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Type I error | (ASQ) An incorrect decision to reject something that is acceptable, such as a statistical hypothesis or a lot of products. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
Type II error | (ASQ) An incorrect decision to accept something that is unacceptable. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
UAT | User Acceptance Testing. 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).... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
vulnerable subjects | Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hiera... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
well-being (of the trial subjects) | The physical and mental integrity of the subjects participating in a clinical trial. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
WHOdrug | WHO Drug is a dictionary of medicinal product information. It is used to identify drug names and provides information about a drug's active ingredients and its therapeutic use(s). | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
INSPECTION | CENTRAL DRUGS STANDARD CONTROL ORGANIZATION DIRECTORATE GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH & FAMILY WELFARE GOVT. OF INDIA | [
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November-2010 | CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010 | [
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SLA | State Licencing Authority CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010 | [
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Page 4 of 17 | CLINICAL TRIAL INSPECTION PROGRAMME 2 Objectives : The aims of the programme are: a. To verify GCP compliance to protect the rights, safety and well being of the subjects involved in clinical trial b. To verify the credibility and integrity of clinical trial data generated c. To verify the compliance with various regul... | [
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Page 5 of 17 | 4. Planning for Inspection: Inspection can be conducted before, during or after a clinical trial is completed. 4.1 Selection of studies: Inspection can be carried out as a routine surveillance or for any specific cause(s).Study may be selected for inspection based on, but not restricted to the following criteria: 4.1.1 | [
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Nature of study | 4.1.2 For regulatory decision based on clinical trial data 4.1.3 | [
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Complaints | 4.1.5 Vulnerability of subjects 4.1.6 Number of CT including number of subject enrolled at a | [
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particular site | 4.2 Inspection assignments: CDSCO HQ will issue instruction to the CDSCO Officers /Inspectors to conduct the inspection identifying the Clinical trial, name, address, contact number of clinical trial site, sponsor / CRO’s facilities to be inspected. It may also identify the type and purpose of the inspection and provid... | [
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Page 6 of 17 | 4.4 Scheduling the inspection: Inspection of clinical trial site would generally be pre-announced to ensure availability of the Investigator / Sub- Investigator and other personnel along with study records at the time of the inspection. The date of inspection and other arrangements would be finalised by the CDSCO Offic... | [
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Page 7 of 17 | During opening interview following main activities should be found out: 5.1.1.1 Investigator prior education and GCP experience, GCP training provided by the sponsor. 5.1.1.2 Who did what, when, where and how with respect to following: Obtaining Informed consent of subjects, Screening and admission of subjects to t... | [
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Page 8 of 17 | 5.1.2.6 Obtain list of all clinical trials performed by investigator. The list should have information such as Protocol Number Protocol Title Name of Sponsor/CRO Study date 5.1.2.7 Determine whether authority for conducting various Clinical trial related activities were delegated properly by the Investigator to... | [
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Dosage | Route of administration | [
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Frequency of dosage | Randomisation & Blinding process CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010 | [
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Page 9 of 17 | Verify whether Investigator follow the protocol as | [
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approved | Version number and EC approval of amendments 5.1.4 Subject record & Informed consent: 5.1.4.1 Review the Informed Consent Form (ICF) signed by the subjects. If the number of subjects at site is relatively small (e.g.20or less) 100% of the ICF can be reviewed. Determine the following: 5.1.4.2 whether ICF have all the ... | [
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Page 10 of 17 | 5.1.5.4 Determine whether safety/ efficacy end point data was collected and reported in accordance with the protocol; 5.1.5.5 Does medical record mentions subject ID/ name /hospital registration number / and indication that subjects are participating in a clinical trial 5.1.5.6 Whether all adverse events were reported ... | [
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Page 11 of 17 | 5.1.7 Sponsor: Verify/ determine: 5.1.7.1 Whether a clinical trial Investigators agreement has been signed for this study with the sponsor; 5.1.7.2 Whether investigator maintains copies of all reports submitted to the sponsor; 5.1.7.3 Whether all SAE are reported to sponsor within 24 hours; 5.1.7.4 Whether all CRFs wer... | [
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Page 12 of 17 | 5.1.9 Record retention: 5.1.9.1 Is adequate space available at the site for retention of | [
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documents | 5.1.9.2 Determine whether documents are maintained properly and for the period as specified and necessary measures | [
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premature | destruction; 5.1.9.3 Determine who maintained custody of the documents and means for assuring prompt action; 5.1.10 Concluding the Inspection: The inspector should conclude the inspection with final discussion with the Investigator. During discussion the inspector should explain inspection finding .The inspector may al... | [
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Page 13 of 17 | 5.2.1.8 Patient Information Sheet and Informed Consent Form 5.2.1.9 | [
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Case Record Form | 5.2.1.10 Ethics Committee approval and notifications to CDSCO 5.2.1.11 Unexpected and Serious Adverse Event Reports 5.2.1.12 | [
