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INCLUDED IN THE TEXT
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Figures should be used to visually summarise the important results, or to clarify results that are not easily understood from tables. Important demographic, efficacy and safety data should be presented in summary figures or tables in the text of the report. However, if these become obtrusive because of size or number they should be presented here, cross-referenced to the text, along with supportive, or additional, figures, tables or listings. The following information may be presented in this section of the core clinical study report: 14.1
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DEMOGRAPHIC DATA
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Summary figures and tables 27 Structure and Content of Clinical Study Reports 14.2
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pdf
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EFFICACY DATA
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Summary figures and tables 14.3
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pdf
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SAFETY DATA
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Summary figures and tables 14.3.1 Displays of Adverse Events 14.3.2 Listings of Deaths, Other Serious and Significant Adverse Events 14.3.3 Narratives of Deaths, Other Serious and Certain Other Significant Adverse
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Events
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14.3.4 Abnormal Laboratory Value Listing (Each Patient) 15.
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ICH_E3.pdf
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REFERENCE LIST
|
A list of articles from the literature pertinent to the evaluation of the study should be provided. Copies of important publications should be attached in an appendix (16.1.11 and 16.1.12). References should be given in accordance with the internationally accepted standards of the 1979 Vancouver Declaration on "Uniform Requirements for Manuscripts Submitted to Biomedical Journals" or the system used in "Chemical Abstracts". 16.
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ICH_E3.pdf
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APPENDICES
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This section should be prefaced by a full list of all appendices available for the study report. Where permitted by the regulatory authority, some of the following appendices need not be submitted with the report but need to be provided only on request. The applicant should therefore clearly indicate those appendices that are submitted with the report. N.B. In order to have appendices available on request, they should be finalised by the time of filing of the submission. 16.1
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STUDY INFORMATION
|
16.1.1 Protocol and protocol amendments 16.1.2 Sample case report form (unique pages only) 16.1.3 List of IECs or IRBs (plus the name of the committee Chair if required by the regulatory authority) - Representative written information for patient and
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"ICH_E3.pdf"
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sample consent forms
|
16.1.4 List and description of investigators and other important participants in the study, including brief (1 page) CVs or equivalent summaries of training and experience relevant to the performance of the clinical study 16.1.5 Signatures of principal or coordinating investigator(s) or sponsor’s responsible medical officer, depending on the regulatory authority's requirement 16.1.6 Listing of patients receiving test drug(s)/investigational product(s) from specific batches, where more than one batch was used 28 Structure and Content of Clinical Study Reports 16.1.7 Randomisation scheme and codes (patient identification and treatment assigned) 16.1.8 Audit certificates (if available) (see Annex IVa and IVb of the guideline) 16.1.9 Documentation of statistical methods 16.1.10 Documentation of inter-laboratory standardisation methods and quality assurance procedures if used 16.1.11 Publications based on the study 16.1.12 Important publications referenced in the report 16.2. PATIENT DATA LISTINGS 16.2.1 Discontinued patients 16.2.2 Protocol deviations 16.2.3 Patients excluded from the efficacy analysis 16.2.4 Demographic data 16.2.5 Compliance and/or drug concentration data (if available) 16.2.6 Individual efficacy response data 16.2.7 Adverse event listings (each patient) 16.2.8. Listing of individual laboratory measurements by patient, when required by regulatory authorities 16.3
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CASE REPORT FORMS
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16.3.1 CRFs for deaths, other serious adverse events and withdrawals for AE 16.3.2 Other CRFs submitted 16.4. INDIVIDUAL PATIENT DATA LISTINGS (US ARCHIVAL LISTINGS) 29 Structure and Content of Clinical Study Reports
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ANNEX I
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Name of Sponsor/Company: Individual Study Table
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pdf
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of the Dossier
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(For National Authority Use Only) Name of Finished Product: Volume: Name of Active Ingredient: Page: Criteria for evaluation: Efficacy: Safety: Statistical methods:
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SUMMARY - CONCLUSIONS
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EFFICACY RESULTS: SAFETY RESULTS: CONCLUSION: Date of the report: 31 Structure and Content of Clinical Study Reports
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MEDICAL OFFICER
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AFFILIATION: _______________________ ______________________________ ______________________________ DATE: _______________________ 32 Structure and Content of Clinical Study Reports
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ANNEX III a
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STUDY DESIGN AND SCHEDULE OF ASSESSMENTS
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pdf
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Run-in
|
5 mg 10 mg 5 mg 10 mg Test Drug/
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pdf
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Product B
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5 mg 10 mg 5 mg 10 mg
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Visit
|
-2 (-3) 1 0 2 3 3 6 4 9 5 12 6
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1 = 14-20 days after visit 1
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2 = 1-7 days after the first exercise test 33 Structure and Content of Clinical Study Reports 34
