Good Practice of Clinical Drug TrialsLibrairie Luginbuhl, 2005 - 273 pages This new edition of `Good Practice' is a totally revised and expanded version of this work. It takes into account the new quality guidelines, in particular those listed in the European Union Directive, the application texts and the recommendations of the International Conference on Harmonisation (ICH). It is a practical manual to help you conduct your clinical trials. Many new or revised concepts have been included, in particular: - Rationale for each rule presented - Safety of data in clinical trials - Protection of personal data - Conflicts of interest - Measures to be taken in case of suspected fraud |
Contents
Clinical trials and quality | 1 |
2 Bad clinical practices 222224 | 34 |
4 Protection of participants | 42 |
5 Writing the investigators brochure | 58 |
6 Writing the protocol | 66 |
7 Designing the case report forms | 81 |
Monitoring a clinical trial | 94 |
Data management | 112 |
14 Adverse events | 171 |
15 Clinical study report | 192 |
Filing and archiving | 201 |
Audit of a clinical trial | 210 |
Systems audit | 225 |
Outsourcing | 232 |
20 Crisis management | 246 |
Preparation for inspection | 255 |
Computerized data processing and security | 127 |
Statistical analysis | 138 |
Using the investigational medicinal product | 143 |
Clinical laboratory data | 160 |
Management of suspected fraud | 264 |
| 270 | |
Common terms and phrases
adverse drug reaction analysis Applied Clinical Trials approval archiving assays audit clinical practices clinical research clinical research associate coding Coding dictionaries collected competent authorities compliance conduct Conference on Harmonisation consent form copy corrections CRFS data entry DDMMYY detect documents dosage Drug Information Journal Dupin-Spriet duration errors ethics committee Eudravigilance European Commission European Union evaluation example follow-up Harmonisation of technical important informed consent inspection Institutional Review Board International Conference investigational product investigator investigator's brochure involved manufacturing practices measures MedDRA medicinal products ment method monitoring multicenter trials necessary obtained on-site operation participants particular patients persons pharmaceuticals for human pharmacovigilance planned possible procedures protocol violations quality assurance record registration of pharmaceuticals regulatory report forms risk safety samples serious adverse events source-documents specific sponsor Spriet statistical studied product study drug study report subjects tion treatment validation values verification written