Definitions

Term Definition
A
Active Directory The Active Directory is a Windows-based directory service. It stores information about the network and makes this information available to users and network administrators. It gives users access to permitted resources anywhere on the network using a single logon process. Using an Active Directory to store user information provides integrated authentication and centralized user management. The Active Directory contains the user accounts, computer accounts, groups and all related credential information used by windows and SharePoint.
Artifact A type of document in the eTMF.
Artifact Name Identifies the tertiary level of classification for a document. The Artifact Name is a subset of the Domain Name.
Audit Log A historical record of changes to a document or item that captures the ID of the person making the change, the date and time of the change, and the reason for the change.
Authentication Authentication is the process of determining who a user is and whether the User-ID and password provided are valid. It is the validation of a user’s logon credentials.
Authorization Authorization is the process of determining what a user has a sufficient permission level to do or to access.
Auto Document Naming Auto Document Naming allows the user to configure a schema that will be used to automatically rename documents and list items. Auto Document Naming adds structure and provides conformity to documentation.
B
Breadcrumbs A form of text-based Web Site Navigation that displays a series of sequential links so that users can see where the current Web page is located within the Web site and how the user navigated to that location. The navigation breadcrumb is displayed at the top of the page on all pages.
C
Check Out and Check In The SharePoint Check Out and Check In capability provides multiple benefits that increase security and add clarity to document content and/or metadata modification. They include:
  • Avoiding conflict with other users who are working in the same library.
  • Maintaining version control. Without check out/check in enabled, a new version is created each time you save the document. With check out/check in enabled, a new version is not created until you check the document back in.
  • Prompting you to provide comments defining the modifications, thereby making versioning more meaningful.
  • Identifying which documents are currently being edited and who is doing the editing.
  • Allowing you to evaluate your changes prior to making them available to others. While a file is checked out to you, the changes that you make are not visible to others until you check the file back in. If you do not wish to save the changes, simply discard the check out.
  • Providing the capability of working off line through the use of your local drafts folder.
  • Allowing you to check out files directly from Word, Excel, PowerPoint and Visio if you have Microsoft Office 2007 or later installed.
Central Administration Central Administration is a Web application provided by SharePoint for administering SharePoint Web application.
Check-In To check in is to release the lock for editing and enable other user to view the updated file or check out the file.
Check-Out To check out a file is to lock a file while editing it to prevent others from overwriting or editing it inadvertently. Only the user who checks out a document can edit the document.
Clinical eTMF Content Type Provides a link between the Clinical eTMF User Interface and the Clinical eTMF features
Column Name The internal column identifier that is used by the system.
Configurable Feature A configurable feature is one which the authorized user can set up and arrange or modify to work in the way that best suits his business needs.
Container A logical grouping of items, such as required document placeholders.
Content Type List Identifies the content types and column relationships along with the column properties and associated lookup parameters if appropriate.
Controlled Document A document that is under version control. This indicates that all modifications to the document are maintained and controlled in the system.
Country Document A document or requirement that is unique and specific to a planned country.
D
Digital Signature A digital signature is a special type of electronic signature where the record of the signature is actually applied to the content of the document using recognized industry PKI-based standards for digital certificates. It transforms traditional paper-based signing and turns it into an electronic symbol or fingerprint. This fingerprint is a coded message that is unique to both the document and the signer and binds them together. The digital signature ensures the authenticity of the signer. It protects against signature forgery and information tampering by rendering the signature invalid if the document is changed in any way. These signatures help sustain signer authenticity, accountability, data integrity and non-repudiation of electronic documents and forms.
Document Expiry The date on which the document will expire.
Document Inventory List An inventory of unique combinations of Domain, Group and Artifact used to determine which template and parent content type to assign, where the document is to reside, whether to apply an autoname schema.
Document Property Information about a document which is distinct from the document content. With Office 2007 and later, the document properties appear at the top of the page when a document is opened. This window is referred to as the Document Information Panel. The user can update the document properties directly on the information panel. With Microsoft SharePoint Foundation, the property values, when modified on the panel, are promoted back to the document library as column values. Additionally, when a user updates content type column values, the new values are demoted to the document itself as document properties.
Domain Name Identifies the highest level of classification for a document.
E
eApproval A recorded entry captured and saved in the audit history. Used for approvals on list items, tasks and other items not associated with a Document or documents that do not require a rendered signature. eApprovals do not require a signature field within the document and are not rendered within a printed copy of the document.
Effective Indicates that the document has been reviewed and approved to an official, published SharePoint version.
Effective Template An EDT template that is available to be used as a base.