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ANNEX III b
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STUDY DESIGN AND SCHEDULE OF ASSESSMENTS
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Dose 1
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1 2 3 4 R 11
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pdf
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Dose 3
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(7d) (7d) (7d) (7d) 5 6 7 8 9
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"ICH_E3.pdf"
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pdf
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Study Week
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-2 -1 0 1 2 3 4 5 6 8
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ICH_E3.pdf
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pdf
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PATIENTS RECEIVING
|
DOUBLE-BLIND MEDICATION N = 340
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pdf
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Withdrawn
|
ADVERSE EVENT (20) UNSAT. RESPONSE (32) etc. ...... etc. ...... 36 Structure and Content of Clinical Study Reports
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Screening Failures
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Reasons: ___________ (300) ___________ (271) ___________ N= 8
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ANY MEDICATION
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Reasons: _________ (2) _________ (4) _________ (2) N= 1724
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Placebo
|
*The specific reaction leading to discontinuation (Repeat for other centres) 37 Structure and Content of Clinical Study Reports
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Reference Tables
|
Summary: 38 Structure and Content of Clinical Study Reports
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pdf
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ANNEX VII
|
STUDY # (Data Set Identification) NUMBER OF PATIENTS EXCLUDED FROM EFFICACY ANALYSIS Test Drug/Investigational Product N =
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Total
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Similar tables should be prepared for the other treatment groups. 39 Structure and Content of Clinical Study Reports
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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
|
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN
|
[
"ICH_E6.pdf"
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ICH_E6.pdf
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pdf
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USE
|
ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R1) Current Step 4 version
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ICH_E6.pdf
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pdf
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dated 10 June 1996
|
(including the Post Step 4 corrections) This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. E6(R1)
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pdf
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E6
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Approval by the Steering Committee of Post-Step 4 editorial corrections. 10
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June
|
1996 E6(R1) GUIDELINE FOR GOOD CLINICAL PRACTICE ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 1 May 1996, this guideline is recommended for adoption to the three regulatory parties to ICH (This document includes the Post Step 4 corrections agreed by the Steering Committee on 10 June 1996)
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Guideline for Good Clinical Practice
|
8.4 After Completion or Termination of the Trial After completion or termination of the trial, all of the documents identified in sections 8.2 and 8.3 should be in the file together with the
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iii
|
GUIDELINE FOR GOOD CLINICAL PRACTICE
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Introduction
|
Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. Essential Documents also serve a number of other important purposes. Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a trial by the investigator, sponsor and monitor. These documents are also the ones which are usually audited by the sponsor's independent audit function and inspected by the regulatory authority(ies) as part of the process to confirm the validity of the trial conduct and the integrity of data collected. The minimum list of essential documents which has been developed follows. The various documents are grouped in three sections according to the stage of the trial during which they will normally be generated: 1) before the clinical phase of the trial commences, 2) during the clinical conduct of the trial, and 3) after completion or termination of the trial. A description is given of the purpose of each document, and whether it should be filed in either the investigator/institution or sponsor files, or both. It is acceptable to combine some of the documents, provided the individual elements are readily identifiable. Trial master files should be established at the beginning of the trial, both at the investigator/institution’s site and at the sponsor's office. A final close-out of a trial can only be done when the monitor has reviewed both investigator/institution and sponsor files and confirmed that all necessary documents are in the appropriate files. Any or all of the documents addressed in this guideline may be subject to, and should be available for, audit by the sponsor’s auditor and inspection by the regulatory authority(ies). 41 Guideline for Good Clinical Practice 8.2 Before the Clinical Phase of the Trial Commences During this planning stage the following documents should be generated and should be on file before the trial formally starts
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GLOSSARY
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1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 1.2 Adverse Event (AE) Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 1.3 Amendment (to the protocol) See Protocol Amendment. 1.4 Applicable Regulatory Requirement(s) Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. 1.5 Approval (in relation to Institutional Review Boards) The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. 1.6
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Audit
