study procedures & operational issues
DESCRIPTION
Study Procedures & Operational Issues. Start-up Meeting March 25, 2010 Kingston, ON. CERU Contacts. Role of Study Coordinator. Regulatory Screening & Randomization Pharmacy Communication Blood Sample Draws Data Collection Monitoring Study Intervention Administration - PowerPoint PPT PresentationTRANSCRIPT
Study Procedures & Study Procedures & Operational Operational
IssuesIssuesStart-up MeetingMarch 25, 2010Kingston, ON
CERU ContactsCERU Contacts
SponsorSponsor Dr. Daren Heyland
Cell: 613-484-5573Cell: 613-484-5573
[email protected]@queensu.ca
Project Project LeaderLeader
Janet Overvelde
613.549.6666 x6241613.549.6666 x6241
[email protected]@kgh.kari.net
Data ManagerData Manager Jennifer Korol
613.549.6666 x6051613.549.6666 x6051
[email protected]@kgh.kari.net
Role of Study Role of Study CoordinatorCoordinator
Regulatory
Screening & Randomization
Pharmacy Communication
Blood Sample Draws
Data Collection
Monitoring Study Intervention Administration
Monitoring & Identifying SAEs
Protocol Violation Reporting
Core Lab
•LPS Stimulation
•Blood Processing
•Shipping to central lab in Ohio, USA
Pharmacy
•Checking treatment allocation
•IP preparation & dispensing
•Dose adjustments for renal disease
•IP Accountability
Site Investigator
•Confirm patient eligibility
•Infection adjudication
•SAE Reporting
CANTREAT CANTREAT TeamworkTeamwork
Research
Coordinator
Micro Lab
•Identify yeast
•Confirm presence of Candida in qualifying respiratory samples
•Sending respiratory samples to OPHL
Pre-Study Pre-Study ActivitiesActivities
Required DocumentationRequired Documentation REB ApprovalREB Approval REB Approved ConsentREB Approved Consent Fully-Executed Site AgreementFully-Executed Site Agreement Team QualificationsTeam Qualifications
CVs & LicensesCVs & Licenses Delegation of AuthorityDelegation of Authority
OverallOverall PharmacyPharmacy Local LaboratoryLocal Laboratory
Laboratory Accreditation & Reference RangesLaboratory Accreditation & Reference Ranges CRS Access LogsCRS Access Logs
Study CoordinatorsStudy Coordinators PharmacyPharmacy
Implementation Manual pg. 9
Delegation of AuthorityDelegation of Authority
Must be kept up to date throughout
the duration of the study.
Implementation Manual pg. 9
TrainingTraining
All study related training should be All study related training should be documented.documented.
Any study related training initiated Any study related training initiated at the site should be documented at the site should be documented and a copy sent to CERU PLand a copy sent to CERU PL
CRS Access LogCRS Access Log
Implementation Manual pg. 10
Screening & Screening & RandomizationRandomization
Inclusion Inclusion CriteriaCriteria
Implementation Manual pg. 14
Entering screening data Entering screening data for a new patient: for a new patient:
Drop-down
Drop-down
Check boxes
ExclusiExclusion on
CriteriaCriteria
Implementation Manual pg. 18
Eligibility ConfirmationEligibility Confirmation Should have documented Should have documented
confirmation from MD regarding confirmation from MD regarding patient eligibilitypatient eligibility
Patient enrolled in CANTREAT study. Patient randomized to the study at hrs.
Patient met all the inclusion criteria and none of the exclusion criteria.
Eligibility confirmed with Dr. ______________. Consent obtained from _____________ (relationship to pt) on dd/mmm/yyyy at hrs.
All questions & concerns addressed with SDM at this time. Copy of consent given to SDM.
