INVESTIGATIONALDRUG SERVICESEXCEPTIONREQUESTFORM

EmoryUniversityrequires the use of Emory’s Investigational Drug Service(IDS),to provide investigational drug managementservices for trials conducted byEmoryfaculty. In certain specific circumstances, itmaybenecessaryfor the preparation, dispensing and/ormanagement of the investigational drug/materialto beperformed outside of IDS; provided, however, that a request to do so must be approved in advance. To make such a request, the Emoryprincipal investigatorforthe project should completethis Exception Request Form and send it,withthe protocol and investigator brochure,to: Susan Rogers, RPh at.Exception requestswillbereviewedona case-by-case basis andshall not set precedencefor an investigator or for future trials.

RequestforException

1.Investigator name:

Investigatorcontactinformation (email/phone):/

School/Dept:

2.Studytitle:

Exception from use of IDS requested for the following drugsusedinthis study:

(i)

(ii)

(iii)

3.Studylocation(s)- (i.e. location atwhich subjectswill be seen and atwhich studydrug(s)willbestored, prepared and dispensed)

(i)

(ii)

(iii)

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4.Reason/justificationfor exception request –

□Emergent circumstances or potential for drug degradationor instabilityifdrug preparationand administration is notimmediateor completedwithin verynarrowtimewindow

□Other–

Pleaseprovidefullandcompleteexplanation ofcriteriathat support the exception request. Include studycircumstances,timing,location and description of drug storage and preparation conditions.

Exception requests, when granted, are conditional upon thefollowing:

• proper drugstorage,inventory and preparationconditions and skills are met

• agreement of investigatortoundergoauditbyEmoryIDS,withanyassociatedcoststobebornebythesite.

•implementationofcorrective action ifanydeficienciesarenoteduponaudit.

Withdrawal of the exception may occur if serious deficiencies are noted.

Please provide acopyof the studyprotocol and all investigatorbrochuresfor each ofthestudydrugswith your signedrequestform.

Signed:

Principal Investigator

IDS: Internal Use Only / Request received Date:______
Request decision□ granted
□ Proper drugstorage,inventory and preparationconditions and skills are met

□not granted

Signature:______

Date

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