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28 Guideline for Good Clinical Practice If or when sponsors perform audits, as part of implementing quality assurance, they should consider: 5.19.1 Purpose The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements. 5.19.2 Selection and Qualification of Auditors (a) The sponsor should appoint individuals, who are independent of the clinical trials/systems, to conduct audits. (b) The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly. An auditor’s qualifications should be documented. 5.19.3 Auditing Procedures (a) The sponsor should ensure that the auditing of clinical trials/systems is conducted in accordance with the sponsor's written procedures on what to audit, how to audit, the frequency of audits, and the form and content of audit reports. (b) The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial to submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the level of risks to the trial subjects, and any identified problem(s). (c) The observations and findings of the auditor(s) should be documented. (d) To preserve the independence and value of the audit function, the regulatory authority(ies) should not routinely request the audit reports. Regulatory authority(ies) may seek access to an audit report on a case by case basis when evidence of serious GCP non-compliance exists, or in the course of legal proceedings. (e) When required by applicable law or regulation, the sponsor should provide an audit certificate. 5.20
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Audit Certificate
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A declaration of confirmation by the auditor that an audit has taken place. 1.8
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Audit Report
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A written evaluation by the sponsor's auditor of the results of the audit. 2 Guideline for Good Clinical Practice 1.9
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Audit Trail
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Documentation that allows reconstruction of the course of events. 1.10 Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). 1.11 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. 1.12 Clinical Trial/Study 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. 1.13 Clinical Trial/Study Report 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 (see the ICH Guideline for Structure and Content of Clinical Study Reports). 1.14 Comparator (Product) An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. 1.15 Compliance (in relation to trials) Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements. 1.16
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Confidentiality
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Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. 1.17
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Contract
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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. 1.18 Coordinating Committee A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. 3 Guideline for Good Clinical Practice 1.19 Coordinating Investigator An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial. 1.20 Contract Research Organization (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. 1.21
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Direct Access
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Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor’s proprietary information. 1.22
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Documentation
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All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. 1.23
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Essential Documents
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Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see 8. Essential Documents for the Conduct of a Clinical Trial). 1.24 Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. 1.25 Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee) An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. 1.26
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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. 1.27 Independent Ethics Committee (IEC) An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favourable 4 Guideline for Good Clinical Practice opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline. 1.28
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Informed Consent
|
A process by which a subject voluntarily confirms his or her willingness to participate in a particular 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. 1.29
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Inspection
|
The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). 1.30 Institution (medical) Any public or private entity or agency or medical or dental facility where clinical trials are conducted. 1.31 Institutional Review Board (IRB) An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. 1.32 Interim Clinical Trial/Study Report A report of intermediate results and their evaluation based on analyses performed during the course of a trial. 1.33 Investigational Product A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. 1.34
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INVESTIGATOR
|
4.1 Investigator's Qualifications and Agreements 4.1.1 The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies). 4.1.2 The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor. 4.1.3 The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements. 4.1.4 The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies). 4.1.5 The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties. 4.2
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Monitoring
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5.18.1 Purpose The purposes of trial monitoring are to verify that: (a) The rights and well-being of human subjects are protected. (b) The reported trial data are accurate, complete, and verifiable from source documents. (c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s). 5.18.2 Selection and Qualifications of Monitors (a) Monitors should be appointed by the sponsor. (b) Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. A monitor’s qualifications should be documented. (c) Monitors should be thoroughly familiar with the investigational product(s), 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 requirement(s). 5.18.3 Extent and Nature of Monitoring The sponsor should ensure that the trials are adequately monitored. The sponsor should determine the appropriate extent and nature of monitoring. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial. In general there is a need for on-site monitoring, before, during, and after the trial; however in exceptional circumstances the sponsor may determine that central monitoring in conjunction with procedures such as investigators’ training and meetings, and extensive written guidance can assure appropriate conduct of the trial in accordance with GCP. Statistically controlled sampling may be an acceptable method for selecting the data to be verified. 5.18.4 Monitor's Responsibilities 26 Guideline for Good Clinical Practice The monitor(s) in accordance with the sponsor’s requirements should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site: (a) Acting as the main line of communication between the sponsor and the investigator. (b) Verifying that the investigator has adequate qualifications and resources (see 4.1, 4.2, 5.6) and remain adequate throughout the trial period, that facilities, including laboratories, equipment, and staff, are adequate to safely and properly conduct the trial and remain adequate throughout the trial period. (c) Verifying, for the investigational product(s): (i) That storage times and conditions are acceptable, and that supplies are sufficient throughout the trial. (ii) That the investigational product(s) are supplied only to subjects who are eligible to receive it and at the protocol specified dose(s). (iii) That subjects are provided with necessary instruction on properly using, handling, storing,
