TRAINEE - World Health Organization

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Chapter 5 • GLP Training Manual <strong>TRAINEE</strong>S or not the study was conducted in compliance with GLP. If the study was only partially compliant, the parts that were not compliant should be indicated. Accurate Reporting and Deviations “The report should fully and accurately reflect the raw data...” This means that everything which happened during the study should be reported, but does not necessarily mean that every single item of raw data must be included in the report. The report should, however, allow the reader to follow the course of the experiment and the interpretation of the data without the need to refer to other material not included. In practice therefore, most of the individual data are included. More importantly, the report should not be a selection of the “highlights” of the study, leaving out the parts that did not “work” or where restarts were needed for one reason or another. It should certainly include any aspects where the study conduct deviated from that laid down in the protocol or SOPs, whether this is considered to have impacted on the study integrity or not. The report may include input from experts other than the study director, such as specialists within the laboratory or from outside, consultants or the sponsor. These may be included and signed by those specialists. Data supplied from outside sources should comply with GLP. If this is not the case then this should be identified in the study director’s statement. GLP requires the study director to include a statement in the report accepting responsibility for the validity of the data and confirming that the study conformed to GLP principles. Report Review After the report has been drafted, it will pass through a review stage and a QA audit. During this, modifications may be made to the report, but it is important to remember that any alterations made must be agreed and accepted by the study director. The process of approval prior to finalization may be a more distinct process in the case of a study conducted by a contract laboratory, but in any case it is designed to ensure that the report, when finalized, is unlikely to require modification. After finalization, modification can only be achieved by production of a formal amendment approved and signed by the study director and identifying the change made with a reason. 101
102 <strong>TRAINEE</strong>S Chapter 5 • GLP Training Manual ARCHIVES The archives should not be considered as simply a place for the collection and storage of “dead” materials but also as a source of information, an organizational tool, a functional entity for document distribution and compilation of summary documents, and a resource for reconstructing work if necessary. Function The archives (and archivist) provide: – A centralized, secure repository for the storage and retrieval of original scientific data, master documents and reports. – A means of controlling and documenting the distribution and modifications of archived material. – A point of control of format and completeness. – An efficient organizational tool for preparing project summary documentation (drug master file – DMF, investigational new drug – IND, new drug application – NDA, investigator brochures, etc.) made possible by a formal filing system and cross-indexation. – A unique repository for all project related work facilitating the quick and complete retrieval needed for historical reconstruction. – A defined responsibility for updating official documents in circulation (specifications, master records, protocols, SOP’s, etc.). “What” is Archived? – Study data. – Systems data. – QA files. For most studies, the core “study file” is described in the protocol. It is important that study files be pre-collated before submission in envelopes, boxes or in loose leaf or bound form. Specimens and samples are inventoried, labelled and packaged according to standard operating procedures. System generated raw data (e.g. personnel files, animal transport and arrival, HVAC maintenance) and associated quality assurance materials are submitted periodically and filed separately from the study file. Notebooks usually have mandatory tables of contents that are used for cross-indexation.
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ABOUT THIS TRAINING MANUAL . . . .
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