The Bindertek Clinical Trial Organization System has been designed specifically for the clinical trial compliance process so that any document can be located in seconds.
The system includes the following components and includes a 25% package discount:
- 6+ pre-formatted 3” binders (Advantage™ Classic 2-Ring or One-Touch™ Classic 3-Ring)
- 6+ sets of index tabs (pre-formatted or blank)
- 1 table of contents template (in MS-Word)
- Several optional accessories, including hole punches, DocuCopy reinforced paper, sheet protectors, and more
The binder colors are specifically assigned to certain categories of documents, making it easier to remember where documents are stored. Categories include:
(1) Regulatory, (2) Safety, (3) Correspondence, (4) Equipment, (5) Personnel, (6) Investigational Product, (7) Patient Records (optional).
Index Tab Sets
The system includes pre-labeled or blank index tab sets that make it easy to organize the contents of each binder. The pre-labeled tab sets are numbered (1-15) for all binders, except for Correspondence (labeled by month). The blank tab sets include 10 tabs per set.
Table of Contents
Upon placing your order, you will receive the Table of Contents file via email. Formatted in MS-Word, the color-coded table of contents provides a quick summary of all document file locations. Simply click on each tab, type in the contents, and print when ready.
The optional DocuCopy paper includes Mylar-reinforced holes to ensure the Table of Contents cannot tear out of the binder. If you prefer to use your own paper, choose 2- or 3-hole punches instead. Other accessories include sheet protectors, binder envelopes, and CD holders.
25% Package Discount
To receive the 25% package discount, at least one binder in each category (except for Patient Records) and at least six index tabs sets must be purchased. However, you may purchase as many binders, tab sets, and accessories as you wish at a 25% discount.
Optimal Site Efficiency and Storage
Color coding and indexing allow for quick and easy access to any document in seconds. Because the same organization system and color scheme can be used for each study, it will also be much easier to find documents years later when retrieved from storage.
The kit includes enough index tabs for the average study. However, if any binder reaches full capacity, simply start a new one in the same color (with tabs numbered 16-30) to continue adding documents in their proper category.
Easier and Faster Inspections
Monitors appreciate a well-organized, inspection-ready research site. The Table of Contents enables quick and easy document retrieval. The binders require less table space to lay out trial information for monitors and inspectors. The overall system reduces the stress of hosting an inspection and provides evidence of a well-run site.