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Monitoring Report
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A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs. 1.40
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Multicentre Trial
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A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. 1.41
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Nonclinical Study
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Biomedical studies not performed on human subjects. 1.42 Opinion (in relation to Independent Ethics Committee) The judgement and/or the advice provided by an Independent Ethics Committee (IEC). 1.43 Original Medical Record See Source Documents. 1.44
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Protocol
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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. 1.45
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Protocol Amendment
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A written description of a change(s) to or formal clarification of a protocol. 1.46 Quality Assurance (QA) All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s). 6 Guideline for Good Clinical Practice 1.47 Quality Control (QC) The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. 1.48
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Randomization
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The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. 1.49 Regulatory Authorities Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities. 1.50 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) Any untoward medical occurrence that at any dose: - results in death, - is life-threatening, - requires inpatient hospitalization or prolongation of existing hospitalization, - results in persistent or significant disability/incapacity,
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or
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corrections made to CRF after initial data were
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Source Data
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All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). 1.52
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Source Documents
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Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial). 1.53
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Sponsor
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8.4.7 FINAL REPORT BY INVESTIGATOR TO IRB/IEC WHERE REQUIRED, AND WHERE APPLICABLE, TO THE REGULATORY AUTHORITY(IES) To document completion of the trial
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Sponsor-Investigator
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An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. 1.55 Standard Operating Procedures (SOPs) Detailed, written instructions to achieve uniformity of the performance of a specific function. 1.56
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Subinvestigator
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Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also Investigator. 1.57 Subject/Trial Subject An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. 1.58 Subject Identification Code A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data. 1.59
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Trial Site
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The location(s) where trial-related activities are actually conducted. 1.60 Unexpected Adverse Drug Reaction 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) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 1.61
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Procedures
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The IRB/IEC should establish, document in writing, and follow its procedures, which should include: 3.3.1 Determining its composition (names and qualifications of the members) and the authority under which it is established. 3.3.2 Scheduling, notifying its members of, and conducting its meetings. 3.3.3 Conducting initial and continuing review of trials. 3.3.4 Determining the frequency of continuing review, as appropriate. 3.3.5 Providing, according to the applicable regulatory requirements, expedited review and approval/favourable opinion of minor change(s) in ongoing trials that have the approval/favourable opinion of the IRB/IEC. 3.3.6 Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval/favourable opinion of the trial. 3.3.7 Specifying that no deviations from, or changes of, the protocol should be initiated without prior written IRB/IEC approval/favourable opinion of an appropriate amendment, except when necessary to eliminate immediate hazards to the subjects or when the change(s) involves only logistical or 11 Guideline for Good Clinical Practice administrative aspects of the trial (e.g., change of monitor(s), telephone number(s)) (see 4.5.2). 3.3.8 Specifying that the investigator should promptly report to the IRB/IEC: (a) Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects (see 3.3.7, 4.5.2, 4.5.4). (b) Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial (see 4.10.2). (c) All adverse drug reactions (ADRs) that are both serious and unexpected. (d) New information that may affect adversely the safety of the subjects or the conduct of the trial. 3.3.9
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the
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investigator’s trial staff ( may be combined with 8.2.19)
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Records
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The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 3 years after completion of the trial and make them available upon request from the regulatory authority(ies). The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists. 4.
