How to Use the CCI Web Pages

CCI FORM INSTRUCTIONS

How to Get to the CCI Web Page: o Report of FDA Notification In either Microsoft Internet Explorer or Netscape Navigator, enter: How to Download Forms: http://www.aecom.yu.edu/home/cci/  Right click on the (MS-Word icon) in the “Address” (Internet Explorer) or next to the name of the form you want to “Location” (Netscape) box. This will take you to download and select “Save Link As…” the Committee on Clinical Investigations home  In the “Save As” box that appears, enter a page. location to save the file, such as the “Desktop”, “My Documents”, or another How to Obtain CCI Forms: folder, then click the “Save” button. All of the forms required for initial and on-going  The form will be downloaded and saved protocol approval are now available as Microsoft to the location you specified on your Word files. These forms may be downloaded and computer, and you will be returned to the are designed to allow you to complete them and web page. save them on your computer. To access these  You can proceed to download as many forms, click on the “Forms” button on the CCI forms as necessary. home page, and follow the directions listed below. How to Use the To download any CCI forms, click on the Downloaded “Forms” button on the CCI home page. On the Application Forms: “Forms” page, the forms are grouped as follows: For instructions on how to use the Informed  Applications Consent Document Templates, see Page 2.  Copies of Individual Forms in the Applications  Open Microsoft Word, then click on the  Consent Documents button (Open). o Protocols Involving Minimal Risk  In the “Open” box that appears, browse to To Subjects the location that you saved the file in, o Protocols Involving Behavioral click on the file you want to open, then Research click on “Open”. o Protocols Involving Greater Than  The cursor will be in the first field in Minimal Risk To Subjects which you need to enter information. o Protocols Conducted By Yeshiva  Follow the on-screen instructions for completing the rest of the form. See University Students below for more information. o Short Forms (for use under certain  Help Text is available throughout many circumstances for non-English of the forms as “Hidden Text”. This speaking populations) means that you will see instructional text  Other highlighted in yellow on the computer o Reviewer Checklist for Full screen, but the instructional text will NOT Review appear in the printed document. o Progress Report  To ensure that you will be able to see the o Amendment “hidden text”: o Internal Adverse Event Report o In Microsoft Word, click on the o External Adverse Event Report “Tools” menu, then select o HHC-641 “Options”. OVER

D:\Docs\2017-12-28\03790a8235a10d5c00f7a9f213ef59dd.doc Page 1 of 3 revised 9/11/02 o In the “Options” box that appears, click on the file you want to open, then click on the “View” tab. click on “Open”. o In the “Non-Printing Characters”  Help Text is available throughout the section, make sure “Hidden Text” Informed Consent Documents as “Pop-up is checked, then click “OK”. Text”. This means that if you “hover” the  Prior to printing or closing the document, mouse over any of the text highlighted in click on the button (Save) to ensure yellow, help text will “pop-up” on the that you don’t lose any data. screen. NOTE: The yellow highlighting will not print, but the text, either plain or Other Notes: highlighted in yellow, will.  The CCI Microsoft Word forms are  To ensure that you will be able to see the “protected documents”. This means that “pop-up text”: you can only enter text in certain areas o In Microsoft Word, click on the known as fields. These fields are shown “Tools” menu, then select as shaded areas on the form. “Options”.  Helper prompts are available on the o In the “Options” box that appears, bottom ribbon of the program window. click on the “View” tab.  Since these are protected forms, you will o In the “Show” section, make sure not be able to enter symbols, superscript, “Screen Tips” is checked, or subscript. If your description or study o In the “Non-Printing Characters” title includes a symbol, it is suggested that section, make sure “Hidden Text” you enter an underscore _ (shift and dash) is checked. as a place marker and fill in the symbol by o Click on the “Print” tab. hand after printing the document. o In the “Include with Document” As with all computer documents, section, make sure both “Hidden the key to not losing data Text” and “Comments” are NOT is to save, and save often! checked, then click “OK”.  Prior to printing or closing the document, click on the button (Save) to ensure How to Obtain the Informed that you don’t lose any data. Consent Document  Before You Print, click on the button Templates: (Print Preview) to ensure that headings The CCI offers a selection of Informed Consent remain on the same page as part of the Document Templates. These documents are information they refer to. (i.e. Make sure designed to guide the user in the creation of you don’t have the heading on one page, Informed Consent Documents. These documents and the paragraph with the details on the may be downloaded and are designed to allow following page.) you to edit them and save them on your  When done, click on “close”. computer. To access the forms, follow the As with all computer documents, instructions on Page 1. the key to not losing data is to save, and save often! How to Use the Downloaded Informed Consent Help! This strange box popped up! Documents: On some computers, a box (window) similar to  Open Microsoft Word, then click on the the one below may appear either before or after button (Open). downloading any of the forms or templates. If  In the “Open” box that appears, browse to this occurs, simply click on the “Cancel” button. the location that you saved the file in,

D:\Docs\2017-12-28\03790a8235a10d5c00f7a9f213ef59dd.doc Page 2 of 3 revised 9/11/02 D:\Docs\2017-12-28\03790a8235a10d5c00f7a9f213ef59dd.doc Page 3 of 3 revised 9/11/02