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Clinical trials audit preparation [[electronic resource] ] : a guide for good clinical practice (GCP) inspections / / Vera Mihajlovic-Madzarevic
| Clinical trials audit preparation [[electronic resource] ] : a guide for good clinical practice (GCP) inspections / / Vera Mihajlovic-Madzarevic |
| Autore | Mihajlovic-Madzarevic Vera |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley, 2010 |
| Descrizione fisica | 1 online resource (270 p.) |
| Disciplina | 615.5/80724 |
| Soggetto topico |
Drugs - Testing - Auditing
Medical audit |
| ISBN |
0-470-92088-2
1-283-02484-5 9786613024848 0-470-57275-2 0-470-57274-4 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
CLINICAL TRIALSAUDIT PREPARATION; CONTENTS; PREFACE; INTRODUCTION; Background History on Clinical Research Standards; GLOSSARY; CHAPTER 1 GOOD CLINICAL PRACTICE AND THERAPEUTIC PRODUCT DEVELOPMENT; 1.1 Good Clinical Practice in Clinical Research; 1.1.1 Definition; 1.1.2 GCP Compliance; 1.1.3 GCP Objectives; 1.1.4 Principles of ICH GCP; Clinical Trial Conduct; Risk Assessment; Subject's Rights and Safety; Background Information; Clinical Trial Protocol; Ethics Review and Approval; Medical Care of Trial Subject; Qualifications of Clinical Trial Personnel; Informed Consent Process
Data ManagementPatient Confidentiality; Investigational Product Manufacturing, Handling, and Storage; Quality Assurance; 1.1.5 GCP Applicability; 1.2 Role of the Sponsor of a Clinical Investigation; 1.2.1 GCP: Responsibilities of a Sponsor of a Clinical Trial; 1.2.2 Essential Documents for the Clinical Trial; Retention of the Essential Documents for the Clinical Trial; Archiving of the Essential Documents for the Clinical Trial After Discontinuation of Development; Notification; Transfer of Data Ownership; Records Retention; 1.2.3 Investigator Selection; Investigator's Qualifications Resources at the Investigator's SiteProtocol and Investigator's Brochure; Agreement with the Investigator/Institution; 1.2.4 Allocation of Responsibilities; 1.2.5 Compensation to Subjects and Investigators; Compensation to Subjects for Trial-Related Injuries; Other types of Compensation to Trial Subjects; 1.2.6 Financing; 1.2.7 Notification/Submission to Regulatory Authorities; 1.2.8 Confirmation of Review by IRB/IEC; 1.2.9 Information on Investigational Products; 1.2.10 Manufacturing, Packaging, Labelling, and Coding Investigational Products Characterization, Manufacturing, and Labeling of the Investigational ProductStorage Conditions; Packaging of the Investigational Product; Coding and Decoding of the Investigational Product; Investigational Product Changes and Bioequivalence Studies; 1.2.11 Supplying and Handling Investigational Products; Supply; Investigational Product Records; 1.2.12 Record Access; Verification of Patient Consent to Record Access; 1.2.13 Safety Information; Safety Issues; Communication of Safety Issues; 1.2.14 Adverse Drug Reaction Reporting; Serious Unexpected Adverse Drug Reactions SAE Reporting ComplianceSafety Updates and Periodic Reports; 1.2.15 Monitoring; Purposes; Selection and Qualifications of Monitors; Monitoring Strategies; Monitor's Responsibilities; Monitoring Procedures; Monitoring Report; 1.2.16 Audit; Selection and Qualifications of Auditors; Auditing Procedures; Site Selection Criteria for Inspection; Reporting of Findings; Audit Certificate; 1.2.17 Noncompliance; 1.2.18 Premature Termination or Suspension of a Trial; 1.2.19 Clinical Trial/Study Reports; 1.2.20 Multicenter Trials 1.3 Role of the Institutional Review Board/Independent Ethics Committee (IRB/IEC) |
| Record Nr. | UNINA-9910140166103321 |
Mihajlovic-Madzarevic Vera
|
||