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Adequate Resources
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12 Guideline for Good Clinical Practice 4.2.1 The investigator should be able to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period. 4.2.2 The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period. 4.2.3 The investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely. 4.2.4 The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions. 4.3 Medical Care of Trial Subjects 4.3.1 A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions. 4.3.2
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regulatory
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authority(ies). 29 Guideline for Good Clinical Practice 5.21 Premature Termination or Suspension of a Trial If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions, and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension. The IRB/IEC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor or by the investigator/institution, as specified by the applicable regulatory requirement(s). 5.22 Clinical Trial/Study Reports Whether the trial is completed or prematurely terminated, the sponsor should ensure that the clinical trial reports are prepared and provided to the regulatory agency(ies) as required by the applicable regulatory requirement(s). The sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of the ICH Guideline for Structure and Content of Clinical Study Reports. (NOTE: The ICH Guideline for Structure and Content of Clinical Study Reports specifies that abbreviated study reports may be acceptable in certain cases.) 5.23
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Records and Reports
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4.9.1 The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports. 4.9.2 Data reported on the CRF, that are derived from source documents, should be consistent with the source documents or the discrepancies should be explained. 4.9.3 Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (i.e. an audit trail should be maintained); this applies to both written and electronic changes or corrections (see 5.18.4 (n)). Sponsors should provide guidance to investigators and/or the investigators' designated representatives on making such corrections. Sponsors should have written procedures to assure that changes or corrections in CRFs made by sponsor's designated representatives are documented, are necessary, and are endorsed by the investigator. The investigator should retain records of the changes and corrections. 4.9.4 The investigator/institution should maintain the trial documents as specified in Essential Documents for the Conduct of a Clinical Trial (see 8.) and as
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Progress Reports
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4.10.1 The investigator should submit written summaries of the trial status to the IRB/IEC annually, or more frequently, if requested by the IRB/IEC. 4.10.2 The investigator should promptly provide written reports to the sponsor, the IRB/IEC (see 3.3.8) and, where applicable, the institution on any changes significantly affecting the conduct of the trial, and/or increasing the risk to subjects. 4.11
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Safety Reporting
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4.11.1 All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should be followed promptly by detailed, written reports. The immediate and follow-up reports should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification numbers, and/or addresses. The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the IRB/IEC. 4.11.2 Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol. 4.11.3 For reported deaths, the investigator should supply the sponsor and the IRB/IEC with any additional requested information (e.g., autopsy reports and terminal medical reports). 4.12 Premature Termination or Suspension of a Trial If the trial is prematurely terminated or suspended for any reason, the investigator/institution should promptly inform the trial subjects, should assure appropriate therapy and follow-up for the subjects, and, where required by the applicable regulatory requirement(s), should inform the regulatory authority(ies). In addition: 4.12.1 If the investigator terminates or suspends a trial without prior agreement of the sponsor, the investigator should inform the institution where applicable, and the investigator/institution should promptly inform the sponsor and the IRB/IEC, and should provide the sponsor and the IRB/IEC a detailed written explanation of the termination or suspension. 19 Guideline for Good Clinical Practice 4.12.2 If the sponsor terminates or suspends a trial (see 5.21), the investigator should
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Medical Expertise
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The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose. 5.4
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Trial Design
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The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. A description of the trial design, should include: 6.4.1 A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the trial. 6.4.2 A description of the type/design of trial to be conducted (e.g. double-blind, placebo-controlled, parallel design) and a schematic diagram of trial design, procedures and stages. 6.4.3 A description of the measures taken to minimize/avoid bias, including: (a) Randomization. (b) Blinding. 6.4.4 A description of the trial treatment(s) and the dosage and dosage regimen of the investigational product(s). Also include a description of the dosage form, packaging, and labelling of the investigational product(s). 6.4.5 The expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up, if any. 6.4.6 A description of the "stopping rules" or "discontinuation criteria" for individual subjects, parts of trial and entire trial. 31 Guideline for Good Clinical Practice 6.4.7 Accountability procedures for the investigational product(s), including the placebo(s) and comparator(s), if any. 6.4.8 Maintenance of trial treatment randomization codes and procedures for breaking codes. 6.4.9 The identification of any data to be recorded directly on the CRFs (i.e. no prior written or electronic record of data), and to be considered to be source data. 6.5 Selection and Withdrawal of Subjects 6.5.1 Subject inclusion criteria. 6.5.2 Subject exclusion criteria. 6.5.3
