roles involved in planning and conducting clinical trials.
Worldwide comprehensive study of guideline on clinical trialRGPV BHOPAL
The document provides information on various aspects of clinical trials including:
- The different phases of clinical trials from Phase 0 to Phase V
- Key elements of a clinical trial protocol such as objectives, design, and methodology
- Regulatory requirements for conducting clinical trials including compliance with ICH GCP guidelines
- Common recruitment strategies and important documents required for clinical trial authorization applications such as the clinical trial protocol, investigator brochure, and informed consent forms.
Clinical trials are research studies that test new medical treatments and drugs on human volunteers. They are important for discovering new treatments and determining what is safe and effective for human use. There are different types of clinical trials including observational studies that monitor participants' health over time without interventions, and interventional studies that test new drugs, therapies or treatments. Clinical trials go through several phases and are tightly regulated to protect participants and ensure scientific validity.
The document discusses important clauses that should be included in a clinical trial agreement (CTA). It outlines key provisions such as describing the clinical trial, the parties involved including sponsors, institutions, and principal investigators, governance and regulatory compliance, the obligations of each party, study conduct, monitoring, insurance, indemnification, terms and termination, governing law, and dispute resolution. The CTA is an essential legally binding document that regulates the relationship between the parties and addresses their rights and responsibilities regarding the clinical trial.
This document provides an overview of clinical trial teams and their responsibilities. It defines a clinical trial and outlines the approval process. The main stakeholders in a clinical trial are identified as the sponsor, investigators, ethics committee, regulatory authorities, and study subjects. Key responsibilities are described for each stakeholder. The clinical trial process is outlined as initiating a trial, conducting it, closing it, and registering/publishing results. Specific responsibilities are defined for investigators, study coordinators, sponsors, and contract research organizations.
Role and Responsiblities of Sponsor as per ICH GCP.pptxsreesujithra
The sponsor is responsible for the overall conduct of the clinical trial according to GCP guidelines. This includes proper trial design, monitoring, data handling, record keeping, reporting safety issues and audit. The sponsor designates appropriate medical and scientific experts to oversee the trial. It also selects and monitors investigators and ensures ethics committee approval and participant consent are obtained. The sponsor manufactures, supplies and handles the investigational product and maintains its quality. It is responsible for reporting adverse events and trial results to regulatory authorities.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
This educational module describes Good Clinical Practice (GCP) standards developed by ICH for conducting clinical trials involving human subjects ethically and scientifically. It provides guidance to investigators on their roles and responsibilities, including obtaining informed consent, complying with protocols, safety reporting, and maintaining accurate records. Adherence to GCP assures trial credibility and subjects' well-being consistent with the Declaration of Helsinki.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
This document provides guidance on developing clinical trial protocols. It explains that every clinical trial begins with developing a protocol, which is a document that describes how the trial will be conducted. The protocol ensures safety and integrity. Key topics that should be included in a protocol according to guidelines are: background, objectives, study design, selection and treatment of subjects, assessment of efficacy and safety, statistics, ethics, and data handling. The protocol language should be understandable to physicians, nurses, reviewers, and ethics boards. Regulations provide requirements for protocols regarding application processes and responsibilities of sponsors, investigators, and ethics committees.
This presentation focuses on Institutional Review Board/ Institutional Ethics Committee, Informed Consent Form and Protocol for a Research. The responsibilities of various personals have also been covered.
This document provides definitions for common terms and acronyms used in clinical research and the FDA regulatory review process. It includes over 50 terms related to clinical trials, drug development, FDA centers and programs, study design, data collection and analysis. The glossary is intended to define commonly used and emerging terms to facilitate understanding in this area.
institutional review board and independent ethics committeeMOHAMMAD ASIM
The document discusses the role and responsibilities of institutional review boards (IRBs) in protecting human subjects in clinical research. It provides details on:
- The composition and quorum requirements of IRBs, including the need for diverse expertise and community representation.
