Principles and Practice of Pharmaceutical Medicine
diary cards, dispensing records, quality-of-life forms and so on. The CRF must allow for proper analysis of the data and proper ...
Prior to selection of a clinical study site, the sponsor/CRO must confirm and document, in the pre-study assessment visit report ...
geographically separated areas in the country, and researchers may not inform the local IRB. Normally, the sponsor/CRO will prep ...
Table 12.4 Review by ethics committees/IRBs before clinical studies begin The following items should be reviewed by ethics commi ...
study medication/device. At the beginning of a study, monitoring may be even more frequent. The most time-consuming task at the ...
Table 12.7 Information to be provided to study subjects before obtaining consent to participate in clinical studies The informat ...
process (if violations are deliberate or planned, a case of fraud should be considered!). Reporting and recording safety events ...
Table 12.8 Objectives of monitoring visits The following tasks should be undertaken by the sponsor/CRO monitor at each study sit ...
(e.g. significant trends in laboratory data or new preclinical data) that might have an impact on the risk assessment of the stu ...
To ensure that the integrity of clinical research data is maintained and that there is total agreement between the data recorded ...
sponsor/CRO cannot arbitrarily make changes of data. Archiving Systems must be in place to ensure that documents will be securel ...
subjects until the monitor has checked their condi- tion. The monitor will verify that the amount shipped matches the amount ack ...
(or masking) procedures (e.g. single-blind or dou- ble-blind) further minimize bias by ensuring that outcome judgments are not b ...
testing of medicinal products, Official Journal of the European Communities, 1991. Commission Directive 2005/28/EC of 8 April 20 ...
Part 50 – Protection of Human Subjects. http://www.access.gpo.gov/nara/cfr/waisidx_ 01/21cfr50_01.html. Part 54 – Financial Di ...
Debarment List. http://www.fda.gov/ora/ compliance_ref/debar/default.htm. Disqualified/Restricted/Assurances List for Clinical ...
uhtbin/cgisirsi/ ThuþSepþþ 7 þ13:17:28þMETþDSTþ2000/0/ 49. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceut ...
13 Quality Assurance, Quality Control and Audit Rita Hattemer-Apostel The aim of this chapter is to describe the general framewo ...
review and update of internal processes and stan- dard operating procedures (SOPs). An effective QM system for clinical research ...
Program Guidance Manual, 2006), stating: ‘Clin- ical trial quality assurance units (QAUs) are not required by regulation. Howeve ...
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