Privileged documents

Privileged documents must be stamped attomey/client work product. Privileged and confidential. Do not disclose, mark on, or copy ... 

Clearly mark privileged documents as such (however, merely marking documents as such does not make them privileged)... 

Selection of subjects is based on scientific objectives and not on whether the subject is privileged or vulnerable, or because of convenience (Exhibit 6.2). Inclusion and exclusion criteria are well thought out and designed solely to satisfy the scientific basis being put forward. There must be documented evidence to support the choice of selection criteria. 

The management of network user accounts is a key procedural control. This process includes the request for the addition, modification, and removal of access privileges (Part 11.10(g)). The request must be approved by the appropriate manager, documented, and submitted to the network security administration for implementation. 

Conjunction ( ) merges two policies by returning their intersection. For instance, consider an organization in which divisions share certain documents (e.g., clinical folders of patients). Access to the documents is to be allowed only if all the authorities that have a say on the document agree on it. Intuitively, while addition enforces maximum privilege, conjunction enforces minimum privilege. 

This policy document does not create or confer any rights, privileges, or benefits for or on any person, nor does it operate to bind FDA in any way... 

A bond is simply a long-term promissory note. It is a contract established between borrower and lender in a document called an indenture. A bond indenture includes a detailed description of assets that are pledged, together with any protective clauses and provisions for redemption. A trustee is appointed to look after the interest of the bondholders. The trustee is normally a commercial bank. Bonds may be issued with a call provision that enables a company to redeem its bonds at any date earlier than scheduled. Obviously, this would be an advantage to a company in times of falling interest rates. However, a company has to pay more than the par value of the bond for this privilege. The additional amount is called the bond premium. 

The true business value of an EDMS is realized to the extent that it serves as more than just the terminus for document-related activities in an enterprise. To fully realize its goals, an enterprise paperless documentation system will perform functions across the entire document life-cycle. In addition to the storage of existing documents, users with appropriate system privileges must be able to create new electronic documents from within the electronic document management system. The system must explicitly support the file formats used by the business, which typically include word processing, spreadsheet, graphics, and database files. 

The ability to track changes in a fully rationalized manner is central to achieving enterprise objectives related to efficiency, data integrity, and accountability. To facilitate control over the full development lifecycle of documents, users with appropriate system privileges must be able to check out, modify, and check in documents. 

Users with appropriate system privileges must be able to export documents in their native formats to any local or remote file systems to which they have access. Documents must be available for viewing in a standardized read-only format. Users must be able to view documents even if they do not have the native application. Users must also be able to match a printed or exported document to the original source file within the EDMS by means of unique system-generated identifiers referred to as watermarks. Watermarks must not obscure any information on the document and must be in a standardized format. Watermarks must not be obscured when the document is bound. 

Users with appropriate system privileges must be able to view documents. Typically, documents to be viewed in an EDMS are presented as read-only files, either in the authoring application or a standard immutable file format such as TIFF (Tagged Image File Format) or Adobe s portable document format (PDF). By virtue of its flexibility and platform-independence, PDF has become the storage standard in contemporary electronic document management systems. Most systems will automatically create PDF files and provide the PDF rendition in response to a user view request. 

It might be added here, that these responsibilities will certainly be transferred to their full extent to an eventual replacement Study Director. Since a permanent replacement will entail the privilege - or the burden, whichever describes the situation better - of accepting, with the signature under the statement of GLP compliance of the final report, the full responsibility for the quality, integrity and reliability of the data and the report, it will be one of the first activities of this person to assure him- or herself, as soon as practicable after taking over the new position, and preferably with the assistance of Quality Assurance personnel, of the GLP compliance in the study as it has been conducted to date. If this were to be done by means of an interim review or data audit, the results of such a GLP review should be fully documented, especially in such cases where deficiencies or deviations were found. 

Two important limitations on discovery of relevant information in patent actions are the attorney-client privilege and the work product immunity doctrine. The former protects confidential communications between lawyer and client for the purpose of securing legal advice. The latter protects documents prepared by or for counsel in connection with litigation, and counsel s mental impressions. 

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