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1January 17, 2008
Test Article AccountabilityTest Article Accountability
2January 17, 2008
Investigator ResponsibilitiesInvestigator Responsibilities21 CFR 312.60-6221 CFR 312.60-62
Maintain control of drug under investigationMaintain control of drug under investigation
Administer drug only to those subjects Administer drug only to those subjects under investigator’s personal supervision or under investigator’s personal supervision or under supervision of sub investigator under supervision of sub investigator responsible to investigatorresponsible to investigator
Supply drug only to those authorized to Supply drug only to those authorized to receive itreceive it
Investigational Drug Service (IDS) for inpatient Investigational Drug Service (IDS) for inpatient studies vs. staffstudies vs. staff
SecuritySecurity
Controlled substanceControlled substance—Secure, locked, substantially constructed Secure, locked, substantially constructed enclosureenclosure—Limited accessLimited access
3January 17, 2008
Investigator ResponsibilitiesInvestigator ResponsibilitiesAdditional ICH RequirementsAdditional ICH RequirementsICH GCP (E-6): 4.6, 4.7ICH GCP (E-6): 4.6, 4.7
InvestigatorInvestigator
Instruct subjects on using, handling, Instruct subjects on using, handling, storing, and returning the storing, and returning the investigational product(s)investigational product(s)
Check periodically that subject is in Check periodically that subject is in compliance with drug instructionscompliance with drug instructions
Break blind only per protocolBreak blind only per protocol
Promptly notify sponsor when blind is Promptly notify sponsor when blind is brokenbroken
4January 17, 2008
Complete Medication Order
Name and History Number
Name of the medication
Dose with units of measure
Administration route
Time and frequency of administration
Titrated orders must be defined with desired effect
“Range orders” (e.g. 1-2 tabs or 25-50 mg) eliminated wherever possible
5January 17, 2008
Unsafe/Unauthorized Abbreviations
Do Not Use Instead Use:
μ mcg or microgram
U unit
2.0 mg 2 mg
.25 mg 0.25 mg
MSO4 or MS morphine
MgSO4 magnesium sulfate
6January 17, 2008
Accountability Records Accountability Records General InformationGeneral Information
Investigator’s nameInvestigator’s name
Test article identificationTest article identification
Dispensing unit (e.g., vials, tablets, etc.)Dispensing unit (e.g., vials, tablets, etc.)
Lot or batch number, if availableLot or batch number, if available
Protocol numberProtocol number
Number of units receivedNumber of units received
Investigator’s signature and date (end of Investigator’s signature and date (end of study)study)
Note: Product Label should state “Caution: New Drug-Limited Note: Product Label should state “Caution: New Drug-Limited
by Federal (or United States Law) to investigational usby Federal (or United States Law) to investigational us
7January 17, 2008
Accountability Records Accountability Records Dispensing/Administration InformationDispensing/Administration Information
Initials/identifier of subjectInitials/identifier of subject
Label code/identifier of test articleLabel code/identifier of test article
Date test article was dispensedDate test article was dispensed
Quantity dispensed per containerQuantity dispensed per container
Initials of study personnel dispensing Initials of study personnel dispensing the test articlethe test article
8January 17, 2008
Accountability Records Accountability Records Return InformationReturn Information
Date test article or container was returned by Date test article or container was returned by subjectsubject
Quantity of test article returned by subjectQuantity of test article returned by subject
Comments, discrepancies and/or follow-upComments, discrepancies and/or follow-up
Initials of study personnel receivingInitials of study personnel receiving returned test articlereturned test article
9January 17, 2008
Is The Subject Compliant?Is The Subject Compliant?
Is there documentation of subject Is there documentation of subject education?education?
Disposition and return Disposition and return discrepanciesdiscrepancies
What is the compliance level? What is the compliance level?
Packaging error?Packaging error?
The right dose! The right dose!
At the right time! At the right time!
The right way!The right way!
10January 17, 2008
Is The Subject Compliant?Is The Subject Compliant?
Other compliance issuesOther compliance issues
Unused test article not returnedUnused test article not returned
Inadequate diary documentationInadequate diary documentation
Failure to maintain a consistent medication Failure to maintain a consistent medication scheduleschedule
Premature discontinuing of medicationPremature discontinuing of medication
Failure to follow other protocol requirements Failure to follow other protocol requirements related to medication (e.g. diet, related to medication (e.g. diet, disallowed medications) disallowed medications)
11January 17, 2008
Storage and MaintenanceStorage and Maintenance
Per protocol and federal/state lawsPer protocol and federal/state laws
Keep storage areas clean, orderly, Keep storage areas clean, orderly, organized organized
Maintenance requirements per Maintenance requirements per protocolprotocol
Temperature logsTemperature logs— Room temperatureRoom temperature— Refrigerator/Freezer Refrigerator/Freezer — What is the back up plan if power What is the back up plan if power
fails? fails?
