Principles and Practice of Pharmaceutical Medicine
train employees and colleagues, and implement the requirements in the standard processes; and follow the rules and provide suff ...
Observant, that is actively aware of physical sur- roundings and activities. Perceptive, that is instinctively aware of and able ...
13.4 Scope of QA activities Internal consulting QA auditors are often consulted for advice in GCP because of their broad and pro ...
time points related to a clinical trial: before a trial starts (e.g. to evaluate the adequacy of the selected site), during an o ...
aligned to the drug development program so that the audits are placed in accordance with the com- plexity and the importance of ...
auditor. The lead auditor must be nominated and responsibilities for the individual team members should be clearly assigned, con ...
Audit report ICH GCP (1995) defines an audit report as ‘A written evaluation by the sponsor’s auditor of the results of the audi ...
13.6 Brief outline of audit types Audits are conducted either for a specific trial or to evaluate an entire system in clinical r ...
site, in preparation for an investigator site audit or at trial termination and before archiving to ensure completeness of the e ...
documentation of IMP shipments, accountability, reconciliation and destruction; and randomization code break envelopes to determ ...
subjects to the datasets analyzed and to treatment groups must be traceable and comply with the ran- domization scheme and the o ...
Data management, statistics and medical writing This late phase in clinical trials ‘offers’ many opportunities to introduce erro ...
Aide-Me ́moire, 2005; Draft FDA Guidance for Industry, 2006). The systems audit should follow the route of the IMPs and verify t ...
can be accessed in the future if needed, for exam- ple, in case of regulatory inspections (ISO 9000:2005, 2005; GCP Directive, 2 ...
13.7 Conclusion QA activities are manifold and require a broad set of skills and a dependable knowledge of GCP regulations and c ...
and Experiences. Editio Cantor Verlag: Aulendorf, Germany (ISBN 3-87193-284-1). FDA Guidance for Industry: Guideline for the Mon ...
Clinical Trials on Human Subjects (PI 021-1), 16 December 2005. Accessed January 1, 2006, at http:// http://www.picscheme.org. P ...
14 The Unique Role of Over-the-Counter Medicine Paul Starkey 14.1 The expanding place of self-medication In recent years, the ro ...
availability of topical anti-fungals, it was often necessary for a woman who had already recog- nized the symptoms of the diseas ...
criteria for diagnosis, they may be as capable of rendering the diagnosis as accurately as the clinician. Even when a fully adeq ...
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