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Study report | 5.2.2 Organisation and personnel: 5.2.2.1 Company profile and overall structure, 5.2.2.2 Organization chart for management of the clinical trial, Structure and responsibilities for all activities involving investigational products. Departments, functions, and key | [
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Protocol | development, Investigator's brochure, Case Record Form, Informed consent form (ICF), translations and amendments ,Selection of investigators, Regulatory approval, Ethics Committee (EC) approval, Monitoring, Quality assurance Adverse Event (AE) Reporting, Data Management , Statistical Analysis, Electronic Records/Clinic... | [
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following | Authority to review and approve study documents For final evaluations and decisions in the review of | [
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study | For obtaining & reviewing adverse events and | [
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qualifications | Job description of key stake holders Verify clinical personnel training record To obtain a list of external service providers and contractors and documentation of the service they provide. Verify | [
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various | responsibilities and clinical trial related activities. CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010 | [
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Page 14 of 17 | 5.2.3 Selection and monitoring of investigators 5.2.3.1 Obtain list of all investigators along with Investigator Undertaking, Signed Investigator Agreements 5.2.3.2 Criteria for selection of sites 5.2.3.3 Information provided to sites viz. Informed consent form, Protocol, Reports/publications of previous trials, Invest... | [
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completeness | CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010 | [
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Page 15 of 17 | Which CRFs were compared to source docs? When and who verified CRFs against source data (hospital records, office charts, laboratory reports, etc.) at the study site. Form for data verification Check copy of any SOPs and guidelines for data | [
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verification | Data correction handling, Compliance to Monitoring Plan, Frequency, Follow up etc. 5.2.4 Quality Assurance (QA): 5.2.4.1 Verify SOP for QA audits and operation of quality | [
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assurance unit | 5.2.4.2 Describe how the audit and monitoring are separated 5.2.4.3 Obtain list of audited trial 5.2.5 Adverse events reporting: 5.2.5.1 Verify sponsor’s method for following up of adverse events and for dissemination of AE information to others Investigators: 5.2.5.2 Obtain list of SAE reported, Including death 5.2.5.... | [
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Authorization | application(compare to CRFs submitted) 5.2.6.3 If any subjects not included in the marketing Authorization application? Why not included? 5.2.6.4 Review of SOPS to verify compliance to assure the integrity of safety and efficacy data collected from clinical | [
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investigators | 5.2.6.5 Verify that the SOPs were followed and document any | [
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deviations | 5.2.6.6 Deviations/Data queries resolutions 5.2.6.7 | [
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Statistical processes | 5.2.6.8 Primary endpoints Compare the tabulations with CRFs | [
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Record retention | CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010 | [
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Page 16 of 17 | 5.2.7 Electronic Record and Clinical database: 5.2.7.1 Person responsible for designing and developing data | [
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base | 5.2.7.2 Can it be modified, or has it been modified? If so, by whom? 5.2.7.3 If the clinical investigator can modify it, how would the sponsor be aware of any changes? 5.2.7.4 Validation :Person responsible, Process, Documentation | [
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of process | 5.2.7.5 Error logs maintained for errors in software and systems? 5.2.7.6 Do error logs identify corrections made? 5.2.8 Data collection: Following aspects may be verified: 5.2.8.1 Responsibilities : Authorization to access the system, to enter data and to change data 5.2.8.2 Use of electronic data capture or data tran... | [
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change | 5.2.8.4 Process of data transmission from the clinical investigator | [
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to sponsor or CRO | 5.2.9 Computerized System Security: Following aspects may be verified: 5.2.9.1 Management of system access e.g. access privileges, authorization/de-authorization procedures, | [
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access controls | 5.2.9.2 Records of authorized personnel , Names, Titles. Description of their access privileges 5.2.9.3 | [
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identification | code/password combinations, tokens, biometric signature, electronic signatures, digital signatures 5.2.9.4 Data security in case of disasters, e.g., power failure 5.2.9.5 Contingency plans and backup files 5.2.9.6 Controls in place to prevent data from being altered, browsed, queried, or reported via external software ... | [
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system software | CLINICAL TRIAL INSPECTION Effective Date: 01-11-2010 | [
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Page 17 of 17 | 5.2.10 Investigational Product(IP): Following aspects may be verified: 5.2.10.1 Transferred data from central lab to sponsor 5.2.10.2 Integrity Procedures to ensure integrity of IP from manufacturing to receipt by the clinical investigator. 5.2.10.3 If IP met required release specifications by review of the Certificate... | [
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IP label | 5.2.10.7 If the test article was recalled, withdrawn, or returned? 5.2.10.8 Accountability: Following aspects may be verified: Names and addresses of clinical investigators receiving IP Shipment, date (s), quantity, batch number. Final disposition of the test article. Detailed audit if serious violations are susp... | [
