Archive management

In addition to IRB members, the head of the institute must appoint a study drug manager, a document archiving manager and administration staff for both clinical trials and the IRB. In order to handle clinical trials in such a complex structure, SOPs for conducting clinical trials must be prepared at the hospital. 

Validation Team A well-defined validation team with a well-written description of responsibilities is required and assures the adequate realization of the validation tasks. A validation team should be composed by different responsibilities responsible-of-validation team, team leader, archive manager, test coordinator, quality assurance member, tester, and witness. The responsible-for-validation team elaborates and approves the VMP, protocols, and reports. The team leader should be responsible for the computer system validation and utilization. An archive manager is responsible for the management of all computer system validation documents. The test coordinator is responsible for the computer system test and coordinates the elaboration and operation of tests for evaluating the performance of the computer system. A quality assurance member is required to periodically inspect and train the personnel and review all the validation documents. The tester is responsible for the execution of the tests required to perform the validation protocol. The witness is responsible for observing and reviewing the operations of the tester. 

Archive Management. An individual must be responsible for the archives. This person controls access to the archives, checks items in and out of the archives, and maintains these use (access) records. 

Controlled Access. Access to the physical archives (e.g., file cabinets and freezers) is controlled by locks and the archive management. Access to electronic files is controlled by secret user identification (ID) numbers. Well designed electronic data storage software records or stores the ID number of any user that enters or changes data and when that entry or change occurred. 

Legally responsible persons Manager of the facility, Study director, Head of Quality Assurance, Archiving manager USA Quality assurance, management EU Qualified Person (QP) D Qualified Person (QP), Head of Production, Head of Quality control. Quality Management, Upper management... 

Applications to and harvest of major crops such as coffee, bananas, and pineapples frequently involve procedures and equipment for which standard operating procedures have not been written. These must be identified in the planning stage, so that the Study Director or Principal Investigator can write these procedures with sufficient time to allow for review and approval. If a procedure is specific to the trial at hand, the process may be described in an addition or amendment to the protocol, but this still requires QA and management approval. In some cases, SOPs specific to a local crop are maintained at a regional site. SOPs must also be available at the site at which the raw data are archived. 

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

The validation package should be archived and must be readily retrievable. After validation is complete, these systems must be used and managed to GLP requirements. 

FieldNotes user verification can be conducted by following the SOP written by Astrix, which can be downloaded from the Astrix Web site. The SOP contains a script that is typed into the computer system. If the printout matches the SOP script, then verification is complete. A record of this must be placed in the facility archive. This verification process takes 1 h or less. For FieldNotes, calculations are not verified at the field site since the manufacturer feels that the software developer and the sponsors have performed adequate validation of these calculations previously. This may, therefore, require a visit to the sponsor or to the manufacturer to confirm that this important step of the validation process has been completed and is adequately documented. By following the Astrix SOP, the user is simply ensuring that the program operates on their system(s). The SOP script must be typed in exactly as written in order to confirm the printout accuracy. QA must ensure that the verification documentation is properly archived. Just as with any other SOP, this SOP must be approved in writing by field site management to comply with GLP. 

A well-developed records management program that defines rules by which records and documents are handled from creation to retirement is necessary for a successful electronic data archiving process. In a GLP-compliant system, records are classified by type, such as study-specific raw data, reports, personnel records, etc. Each record type has a defined retention time. 

A physical component of IT life cycle management is storage media management. Tapes, disks, and other electronic media degrade over time. Optimally, they are refreshed every 10 years. Ideally, this is part of the SOPs for the data centers and archive facilities. 

Modern NMR software covers all facets of MR applications and assists the laboratory staff and the research groups not only in the standard procedures of scan preparation, data acquisition, reconstruction and analysis, but also offers an appropriate development environment for user defined measurement methods and data analysis algorithms and provides easy-to-use tools for data management, documentation, export and archiving. The software allows the user to run complex NMR machines in a routine manner and to integrate the spectrometer into the laboratory infrastructure [7]. 

NICE, Depression Management of Depression in Primary and Secondary Care. Clinical Practice Guideline No. 23 , National Institute for Clinical Excellence www.nice.org.uk/page.aspxio = 235213 Nitzan, Uriel and Pesach Lichtenberg, Questionnaire Survey on Use of Placebo , British Medical Journal 329 (2004) 944-46 Park, Lee C. and Lino Covi, Nonblind Placebo Trial , Archives of General Psychiatry 12, no. 4 (1965) 336-45... 

This presentation demonstrates that a small minicomputer can be used to provide a full range of functions for collection and interactive reduction of data from a size-exclusion liquid chromatograph. A number of different users have collected in excess of 5000 chromatograms using this equipment. The experience gained with this system has influenced our approach to the automation of other analytical instruments. Careful attention to control paths, provision of "user friendly" access to the system functions, and careful management of the data archiving functions are crucial to the success of such efforts. 

When fresh or frozen tissue is used for proteomic analyses, the results cannot be related directly to the clinical course of diseases in a timely manner. Instead, researchers frequently reduce the number of interesting proteins to a manageable number and then attempt to use immunohistochemistry to understand the implications of proteomic changes in archival formalin-fixed, paraffin-embedded (FFPE) tissue for which the clinical course has been established.3 Unfortunately, immunohistochemistry is a semiquantitative pro-teomic method, and the choice of interesting proteins must occur without advance knowledge of the clinical course of the disease or the response to therapy. If routinely fixed and embedded archival tissues could be used for standard proteomic methods such as 2-D gel electrophoresis and mass spectrometry (MS), these powerful techniques could be used to both qualitatively and quantitatively analyze large numbers of tissues for which the clinical course has been established. However, analysis of archival FFPE tissues by... 

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