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Financing
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The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator/institution. 5.10 Notification/Submission to Regulatory Authority(ies) Before initiating the clinical trial(s), the sponsor (or the sponsor and the investigator, if required by the applicable regulatory requirement(s)) should submit any required application(s) to the appropriate authority(ies) for review, acceptance, and/or permission (as required by the applicable regulatory requirement(s)) to begin the trial(s). Any notification/submission should be dated and contain sufficient information to identify the protocol. 5.11 Confirmation of Review by IRB/IEC 5.11.1 The sponsor should obtain from the investigator/institution: (a) The name and address of the investigator's/institution’s IRB/IEC. (b) A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws and regulations. (c) Documented IRB/IEC approval/favourable opinion and, if requested by the sponsor, a current copy of protocol, written informed consent form(s) and any other written information to be provided to subjects, subject recruiting procedures, and documents related to payments and compensation available to the subjects, and any other documents that the IRB/IEC may have requested. 5.11.2 If the IRB/IEC conditions its approval/favourable opinion upon change(s) in any aspect of the trial, such as modification(s) of the protocol, written informed consent form and any other written information to be provided to subjects, and/or
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and
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absorption, plasma protein binding, distribution, and elimination). − Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference dosage form. − Population subgroups (e.g., gender, age, and impaired organ function). − Interactions (e.g., product-product interactions and effects of food). − Other pharmacokinetic data (e.g., results of population studies performed within clinical trial(s). (b) Safety and Efficacy A summary of information should be provided about the investigational product's/products' (including metabolites, where appropriate) safety, pharmacodynamics, efficacy, and dose response that were obtained from preceding trials in humans (healthy volunteers and/or patients). The implications of this information should be discussed. In cases where a number of clinical trials have been completed, the use of summaries of safety and efficacy across multiple trials by indications in subgroups may provide a clear presentation of the data. Tabular summaries of adverse drug reactions for all the clinical trials (including those for all the studied indications) would be useful. Important differences in adverse drug 37 Guideline for Good Clinical Practice reaction patterns/incidences across indications or subgroups should be discussed. The IB should provide a description of the possible risks and adverse drug reactions to be anticipated on the basis of prior experiences with the product under investigation and with related products. A description should also be provided of the precautions or special monitoring to be done as part of the investigational use of the product(s). (c) Marketing Experience The IB should identify countries where the investigational product has been marketed or approved. Any significant information arising from the marketed use should be summarised (e.g., formulations, dosages, routes of administration, and adverse product reactions). The IB should also identify all the countries where the investigational product did not receive approval/registration
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Record Access
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5.15.1 The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection. 5.15.2 The sponsor should verify that each subject has consented, in writing, to direct access to his/her original medical records for trial-related monitoring, audit, IRB/IEC review, and regulatory inspection. 5.16
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Safety Information
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5.16.1 The sponsor is responsible for the ongoing safety evaluation of the investigational product(s). 5.16.2 The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies) of findings that could affect adversely the 25 Guideline for Good Clinical Practice safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's approval/favourable opinion to continue the trial. 5.17 Adverse Drug Reaction Reporting 5.17.1 The
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investigator(s)/institutions(s), to the IRB(s)/IEC(s), where required, and to the regulatory authority(ies) of all adverse drug reactions (ADRs) that are both serious and unexpected. 5.17.2 Such expedited reports should comply with the applicable regulatory requirement(s) and with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. 5.17.3 The sponsor should submit to the regulatory authority(ies) all safety updates and periodic reports, as required by applicable regulatory requirement(s). 5.18
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Noncompliance
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5.20.1 Noncompliance with the protocol, SOPs, GCP, and/or applicable regulatory requirement(s) by an investigator/institution, or by member(s) of the sponsor's staff should lead to prompt action by the sponsor to secure compliance. 5.20.2 If the monitoring and/or auditing identifies serious and/or persistent noncompliance on the part of an investigator/institution, the sponsor should terminate the investigator's/institution’s participation in the trial. When an investigator's/institution’s