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completed | participation in the clinical investigation, or the investigation was terminated. If the test article was not returned to the sponsor, describe the method of disposition and determine if adequate records were maintained. 6. Reporting of inspection The Inspection should be documented in writing in both during and after ... | [
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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL | REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL SAFETY FOR DRUGS INTENDED FOR LONG-TERM TREATMENT OF NON-LIFE-THREATENING CONDITIONS | [
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dated 27 October 1994 | 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. | [
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E1 | THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL | [
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Population Exposure | b. Situations in which there is a need to quantitate the occurrence rate of an expected specific low-frequency ADE will require a greater long-term data base. Examples would include situations where a specific serious ADE has been identified in similar drugs or where a serious event that could represent an alert event ... | [
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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL | REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN | [
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USE | ICH HARMONISED TRIPARTITE GUIDELINE CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR | [
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dated 27 October 1994 | 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. | [
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E2A | CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 27 October 1994, this guideline is recommended for adoption to the three regulatory parties to ICH I. | [
"ICH_E2A.pdf"
] | ICH_E2A.pdf | pdf | glossary.json | null | null |
INTRODUCTION | It is important to harmonise the way to gather and, if necessary, to take action on important clinical safety information arising during clinical development. Thus, agreed definitions and terminology, as well as procedures, will ensure uniform Good Clinical Practice standards in this area. The initiatives already under... | [
"ICH_E2A.pdf"
] | ICH_E2A.pdf | pdf | glossary.json | null | null |
as | interdependent, while recognising that responsibility for clinical safety within regulatory bodies and companies may reside with different departments, depending on the status of the product (investigational vs. marketed). There are two issues within the broad subject of clinical safety data management that are appropr... | [
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Post-study Events | Although such information is not routinely sought or collected by the sponsor, serious adverse events that occurred after the patient had completed a clinical study (including any protocol-required post-treatment follow-up) will possibly be reported by an investigator to the sponsor. Such cases should be regarded for e... | [
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Attachment 1 | KEY DATA ELEMENTS FOR INCLUSION IN EXPEDITED REPORTS OF SERIOUS ADVERSE DRUG REACTIONS The following list of items has its foundation in several established precedents, including those of CIOMS-I, the WHO International Drug Monitoring Centre, and various regulatory authority forms and guidelines. Some items may not be ... | [
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Initials | Other relevant identifier (clinical investigation number, for example) | [
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Gender | Age and/or date of birth | [
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Height | 2. Suspected Medicinal Product(s) Brand name as reported International Non-Proprietary Name (INN) | [
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Batch number | Indication(s) for which suspect medicinal product was prescribed or tested Dosage form and strength Daily dose and regimen (specify units - e.g., mg, ml, mg/kg) Route of administration Starting date and time of day Stopping date and time, or duration of treatment 3. Other Treatment(s) For concomitant medicinal products... | [
"ICH_E2A.pdf"
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Telephone number | Profession (speciality) 6. Administrative and Sponsor/Company Details Source of report: was it spontaneous, from a clinical investigation (provide details), from the literature (provide copy), other? Date event report was first received by sponsor/manufacturer Country in which event occurred Type of report filed to aut... | [
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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL | REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN | [
"ICH_E3.pdf"
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USE | ICH HARMONISED TRIPARTITE GUIDELINE STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS | [
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E3 | STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 30 November 1995, this guideline is recommended for adoption to the three regulatory parties to ICH | [
"ICH_E3.pdf"
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INTRODUCTION TO THE GUIDELINE.....................................................................1 | 1. TITLE PAGE...........................................................................................................3 2. SYNOPSIS...............................................................................................................3 3. TABLE OF CONTENTS FOR THE INDIVIDUAL CLINICAL STUDY REPORT................ | [
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iv | Structure and Content of Clinical Study Reports 16.1.10 Documentation of inter-laboratory standardisation methods and quality assurance procedures if used ...................................................................29 16.1.11 Publications based on the study .......................................................... | [
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ANNEX II | PRINCIPAL OR COORDINATING INVESTIGATOR(S) SIGNATURE(S) OR SPONSOR’S RESPONSIBLE MEDICAL OFFICER _______________ STUDY TITLE: ................................................................................. STUDY AUTHOR(S): ................................................................................. I have read th... | [
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ANNEX V | STUDY # (Data Set Identification) LISTING OF PATIENTS WHO DISCONTINUED THERAPY Centre: | [
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ANNEX VI | STUDY # (Data Set Identification) LISTING OF PATIENTS AND OBSERVATIONS EXCLUDED FROM EFFICACY ANALYSIS Centre: | [
