>> CUSTOMER LOGIN CLINICAL PRINT TERMS
A4
European standard size; 8.27” X 11.69”.
Adverse Event Report
Printed investigator report of serious and adverse results such as injury and death.
Appointment cards
Printed physician cards that are filled out and given to patients for next appointment. Typically include areas for appointment date and time.
Approval Letter
Official communication from FDA/NDA sponsor informing agency of decision allowing for commercial marketing of product. Also called: Action Letter
Bank
Refers to the positioning of extension tabs or indexing labels on a sheet.
Baseline Assessment
Assessment of population subjects before they enter a study and receive treatment.
Bar Codes
Electronically readable material for identification and tracking. Different barcodes are available for different barcode readers
Blue Line
Proof copy of printed material to be signed off by client.
Bond
Originally a term for cotton-content printing papers used in legal documents and bonds. Today, materials have changed and this refers to writing, digital and cut-sized papers.
Body Copy
Text or graphics printed on the sheet; frequent abbreviations are “1/1” for one color front and back of sheet.
Clinical Research Organization (CRO)
Clinical Research Organization, which is contracted by a sponsor to perform specific trial, related functions/activities.
Case Report Form (CRF)
(Case Report Form) Document presented via some recordable means – printed/electronic/optical, that is the record of the protocol-required information to be reported on each subject within a study. Can consist of one or many forms depending on scope of clinical trial.
Clinical Research Associate
Person acting on the sponsor’s behalf whose responsibility is to monitor the progress of sites participating in the study.
Clinical Trial
Detailed study of a medical item – drug/device/treatment in human subjects; direct purpose is to discover or verify all effects and/or adverse reactions of an investigational product.
Clinical Study/Report
Written document of entire clinical trial.
Carbonless Paper
NCR paper; without carbon insert.
Coil Bound
Plastic spiral bound type closure; allow additional ½” to paper size.
Custom Tabs
Dividers made specifically for a protocol.
Diaries
Patient log/journal.
Decomp Log
A form used to list the filename (as it will be found on the printer) and any information regarding how the file prints for the print operators.
Digital Proofing
Proofing from digital files rather then using film to create proofs.
Double-Blind Study
Neither participants nor investigators are aware of which treatment a subject is receiving.
Double Wire
A type of spine closure using two wires as reinforcement.
Drilling
Refers to the holes punched onto the paper edge. Additional room is not added for 3HD on standard sheet/takes up ½”. Perfed 3 HD – add ½” to paper size.
Drop Out Color
Color added to copy that will not appear during copying; color disappears
Data and Safety Monitoring Board (DSMB)
Independent researchers to the specific study they are monitoring that review all data from blinded and placebo controlled studies; power to stop a trial is held by this group.
Duplexing
The ability to print on both sides of a single sheet of paper without manually turning the paper over.
Electronic File Transfer
Digital/email routing of information
Encapsulated PostScript (EPS)
A file format for high-resolution PostScript images.
File Preparation
Set up and preparation of received files (electronic or paper) for production.
Final Report
Totally complete, comprehensive description and evaluation of a completed trial.
Fonts
Nomenclature for script definition.
Headers
Script added in margins of copy; information may be VIPPED.
HD
Abbreviation for holes drilled.
Left Tile Construction
Pages padded on the left side of the sheet; sheets are not all the same size.
Multi-Site Trial
May also be called “Multi-Center Trial”; a single protocol clinical trial that is instituted at more than one location and investigator.
Multi-trans
NCR form different then standard 3 part – CB/CFB/CF. Example construction could be CB/CFB/CF/CF/CF/Tag.
Nonclinical Study
Not performed on human subjects.
NCRPaper type referring to “No Carbon Required”; usually 20-24 lb.; never referred to as bond; brand of carbonless paper uniquely coated to transfer an image w/o carbon paper.
CF
Coated Front
CB
Coated Back
CFB
Coated Front and Back
Standard constructionwhite/canary/pink; white/canary/tag; hite/canary/pink/green.
Open Study
Trial in which both investigators and subjects are aware of the product they are being given.
See also: Double Blind Study
Padding
Edge padding mechanism allowing NCR paper to have special adhesive applied to the edge of a printed stack. Upon drying the coated edges remain bonded.