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Multicentre Trials
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For multicentre trials, the sponsor should ensure that: 5.23.1 All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies), and given approval/favourable opinion by the IRB/IEC. 5.23.2 The CRFs are designed to capture the required data at all multicentre trial sites. For those investigators who are collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional data. 5.23.3 The responsibilities of coordinating investigator(s) and the other participating investigators are documented prior to the start of the trial. 5.23.4 All investigators are given instructions on following the protocol, on complying with a uniform set of standards for the assessment of clinical and laboratory findings, and on completing the CRFs. 5.23.5 Communication between investigators is facilitated. 6. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) The contents of a trial protocol should generally include the following topics. However, site specific information may be provided on separate protocol page(s), or addressed in a separate agreement, and some of the information listed below may be contained in other protocol referenced documents, such as an Investigator’s Brochure. 6.1
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General Information
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6.1.1 Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the amendment number(s) and date(s). 6.1.2 Name and address of the sponsor and monitor (if other than the sponsor). 6.1.3 Name and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for the sponsor. 6.1.4 Name, title, address, and telephone number(s) of the sponsor's medical expert (or dentist when appropriate) for the trial. 30 Guideline for Good Clinical Practice 6.1.5 Name and title of the investigator(s) who is (are) responsible for conducting the trial, and the address and telephone number(s) of the trial site(s). 6.1.6 Name, title, address, and telephone number(s) of the qualified physician (or dentist, if applicable), who is responsible for all trial-site related medical (or dental) decisions (if other than investigator). 6.1.7 Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the trial. 6.2 Background Information 6.2.1 Name and description of the investigational product(s). 6.2.2 A summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial. 6.2.3 Summary of the known and potential risks and benefits, if any, to human subjects. 6.2.4 Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s). 6.2.5 A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s). 6.2.6 Description of the population to be studied. 6.2.7 References to literature and data that are relevant to the trial, and that provide background for the trial. 6.3 Trial Objectives and Purpose A detailed description of the objectives and the purpose of the trial. 6.4
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product
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(s ) pharmacological class and its expected position within this class (e.g. advantages), the rationale for performing research with the investigational product(s), and the anticipated prophylactic, therapeutic, or diagnostic indication(s). Finally, the introductory statement should provide the general approach to be followed in evaluating the investigational product. 7.3.4 Physical, Chemical, and Pharmaceutical Properties and Formulation A description should be provided of the investigational product substance(s) (including the chemical and/or structural formula(e)), and a brief summary should be given of the relevant physical, chemical, and pharmaceutical properties. To permit appropriate safety measures to be taken in the course of the trial, a description of the formulation(s) to be used, including excipients, should be provided and justified if clinically relevant. Instructions for the storage and handling of the dosage form(s) should also be given. Any structural similarities to other known compounds should be mentioned. 35 Guideline for Good Clinical Practice 7.3.5 Nonclinical Studies Introduction:
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Treatment of Subjects
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6.6.1 The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up period(s) for subjects for each investigational product treatment/trial treatment group/arm of the trial. 6.6.2 Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial. 6.6.3 Procedures for monitoring subject compliance. 6.7 Assessment of Efficacy 6.7.1 Specification of the efficacy parameters. 6.7.2 Methods and timing for assessing, recording, and analysing of efficacy parameters. 6.8
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Assessment of Safety
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6.8.1 Specification of safety parameters. 6.8.2 The methods and timing for assessing, recording, and analysing safety parameters. 6.8.3 Procedures for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses. 6.8.4 The type and duration of the follow-up of subjects after adverse events. 6.9
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Statistics
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32 Guideline for Good Clinical Practice 6.9.1 A description of the statistical methods to be employed, including timing of any planned interim analysis(ses). 6.9.2 The number of subjects planned to be enrolled. In multicentre trials, the numbers of enrolled subjects projected for each trial site should be specified. Reason for choice of sample size, including reflections on (or calculations of) the power of the trial and clinical justification. 6.9.3 The level of significance to be used. 6.9.4 Criteria for the termination of the trial. 6.9.5 Procedure for accounting for missing, unused, and spurious data. 6.9.6 Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s) from the original statistical plan should be described and justified in protocol and/or in the final report, as appropriate). 6.9.7 The selection of subjects to be included in the analyses (e.g. all randomized subjects, all dosed subjects, all eligible subjects, evaluable subjects). 6.10 Direct Access to Source Data/Documents The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspection(s), providing direct access to source data/documents. 6.11 Quality Control and Quality Assurance 6.12