- The functions of IRBs, which include reviewing research protocols, approving studies, overseeing informed consent processes, and ensuring ongoing ethical review of approved studies.
- The responsibilities of IRBs in evaluating risks and benefits to research participants, assessing payment amounts and methods, and requiring modifications or halting studies when necessary.
- The necessary components of informed consent forms used in clinical studies, including study details, risks/benefits, confidentiality
The document outlines the qualifications, roles, and responsibilities of investigators conducting clinical trials. It discusses that investigators should be qualified by training and experience to properly conduct trials. They must ensure adequate resources and facilities, obtain informed consent, maintain product accountability, and protect subject safety by reporting adverse events. Investigators are responsible for adhering to the approved protocol, maintaining communication with oversight bodies, and providing a comprehensive final report at the end of the trial.
Designing of clinical study protocol rumana hameedRumana Hameed
This document provides guidance on designing clinical study documents, including protocols and case report forms (CRFs). It discusses key components of trial master files, protocols, and their amendments. Protocols should include background information, objectives, design, endpoints, inclusion/exclusion criteria, and plans for statistical analysis and publication. CRFs are important trial documents used to collect patient data uniformly. Their design should follow guidelines, with clear instructions and formatting. Errors in CRFs should be addressed through queries. Overall, the document outlines best practices for developing the main documents used to conduct clinical trials and collect trial data.
This document provides guidelines for clinical trial documentation. Proper documentation is critical for clinical study success and demonstrates compliance with regulations. Essential documents include the investigator's brochure, case report form, and clinical study reports. The investigator's brochure provides drug details while the case report form records individual subject data. Clinical study reports define the protocol and objectives. Monitoring ensures accurate reporting and ethical conduct in compliance with Good Clinical Practice standards and regulatory requirements.
Designing of clinical study documentation -protocol and crfRumana Hameed
The document discusses guidelines for designing clinical study documentation, including protocols and case report forms (CRFs). It provides details on establishing master files, protocol contents such as objectives, design, endpoints, and statistical analysis plans. It also covers CRF design, including formatting, instructions, question types, and procedures for corrections. The goal is to create documentation that clearly conveys all study details and collects comprehensive and accurate patient data to allow for analysis and regulatory review.
This document outlines the requirements and guidelines for conducting clinical trials and obtaining permission to import or manufacture new drugs in India. It discusses the need to frame guidelines for clinical research and regulation of new drugs. Key points include that clinical trials require permission from the licensing authority and approval from ethics committees. Sponsors must submit various data on the drug and trials must be conducted according to Good Clinical Practice guidelines. Informed consent is required from all subjects and safety of subjects must be protected at all stages of the drug development and approval process. Trials generally proceed through Phases I-III to evaluate safety, efficacy, and optimal dosing.
ROLES AND RESPONSIBILITIES OF sponsor and CRO.pptxPraveen kumar S
The document discusses the roles and responsibilities of clinical trial sponsors and contract research organizations (CROs). It outlines that sponsors are responsible for initiating, managing, and financing clinical trials in accordance with good clinical practice guidelines. They must select investigators, monitor trials, ensure regulatory approval is obtained, and address safety issues. CROs assist sponsors by providing outsourced clinical research services like monitoring, data management, and regulatory support. Sponsors and CROs have legal contracts defining their responsibilities for conducting research properly and protecting participant safety.
GCP Guideline published by Turkish Medicine and Medical Device AgencySerkan Kaçar
The document provides guidelines for Good Clinical Practices (GCP) in conducting clinical studies and trials involving human subjects. It outlines key definitions related to clinical research and trials, such as adverse events, informed consent, investigators, and ethics committees. It emphasizes that the rights, safety and well-being of clinical trial subjects are most important and should prevail over other interests. Clinical trials must be designed and conducted according to scientific and ethical standards to ensure quality and protection of subjects.