Electronic Signature A signature method where PDFs are electronically signed by embedding a manifestation of the signer’s name (account and display name), date/time, and reason for signing onto an appended signature page. The user is prompted with a screen where he or she can see the signatures of any previous signers, and is prompted to add his or her own credentials. In contrast to CoSign Digital Signatures, a specific “Signature Field” (e.g. “Author”, “DepartmentalApprover”, etc.) is not selected, but rather only one “ElectronicSignature” field is available for signing at a time.
electronic Trial Master File (eTMF) A formalized means of organizing and storing documents, images and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
Essential Document Tracking (EDT) An eTMF feature that is designed to manage those documents in eTMF which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. It provides a means of assembling and managing the documents that serve to demonstrate the investigator, sponsor and monitor compliance with good clinical practice methodologies.
Explorer The view that allows user to see and interact with placeholders and containers in a trial.
F
Facility Any location or organization that is available to participate in a clinical trial. For example, a research laboratory.
Facility Location A single location within a facility. For example, a department in a hospital.
Facility Personnel Individual or individuals involved in the administration of the clinical trial.
Facility Type Category of the facility, such as hospital, laboratory, Clinic, Administration.
G
Group Name Identifies the secondary level of classification for a document. The Group Name is a subset of the Domain Name.
H
Hierarchy Hierarchy refers to logical groupings of entities that create subordination within the whole (e.g. libraries within sites, folders within libraries, folders within folders, etc.).
HUB A top level overview page from which some general information about ongoing studies can be accessed, with links to each study workspace as well as containing the product file for documents specific to investigational products.
I
Increment Version An operation that increments a minor version document to the next version, either major or minor depending on the configuration.
Inherit Permissions Assume the permissions of the parent contains, such as a library.
Indication A symptom or particular circumstance that indicates the advisability or necessity of a specific medical treatment or procedure.
In Place Record Management A capability provided by SharePoint and used by NextDocs to declare the source document as a record when the document becomes Effective. Declaring a document a record allows the system to handle it uniquely as a record in the site it was created in. All edit and delete capabilities are removed from the context menu. This includes Edit Properties, Edit in Microsoft Word and Delete. A record cannot be manually undeclared and rendered back to a document. It cannot be checked out by any user.
Investigational Product (IP) A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form.”
IP Greenlight The process that eventually tells the owner of the clinical trial (pharma company or CRO) to send the drug being tested (IP) to the clinical trial site (hospital, clinic) to then be administered to subjects.
Investigational Site A study site performing clinical trials of new treatments.
Item An item is an individual entry within a SharePoint list. Each list item can have multiple columns associated with it depending on the list it is contain in and depending on the content type of the list.
L
Lifecycle Status Change An action that transitions the document to the next stage in its lifecycle where predefined operation are perform.
List A generic term used to define the location where content is stored in a SharePoint site. It is a collection of information items displayed in an area or on a site in a tabular format.
Lookup Column A column of the lookup type that allows a user to select items from another list or library. It can also bring in extra data/fields from the list it is referencing.
M
Major Version Defines a document that is said to be published or “finalized”. SharePoint provides the ability to restrict visibility of minor versions to users identified as “editors” or “authors”. Once the document is published and a major version is created the document can be made visible to “readers”. Thus, major versions may also be referred to as public versions.
Metadata Information that is attached to SharePoint content. It provides clues to the subject, audience, and/or intent of your content. Metadata describes other data. Metadata is structured information that describes, explains, locates, or otherwise makes it easier to retrieve, use, or manage an information resource. Metadata is often called data about data or information about information.
Milestone A milestone in EDT is a phase of the trial. The major milestones are Startup, Conduct and Closeout.
Minor Version Refers to a work in progress document or a “draft” version. Each time a draft document is modified and saved, SharePoint creates a new iteration or version of the document. By default, each major version can have up to 511 minor versions. The system administrator can control the number of minor versions that are retained in the system. Additionally, version retention can be optimized through the use of the SharePoint check out/check in feature. When this feature is enabled, a version is created only when you check the file back in. In addition, minor versions can be overwritten during check in, major versions cannot.
Missing A requirement for which the corresponding document has not been added to the system.
N
NDP Files (NextDocs Package Files) Xml files that contain specifications for lists, content types, groups, list items, lifecycles and a constantly expanding set of other entities that are created on the site or workspace when the NDP is deployed through our custom page or as part of a feature activation. They are used to initialize/create the majority of the NextDocs configured SharePoint content. They can be manually created or edited.
NextDocs Filtered Lookup Identifies a column as a multiple layer lookup column such that when the highest level value is selected, the secondary level will be filtered based upon the first level value, etc. If only one value is available based upon previous selections, that value will be auto selected.
NextDocs Template Library Library that houses all templates referenced in the Document Inventory List
P
Permission A rule that is associated with a document, library, etc. to regulate which users can gain access to that something and in what manner.
PDF (Portable Document Format) Adobe PDF is used for representing two-dimensional documents in a manner independent of the application software, hardware, and operating system.
Placeholder A placeholder is a row in the grid that represents a required document.
Planned Country A country that will participate in a specific clinical trial.