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[
"ICH_E6.pdf"
] |
ICH_E6.pdf
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pdf
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glossary.json
| null | null |
Ethics
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Description of ethical considerations relating to the trial. 6.13 Data Handling and Record Keeping 6.14 Financing and Insurance Financing and insurance if not addressed in a separate agreement. 6.15
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[
"ICH_E6.pdf"
] |
ICH_E6.pdf
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pdf
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glossary.json
| null | null |
Publication Policy
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Publication policy, if not addressed in a separate agreement. 6.16
|
[
"ICH_E6.pdf"
] |
ICH_E6.pdf
|
pdf
|
glossary.json
| null | null |
Supplements
|
(NOTE: Since the protocol and the clinical trial/study report are closely related, further relevant information can be found in the ICH Guideline for Structure and Content of Clinical Study Reports.) 33 Guideline for Good Clinical Practice 7. INVESTIGATOR’S BROCHURE 7.1
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[
"ICH_E6.pdf"
] |
ICH_E6.pdf
|
pdf
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glossary.json
| null | null |
Title Page
|
This should provide the sponsor's name, the identity of each investigational product (i.e., research number, chemical or approved generic name, and trade name(s) where legally permissible and desired by the sponsor), and the release date. It is also suggested that an edition number, and a reference to the number and date of the edition it supersedes, be provided. An example is given in Appendix 1. 7.2.2 Confidentiality Statement
|
[
"ICH_E6.pdf"
] |
ICH_E6.pdf
|
pdf
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glossary.json
| null | null |
Summary
|
A brief summary (preferably not exceeding two pages) should be given,
|
[
"ICH_E6.pdf"
] |
ICH_E6.pdf
|
pdf
|
glossary.json
| null | null |
significant
|
physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information available that is relevant to the stage of clinical development of the investigational product. 7.3.3
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[
"ICH_E6.pdf"
] |
ICH_E6.pdf
|
pdf
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glossary.json
| null | null |
nonclinical
|
pharmacology, toxicology, pharmacokinetic, and investigational product metabolism studies should be provided in summary form. This summary should address the methodology used, the results, and a discussion of the relevance of the findings to the investigated therapeutic and the possible unfavourable and unintended effects in humans. The information provided may include the following, as appropriate, if known/available: • Species tested • Number and sex of animals in each group • Unit dose (e.g., milligram/kilogram (mg/kg)) • Dose interval • Route of administration • Duration of dosing • Information on systemic distribution • Duration of post-exposure follow-up • Results, including the following aspects: − Nature and frequency of pharmacological or toxic effects − Severity or intensity of pharmacological or toxic effects − Time to onset of effects − Reversibility of effects − Duration of effects − Dose response Tabular format/listings should be used whenever possible to enhance the clarity of the presentation. The following sections should discuss the most important findings from the studies, including the dose response of observed effects, the relevance to humans, and any aspects to be studied in humans. If applicable, the effective and nontoxic dose findings in the same animal species should be compared (i.e., the therapeutic index should be discussed). The relevance of this information to the proposed human dosing should be addressed. Whenever possible, comparisons should be made in terms of blood/tissue levels rather than on a mg/kg basis. (a) Nonclinical Pharmacology A summary of the pharmacological aspects of the investigational product and, where appropriate, its significant metabolites studied in animals, should be included. Such a summary should incorporate studies that assess potential therapeutic activity (e.g. efficacy models, receptor binding, and specificity) as well as those that assess safety (e.g., special studies to assess pharmacological actions other than the intended therapeutic effect(s)). 36 Guideline for Good Clinical Practice (b) Pharmacokinetics and Product Metabolism in Animals A summary of the pharmacokinetics and biological transformation and disposition of the investigational product in all species studied should be given. The discussion of the findings should address the absorption and the local and systemic bioavailability of the investigational product and its metabolites,
|
[
"ICH_E6.pdf"
] |
ICH_E6.pdf
|
pdf
|
glossary.json
| null | null |
8.2.2
|
SIGNED PROTOCOL AND AMENDMENTS, IF ANY, AND SAMPLE CASE REPORT FORM (CRF)
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[
"ICH_E6.pdf"
] |
ICH_E6.pdf
|
pdf
|
glossary.json
| null | null |
SUBJECT
|
- INFORMED CONSENT FORM (including all applicable translations) To document the informed consent
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[
"ICH_E6.pdf"
] |
ICH_E6.pdf
|
pdf
|
glossary.json
| null | null |
- ANY OTHER WRITTEN INFORMATION
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To document that subjects will be given appropriate written information (content and wording) to support their ability to give fully
|
[
"ICH_E6.pdf"
] |
ICH_E6.pdf
|
pdf
|
glossary.json
| null | null |
- ADVERTISEMENT FOR SUBJECT
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RECRUITMENT (if used) To document that recruitment measures are appropriate and not coercive
|
[
"ICH_E6.pdf"
] |
ICH_E6.pdf
|
pdf
|
glossary.json
| null | null |
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