This document defines important terminology used in clinical research. It includes definitions for terms like adverse reaction, arm, blinded study, investigator, monitor, protocol, randomization, sponsor, among others. The definitions provide brief explanations of the key concepts and roles involved in planning and conducting clinical trials.
Worldwide comprehensive study of guideline on clinical trialRGPV BHOPAL
The document provides information on various aspects of clinical trials including:
- The different phases of clinical trials from Phase 0 to Phase V
- Key elements of a clinical trial protocol such as objectives, design, and methodology
- Regulatory requirements for conducting clinical trials including compliance with ICH GCP guidelines
- Common recruitment strategies and important documents required for clinical trial authorization applications such as the clinical trial protocol, investigator brochure, and informed consent forms.
Clinical trials are research studies that test new medical treatments and drugs on human volunteers. They are important for discovering new treatments and determining what is safe and effective for human use. There are different types of clinical trials including observational studies that monitor participants' health over time without interventions, and interventional studies that test new drugs, therapies or treatments. Clinical trials go through several phases and are tightly regulated to protect participants and ensure scientific validity.
The document discusses important clauses that should be included in a clinical trial agreement (CTA). It outlines key provisions such as describing the clinical trial, the parties involved including sponsors, institutions, and principal investigators, governance and regulatory compliance, the obligations of each party, study conduct, monitoring, insurance, indemnification, terms and termination, governing law, and dispute resolution. The CTA is an essential legally binding document that regulates the relationship between the parties and addresses their rights and responsibilities regarding the clinical trial.
This document provides an overview of clinical trial teams and their responsibilities. It defines a clinical trial and outlines the approval process. The main stakeholders in a clinical trial are identified as the sponsor, investigators, ethics committee, regulatory authorities, and study subjects. Key responsibilities are described for each stakeholder. The clinical trial process is outlined as initiating a trial, conducting it, closing it, and registering/publishing results. Specific responsibilities are defined for investigators, study coordinators, sponsors, and contract research organizations.
Role and Responsiblities of Sponsor as per ICH GCP.pptxsreesujithra
The sponsor is responsible for the overall conduct of the clinical trial according to GCP guidelines. This includes proper trial design, monitoring, data handling, record keeping, reporting safety issues and audit. The sponsor designates appropriate medical and scientific experts to oversee the trial. It also selects and monitors investigators and ensures ethics committee approval and participant consent are obtained. The sponsor manufactures, supplies and handles the investigational product and maintains its quality. It is responsible for reporting adverse events and trial results to regulatory authorities.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
This educational module describes Good Clinical Practice (GCP) standards developed by ICH for conducting clinical trials involving human subjects ethically and scientifically. It provides guidance to investigators on their roles and responsibilities, including obtaining informed consent, complying with protocols, safety reporting, and maintaining accurate records. Adherence to GCP assures trial credibility and subjects' well-being consistent with the Declaration of Helsinki.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
This document provides guidance on developing clinical trial protocols. It explains that every clinical trial begins with developing a protocol, which is a document that describes how the trial will be conducted. The protocol ensures safety and integrity. Key topics that should be included in a protocol according to guidelines are: background, objectives, study design, selection and treatment of subjects, assessment of efficacy and safety, statistics, ethics, and data handling. The protocol language should be understandable to physicians, nurses, reviewers, and ethics boards. Regulations provide requirements for protocols regarding application processes and responsibilities of sponsors, investigators, and ethics committees.
This presentation focuses on Institutional Review Board/ Institutional Ethics Committee, Informed Consent Form and Protocol for a Research. The responsibilities of various personals have also been covered.
This document provides definitions for common terms and acronyms used in clinical research and the FDA regulatory review process. It includes over 50 terms related to clinical trials, drug development, FDA centers and programs, study design, data collection and analysis. The glossary is intended to define commonly used and emerging terms to facilitate understanding in this area.
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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.
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).