Pagination
Refers to the numbering on the pages of a document.
File format/software program commonly used in our design/editing services.
Perfed
Term used for perforated.
Phases of a trial
Categories of a trial; defined as:
Phase I Study
First time product testing is conducted in humans; generally to determine dosages on healthy subjects although ill patients may be included for specific requirements. Population range is 20-80.
Phase 2a Study
Pilot clinical trials to determine efficacy and safety in dosages, frequency; many of these are conducted under hospitalization. Population range is 100-300.
Phase 2b Study
Trials are the most rigorous and well controlled to evaluate the efficacy and safety issues of a treatment. Population range is 100-300.
Phase 3 Study
Multi-center trials for the subjects for which the course of treatment is most recommended. Population range is 1000-3000.
Phase 3b Study
Trial between the submission for approval and receipt of FDA marketing authorization; usually supplemental in nature.
Phase 4 Study
Commences after a medicine is approved for marketing, in order to fine tune efficacy issues and define “adverse effects or ADR”.
Phase 5 Study
Post marketing information/data collection.
Pocket Page
Page with a pocket on one or both sides; generally used for paper or envelope storage.
Postscript
A type of file format/software program used commonly in design/editing services.
Preview Proof
Initial file submission to client on bond stock, demonstrating condition of first submission files on a given job.
Printed 1/0
Abbreviation for front side printed and number of colors; 2/1 would relate to two colors on front page and one on back.
Produce on Demand
Ability to produce any amount when required.
Produce and Hold
A portion of production is inventoried until a later ship date.
Production Proof
Actual job sampling is made, prior to actual manufacturing
Proof is produced on actual materials that will be used in final product.Protocol
Document describing the specifics of clinical trial background, intent, design, organization and rational.
Protocol Amendment
Written documentation of protocol changes or clarifications.
QOL
Quality of Life study.
Regulatory Binders
Usually regulation materials submitted to site prior to actual CRF binders.
Right Tile Construction
Pages padded on right; sheet sizes are not the same size.
Ring Capacity
Refers to the number of pages that a specific binder ring measurement holds.
i.e. ½” = 100 pgs. ¾” = 150 pgs. 1” = 200 pgs.
1½” = 250 pgs. 2” = 300 pgs. 2½” = 400 pgs.
3” = 600 pgs.Script
Program or sequence of instructions interpreted by one program to another.
Serious Adverse Advent
(SAE) Any unexpected medical event that results in life threatening occurrences.
Slant D Ring
Type of binder ring resembling a “D” configuration.
Source Documents
All original documents/data/records, regardless of form, associated with a specific clinical trial.
Spine
Refers to the heel or binding side of a binder; frequently cover and spine inserts are part of a CRF package.
Tabbed Spine
Refers to a spine with an extension at the top for easy removal.
Spiral Bound
Coiled binding looking like a spiral.
Subject Identification Code
Totally unique identifier assigned to each trial subject by the investigator (this type of information is VIP data).
Static
Does not contain variable information such as barcode or tracking ID.
Stitched
Pages are stapled in some fashion; frequently used is “corner stitched”.
Tabs
Divider pages that have paper extending past the normal paper size for indexing purposes; always add ½” to paper size when including tabs; may be printed and Mylar coated (either clear or colored) for added durability.
Tabbies
Extension of tab sheet.
Tape Binding
Closures accomplished using a taped spine (may only use 9”x11” or <). Allow 1” this closure (tape encompasses ¾”). Total numbers of sheets that may be included are 7-125.
TIFF (Tagged Image File Format)
A file used for storing and exchanging bitmapped images.
Tiles
Please refer to Left/Right Tiling.
Trial Site
Geographical location where studies are conducted.
Twin Loop
Type of binding using double wire form and square drilled holes.
Variable Imaging
Includes the following entries: data glyphs, bar codes, site specific information, consecutive or sequential numbering.
Visual analog scale (VAS)
This scale is used to visually help rate the intensity of certain sensations and feelings such as pain. A typical VAS example would be represented by a straight line with descriptors at each end.
No pain |________|________|________|_______| Extreme Pain
VIP
Abbreviation for Variable Image Printing.
XCPM
Extranet CRF Project Management.
Zipped File
This is a synonym for compressed files.
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