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11312 US 15 501 Hwy North Suite 107151 Contact: David Goldston Chapel Hill, NC 27517 Email: [email protected]
Managing Protocol Devia0ons: Authoriza0on Codes
using Veracity Logic’s Interac0ve Response Technology (VLIRT®)
11312 US 15 501 Hwy North Suite 107151 Contact: David Goldston Chapel Hill, NC 27517 Email: [email protected]
SeEng Up Authoriza0on Codes
• Define when Authoriza0on Codes (Auth Codes) will be used – Subject out of age range – Recording ac0vity out of ‘hard’ window*
• Provide an ini0al set of authoriza0on codes to a medical monitor and a back-‐up – The medical monitors can keep copies of the authoriza0on codes in their wallets so they have them when site users call
* A ‘hard’ window is defined as an ac2vity window that requires authoriza2on from a medical monitor before the ac2vity can be recorded.
11312 US 15 501 Hwy North Suite 107151 Contact: David Goldston Chapel Hill, NC 27517 Email: [email protected]
Using Auth Code for Age Range
• Enter Subject Informa0on:
• For this project we were collec0ng only Birth Year and Age
• Note: reason Authoriza0on Code is required is shown
11312 US 15 501 Hwy North Suite 107151 Contact: David Goldston Chapel Hill, NC 27517 Email: [email protected]
Using Auth Code for Ac0vity Out of Window
• Confirm Subject ID • System prompts for Auth Code for ac0vity outside ‘hard’ window
• Enter Auth Code to record the ac0vity
• Note: reason Authoriza0on Code is required is shown
11312 US 15 501 Hwy North Suite 107151 Contact: David Goldston Chapel Hill, NC 27517 Email: [email protected]
Repor0ng Auth Code Usage
• At the end of the study, a report can be generated showing the Authoriza0on Codes used, the subjects they were used for, and the reason they were used
11312 US 15 501 Hwy North Suite 107151 Contact: David Goldston Chapel Hill, NC 27517 Email: [email protected]
Ques0ons?
• If you have ques0ons about how you can take advantage of using authoriza0on codes to manage protocol devia0ons for your project, email:
• David Goldston [email protected]
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