Supplies sufficient?Supplies sufficient?
12January 17, 2008
Do the Numbers Add Up?Do the Numbers Add Up?
Received from the Sponsor
Lost, destroyed, returned to
sponsor
Administered/Dispensed
Amount returned by subjects
Minus
Minus
Plus Balance on Hand
13January 17, 2008
Accountability CheckAccountability CheckTrack the TrailTrack the Trail
Dispensing/Accountability Log
CRF
Source
Diaries
14January 17, 2008
Devices-What’s DifferentDevices-What’s Different
Documentation of each subject’s Documentation of each subject’s use of the deviceuse of the device
CalibrationCalibration
Calibration performed at intervals and according to directions Calibration performed at intervals and according to directions specified in protocolspecified in protocol
Calibration records maintainedCalibration records maintained
Temperature Log, if applicableTemperature Log, if applicable
Repair and maintenance records maintainedRepair and maintenance records maintained
Stored to maintain sterile packaging, if applicable Stored to maintain sterile packaging, if applicable
15January 17, 2008
Randomization and BlindingRandomization and Blinding
If applicable, randomization and blinding If applicable, randomization and blinding materials are kept intact materials are kept intact
UnblindingUnblinding
Is it necessary to unblind?Is it necessary to unblind?
Was appropriate procedure followed and Was appropriate procedure followed and sponsor notified?sponsor notified?
— Documentation complete and accurateDocumentation complete and accurate
16January 17, 2008
Additional InformationAdditional Information
Site should follow all Site should follow all locallocal regulations for regulations for accountability and storage of controlled accountability and storage of controlled substancessubstances
Sponsor permission to destroy test article on site Sponsor permission to destroy test article on site must be in writing must be in writing
17January 17, 2008
Investigational Drug Service (IDS)Investigational Drug Service (IDS)
Must useMust use for inpatient research studies, for inpatient research studies, outpatient optional currentlyoutpatient optional currently
Handles drugs and biologics (not devices)Handles drugs and biologics (not devices)
Keeps records of receipt, disposition to and Keeps records of receipt, disposition to and return from site and return of drug to sponsor. return from site and return of drug to sponsor. Site must keep subject accountability recordsSite must keep subject accountability records
Contact when considering/planning study Contact when considering/planning study
Investigator IND studies –will work with Investigator IND studies –will work with compounding pharmacy, provide packaging and compounding pharmacy, provide packaging and labelinglabeling
18January 17, 2008
Other Pharmacies Involved in Research at Duke
Investigational Cancer Service/“Oncology IDS” HIV / AIDS Clinical Trials –Infectious Disease
Clinic 2J CHC Clinic Pharmacy –Outpatient Pediatric
Studies
19January 17, 2008
FACILITIESFACILITIES
Secured-Controlled-Monitored Location
Duke South, Room 0101-B, Yellow Zone
Facilities (monitored and alarmed)
800 square feet office/storage space
Class I and II LF Hoods
Biologic isolation chamber
Service Hours
On-site staff from 8 am to 4:30 pm M –F
24/7 On –call
20January 17, 2008
IDS –IRB Relationship
Membership on IRB’s
Informational support to staff and chairs
Develop protocol preparation checklists:
Drug nomenclature standards for consent forms
Safe medication practices
Eliminate unsafe abbreviations
Pharmacy review for inpatient studies
21January 17, 2008
What IDS Can Do For You
Consolidate activities and skills
Design Implementation Closeout
Integrate research into patient care activities
Comply with laws and standards
Coordinate production & packaging function
Educate staff on specifics of research
22January 17, 2008
IDS Operations
Protocol Specific Services
Online pharmacy procedures
Online drug data sheets http://pharmacy.mc.duke.edu
Randomization, storage/security, accountability, blinding, preparation/compounding, patient counseling, staff education
Audits (FDA, CRO, Sponsor)
Records management
23January 17, 2008
IDS Features and Benefits
IDS can benefit your study experience by:
Reducing overall costs
Assuring regulatory compliance
Assuring inventory control
Reducing unnecessary sponsor demands
Eliminating risk due to unsafe medication practices
Randomization and non-distribution services
Assuring safe forms and label design
Help develop education plans for clinical staff providing care, and more…
24January 17, 2008
How to contact IDS
Room 0101-B, South Hospital, Yellow Zone
Phone: (919) 684-3543
Fax: (919) 681-2740
Pagers
E-mail: [email protected]
