SCDM CRF Printing and Vendor Selection 2023

CRF Printing Minimum Standards

Establish specifications outlining CRF printing and distribution
requirements
the complete list of items in the CRF binder
the total number of each item to be printed
the type of paper
the collation order
the type and number of tab banks
the number of tabs per bank
the images to be printed
the instructions for printing

CRF Printing Minimum Standards

Provide packaging instructions to the printer.

Submit new printing specifications (including printing and shipping timetables) to the printers whenever significant modifications are made to the CRF or to any item outlined in the specifications

Obtain approval by appropriate team members of the final print-ready CRF, the CRF printing specifications, and the shipping/distribution timetable prior to the submission of the final printing specifications to the printer.

CRF Printing and Vendor Selection Best Practices

Use a vendor qualification program to select a vendor.

Ensure that other study materials such as pocket cards, study schedule posters, pre-printed return envelopes, and study contact information are printed to compliment the CRF and associated materials and are distributed simultaneously.

CRF Printing and Vendor Selection Best Practices

Obtain a prototype of the CRF book from the printing vendor for review and approval before the final print run. The prototype should include all pages, tabs, spine label, and cover

Use a vendor evaluation program throughout the vendor relationship

CRF binder specifications should include

all of the information the vendor needs to produce the CRF binder and associated materials

The back-up supply should be

10-15% of the total number of patients enrolled
Generally, a site that requires 101 pages will actually uses 200
printed forms

Specify the paper to be use for printing the CRFs

Include information on the type of paper, color, page weight, hole-punch, perforation, and gum for each page or section.

Tab banks are very helpful to the sites in navigating the CRF during the
clinical trial

Specify the number of tab banks and number of tabs per bank

Specify the type of binding, binder color, width, number of inside pockets,
cover text or art, and spine label

Specify the packaging instructions and include a packing list of the items that each site should receive.

Information Commonly Provided With Printing Specifications

The final camera-ready artwork of the CRF, the diary, and other pages in electronic files
The specifications for CRF layout
A list of tabs, including the breakdown by bank and color
The camera-ready artwork of instructions to be printed on the tab backs
The company logo and text for the spine label
a list of sites and their mailing addresses
The priorities and specifications for printing the barcode
The tentative timetable for sending the final-master copy to the printer, for reviewing the materials prior to the final printing run, and the deadline for the arrival of the shipments at the sites

Selection & Evaluation of CRF Printing Vendors

Select print vendors who specialize in CRF
printing and have an understanding of the clinical trial process and CRF design

The print vendor should understand the importance of maintaining timelines in the printing and shipping of CRFs before the first patient is enrolled at each site.

The printer should be knowledgeable regarding time-to-
ship internationally and customs regulations

Recommended SOPs

CRF Design
CRF Production Guidelines
CRF Printing Specifications
Vendor Selection