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TITLE PAGE | The title page should contain the following information: − study title − name of test drug/ investigational product − indication studied − if not apparent from the title, a brief (1 to 2 sentences) description giving design (parallel, cross-over, blinding, randomised) comparison (placebo, active, dose/response), durati... | [
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SYNOPSIS | A brief synopsis (usually limited to 3 pages) that summarises the study should be provided (see Annex I of the guideline for an example of a synopsis format used in Europe). The synopsis should include numerical data to illustrate results, not just text or p-values. 3 Structure and Content of Clinical Study Reports 3. ... | [
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REPORT | The table of contents should include: − the page number or other locating information of each section, including summary tables, figures and graphs; − a list and the locations of appendices, tabulations and any case report forms provided. 4. LIST OF ABBREVIATIONS AND DEFINITION OF TERMS A list of the abbreviations, and... | [
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ETHICS | 5.1 INDEPENDENT ETHICS COMMITTEE (IEC) OR INSTITUTIONAL REVIEW BOARD (IRB) It should be confirmed that the study and any amendments were reviewed by an Independent Ethics Committee or Institutional Review Board. A list of all IECs or IRBs consulted should be given in appendix 16.1.3 and, if required by the regulatory a... | [
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INTRODUCTION | The introduction should contain a brief statement (maximum: 1 page) placing the study in the context of the development of the test drug/investigational product, relating the critical features of the study (e.g., rationale and aims, target population, treatment, duration, primary endpoints) to that development. Any gui... | [
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STUDY OBJECTIVES | A statement describing the overall purpose(s) of the study should be provided. 9. | [
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INVESTIGATIONAL PLAN | 9.1 OVERALL STUDY DESIGN AND PLAN - DESCRIPTION The overall study plan and design (configuration) of the study (e.g., parallel, cross- over) should be described briefly but clearly, using charts and diagrams as needed. If other studies used a very similar protocol, it may be useful to note this and describe any importa... | [
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ANALYSES | Any change in the conduct of the study or planned analyses (e.g., dropping a treatment group, changing the entry criteria or drug dosages, adjusting the sample size etc.) instituted after the start of the study should be described. The time(s) and reason(s) for the change(s), the procedure used to decide on the change(... | [
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STUDY PATIENTS | 10.1 DISPOSITION OF PATIENTS There should be a clear accounting of all patients who entered the study, using figures or tables in the text of the report. The numbers of patients who were randomised, and who entered and completed each phase of the study, (or each week/month of the study) should be provided, as well as t... | [
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PROTOCOL DEVIATIONS | All important deviations related to study inclusion or exclusion criteria, conduct of the trial, patient management or patient assessment should be described. In the body of the text, protocol deviations should be appropriately summarised by centre and grouped into different categories, such as: − those who entered the... | [
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DATA SETS ANALYSED | Exactly which patients were included in each efficacy analysis should be precisely defined, e.g., all patients receiving any test drugs/investigational products, all patients with any efficacy observation or with a certain minimum number of observations, only patients completing the trial, all patients with an observat... | [
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therapy | − concomitant illness at trial initiation, such as renal disease, diabetes, | [
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heart failure | − relevant previous illness − relevant previous treatment for illness treated in the study − concomitant treatment maintained, even if the dose was changed during the study, including oral contraceptive and hormone replacement therapy; treatments stopped at entry into the study period (or changed at study initiation) ¾... | [
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SAFETY EVALUATION | Analysis of safety-related data can be considered at three levels. First, the extent of exposure (dose, duration, number of patients) should be examined to determine the degree to which safety can be assessed from the study. Second, the more common adverse events, laboratory test changes etc. should be identified, clas... | [
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time of event | − Drug concentration (if known) − Duration of test drug/investigational product treatment − Concomitant treatment during study. Any abbreviations and codes should be clearly explained at the beginning of the listing or, preferably, on each page. 12.3 DEATHS, OTHER SERIOUS ADVERSE EVENTS, AND OTHER SIGNIFICANT ADVERSE E... | [
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Adverse Events | Listings, containing the same information as called for in section 12.2.4 above, should be provided for the following events. 12.3.1.1 | [
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SGPT | AP..........X # 1 # 2 | [
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70 kg | 50 kg 400mg 300mg V1* | [
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RELATED TO SAFETY | Vital signs, other physical findings, and other observations related to safety should be analysed and presented in a way similar to laboratory variables. If there is evidence of a drug effect, any dose-response or drug concentration-response relationship or relationship to patient variables (e.g., disease, demographics... | [
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SAFETY CONCLUSIONS | The overall safety evaluation of the test drug(s)/investigational product(s) should be reviewed, with particular attention to events resulting in changes of dose or need for concomitant medication, serious adverse events, events resulting in withdrawal, and deaths. Any patients or patient groups at increased risk shoul... | [
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