| Hoboken, N.J., : John Wiley, 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Clinical trials audit preparation [[electronic resource] ] : a guide for good clinical practice (GCP) inspections / / Vera Mihajlovic-Madzarevic
| Clinical trials audit preparation [[electronic resource] ] : a guide for good clinical practice (GCP) inspections / / Vera Mihajlovic-Madzarevic |
| Autore | Mihajlovic-Madzarevic Vera |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley, 2010 |
| Descrizione fisica | 1 online resource (270 p.) |
| Disciplina | 615.5/80724 |
| Soggetto topico |
Drugs - Testing - Auditing
Medical audit |
| ISBN |
0-470-92088-2
1-283-02484-5 9786613024848 0-470-57275-2 0-470-57274-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
CLINICAL TRIALSAUDIT PREPARATION; CONTENTS; PREFACE; INTRODUCTION; Background History on Clinical Research Standards; GLOSSARY; CHAPTER 1 GOOD CLINICAL PRACTICE AND THERAPEUTIC PRODUCT DEVELOPMENT; 1.1 Good Clinical Practice in Clinical Research; 1.1.1 Definition; 1.1.2 GCP Compliance; 1.1.3 GCP Objectives; 1.1.4 Principles of ICH GCP; Clinical Trial Conduct; Risk Assessment; Subject's Rights and Safety; Background Information; Clinical Trial Protocol; Ethics Review and Approval; Medical Care of Trial Subject; Qualifications of Clinical Trial Personnel; Informed Consent Process
Data ManagementPatient Confidentiality; Investigational Product Manufacturing, Handling, and Storage; Quality Assurance; 1.1.5 GCP Applicability; 1.2 Role of the Sponsor of a Clinical Investigation; 1.2.1 GCP: Responsibilities of a Sponsor of a Clinical Trial; 1.2.2 Essential Documents for the Clinical Trial; Retention of the Essential Documents for the Clinical Trial; Archiving of the Essential Documents for the Clinical Trial After Discontinuation of Development; Notification; Transfer of Data Ownership; Records Retention; 1.2.3 Investigator Selection; Investigator's Qualifications Resources at the Investigator's SiteProtocol and Investigator's Brochure; Agreement with the Investigator/Institution; 1.2.4 Allocation of Responsibilities; 1.2.5 Compensation to Subjects and Investigators; Compensation to Subjects for Trial-Related Injuries; Other types of Compensation to Trial Subjects; 1.2.6 Financing; 1.2.7 Notification/Submission to Regulatory Authorities; 1.2.8 Confirmation of Review by IRB/IEC; 1.2.9 Information on Investigational Products; 1.2.10 Manufacturing, Packaging, Labelling, and Coding Investigational Products Characterization, Manufacturing, and Labeling of the Investigational ProductStorage Conditions; Packaging of the Investigational Product; Coding and Decoding of the Investigational Product; Investigational Product Changes and Bioequivalence Studies; 1.2.11 Supplying and Handling Investigational Products; Supply; Investigational Product Records; 1.2.12 Record Access; Verification of Patient Consent to Record Access; 1.2.13 Safety Information; Safety Issues; Communication of Safety Issues; 1.2.14 Adverse Drug Reaction Reporting; Serious Unexpected Adverse Drug Reactions SAE Reporting ComplianceSafety Updates and Periodic Reports; 1.2.15 Monitoring; Purposes; Selection and Qualifications of Monitors; Monitoring Strategies; Monitor's Responsibilities; Monitoring Procedures; Monitoring Report; 1.2.16 Audit; Selection and Qualifications of Auditors; Auditing Procedures; Site Selection Criteria for Inspection; Reporting of Findings; Audit Certificate; 1.2.17 Noncompliance; 1.2.18 Premature Termination or Suspension of a Trial; 1.2.19 Clinical Trial/Study Reports; 1.2.20 Multicenter Trials 1.3 Role of the Institutional Review Board/Independent Ethics Committee (IRB/IEC) |
| Record Nr. | UNINA-9910813044303321 |
|
Mihajlovic-Madzarevic Vera
|
||
| Hoboken, N.J., : John Wiley, 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||