Primary Investigator The lead scientist or engineer for a particular well-defined science (or other research) project, such as a laboratory study or clinical trial.
Protocol The set of rules, policies and procedures that the researchers and staff conducting a clinical trial must follow.
Publish In an electronic document management system, to publish is to create a major version or to finalize a document, often to a different library. Additionally, in SharePoint speak, it means to make the document public to all users.
Published Version A version of the document that is approved and can be seen by all users. The user interface (UI) version number for a published version is incremented to the next positive major version number and the minor version is zero.
Q
Quick Launch Bar A user interface element with links to commonly used pages of the current SharePoint site. In the SharePoint view this is typically located to the left of the screen. In EDT it is focused at the top of the screen.
R
Rendition A rendition is a representation of a document in another format (usually PDF, Text, or HTML).
Requirement/Required Document Placeholder In EDT, a placeholder for a document that will be required for a clinical trial.
S
SharePoint group A collection of users for the purpose of access control. Permission levels can be set on a per-group basis.
SharePoint Site A group of Web pages that work closely together and that you can manage as a unit. Individual sites facilitate the process of categorizing your documents and processes. A site provides document and information management capabilities which include workflows for review and approval, collaboration capabilities and many more features that make up the core business solutions.
Site Document A document that is unique and specific to a site, such as a document which references site personnel or patients.
Smart Document Feature Smart Document Feature (SD) is a NextDocs utility that simplifies the creation and management of regulatory content by automatically completing many operations on behalf of the user. These operations include:
  1. Capturing metadata to classify and apply properties to a document.
  2. Creating the document using the correct content type.
  3. Creating the folder structure (if it doesn’t already exist) within the library and loading the document into the correct folder.
  4. Attaching the proper authoring template to the document when it is created (does not apply to uploaded documents.
SD Terminology includes the following:
  1. Document Classification is a hierarchical classification that creates a unique key as follows:
    • Domain Name
    • Group Name
    • Artifact Name
  2. Folder Path indicates where the document is stored.
  3. Template Name is the name of the authoring template on which the document will be based. The templates can be found in the NextDocs Template library.
  4. Folder Structure is the hierarchical storage structure for Smart Document. It is determined based on predefined rules that link to the Document Inventory List using the Document Classification combination of values. The complete folder structure follows the CTD folder structure. The folder structure is built on an as needed basis as documents are added.
Standard Approval The simplest form of approval. It does not require authentication.
Study Coordinator A health-care professional who works under the direct supervision of a physician investigator or a clinical trial associate. He is responsible for organizing all aspects of a medical/pharmaceutical research project.
T
Template A standard “model” that is used to create subsequent documents, sites, etc. In EDT it is a customizable grouping of containers and placeholders that will be used to create the starting point for a new trial as well as for adding placeholders when new sites are added to the trial.
Therapeutic Area An area of medicine that can be separated into several different parts, including the category, the sphere, and the location of treatment.
To-do List Used to hold assigned tasks and to manage tasks for the site users. The task title provides a link to the individual task. The To-do List can be displayed as All Tasks, filtered to My Tasks or Due Today tasks. Additionally, you can create customized views as you would with other lists.
TrackChanges A method for Microsoft Word to keep track of the changes a reviewer makes to a document.
Trial Document A document that is related to the clinical trial associated with the workspace. These documents are standard and required for every country and site and are, therefore, trial level.
Trial Phase Food and Drug Administration (FDA) categories) for describing the clinical trial of a drug based on the study's characteristics, such as the objective and number of participants. There are five phases:
  1. Phase 0: Exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (for example, screening studies, microdose studies).
  2. Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug's most frequent and serious adverse events are and, often, how the drug is metabolized and excreted.
  3. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
  4. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
  5. Phase 4: Studies occurring after FDA has approved a drug for marketing. These including post market requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug's safety, efficacy, or optimal use.
V
Version A property that serves as a unique numeric identifier that is used to track the genealogy of a particular document. Versioning is the process of creating backup copies of a document whenever a revision is saved to the library. See also Major Version and Minor Version.
Views Define the way the contents of the list or library are displayed. They are the visual representation of your data. They determine what information is shown, which items are displayed and in what order they are displayed. The same basic types of views are available for lists and for libraries: Standard, Datasheet, Calendar, and Gantt. Within a view, a user can filter, sort and group items. Note that filtered items are not removed from the list or library. They are hidden from display.
W
Watermark An electronic overlay containing dynamic information that is applied to a word document.
Waived A requirement that has a placeholder but is not needed for the current container. An example would be a requirement that was necessary for one country, but can be “waived” for another.
Workflow A workflow is a sequence of connected steps or actions that automate business processes, activities and common SharePoint administrative tasks. Each Action in the workflow identifies one task to be completed on the path to achieving the overall objective.
Working Template A template that is being modified. It is not yet available to be used as a base.
Workflow Status Identifies state that the workflow is in with relationship to processing.