Date/time of entry: ____________ Signature of writer: ____________
Consent = Consent = NONO
Indicate the reason why consent was NOT obtained
Obtaining Informed Obtaining Informed ConsentConsent
Timing: When?Timing: When?Consent Consent mustmust be obtained within 96 hrs be obtained within 96 hrs
of the Candida +ve respiratory of the Candida +ve respiratory specimen sample timespecimen sample time
Who obtains consent?Who obtains consent? Site Investigator or delegate i.e. sub Site Investigator or delegate i.e. sub
investigator or research nurseinvestigator or research nurse MustMust be specified on the Delegation of be specified on the Delegation of
Authority LogAuthority LogImplementation Manual pg. 21
Whom to Get Consent Whom to Get Consent from?from?
Patients are often incapable given Patients are often incapable given acuity of illnessacuity of illness
Substitute decision maker (SDM) or Substitute decision maker (SDM) or patient’s patient’s legally acceptable legally acceptable representativerepresentative
Explain the Study Explain the Study ProceduresProcedures
Explain VAP and treatment of identified Explain VAP and treatment of identified bacterial organism as standard of carebacterial organism as standard of care
Presence of Presence of CandidaCandida “yeast” in the “yeast” in the sputum, usually NOT treatedsputum, usually NOT treated
Purpose of the study is to Purpose of the study is to determine if determine if treating treating CandidaCandida, with antibiotics , with antibiotics effective against effective against CandidaCandida, in addition to , in addition to the usual antibiotics administered for the usual antibiotics administered for lung infections will improve the lung infections will improve the outcome of these infections.outcome of these infections.
Explain Study Explain Study ProceduresProcedures
Study Treatment:Study Treatment: GROUP 1: GROUP 1: Standard ICU Care + antibiotic Standard ICU Care + antibiotic
forfor Candida Candida GROUP 2: GROUP 2: Standard ICU Care + Placebo Standard ICU Care + Placebo
(placebo oral solution or a bag of salt water (placebo oral solution or a bag of salt water intravenously)intravenously)
Risks & benefitsRisks & benefits Blood will be taken on days 1, 3, 8 & 14 Blood will be taken on days 1, 3, 8 & 14
to help us understand howto help us understand how Follow up at 90 days to check on Follow up at 90 days to check on
patients statuspatients status
If Consent Obtained, If Consent Obtained, Remember to:Remember to:
Ensure SDM has signed and dated the Ensure SDM has signed and dated the ICFICF
Place original in study files, copy to Place original in study files, copy to medical chart & copy to SDMmedical chart & copy to SDM
Write a note in the medical chart stating: Write a note in the medical chart stating: Name of SDM who provided consent, Name of SDM who provided consent,
relation to patientrelation to patient Date and time that consent was received Date and time that consent was received Time that patient was randomizedTime that patient was randomized
Telephone ConsentTelephone Consent
Document in the medical chart that Document in the medical chart that consent was obtained via telephone consent was obtained via telephone before the patient was randomizedbefore the patient was randomized
Follow up with the SDM to see that Follow up with the SDM to see that the ICF is signed as soon as possible.the ICF is signed as soon as possible.
Consent ToolsConsent Tools
Consent templateConsent template ICF Essential Elements ChecklistICF Essential Elements Checklist Sample Medical Chart entrySample Medical Chart entry
Consent = Consent = YESYES
We are interested in knowing any academic studies the patient is co-enrolled in.
Study ProceduresStudy Procedures
Study Procedures Manual
MD MD OrdersOrders
Implementation Manual pg. 26
Study InterventionStudy Intervention
Antifungal Therapy(anidulafungin and fluconazole)
OR
Placebo
Study Study Intervention: Intervention: Active Active Treatment ArmTreatment Arm
Generic name: Generic name: anidulafungin Trade anidulafungin Trade name: Eraxisname: Eraxis™™
Products provided by Pfizer
Generic name: Generic name: fluconazole Trade fluconazole Trade name: Diflucanname: Diflucan
IV administration Oral administration
Study Intervention: Study Intervention: Placebo armPlacebo arm
Normal saline OR Normal saline OR D5WD5W
IV AdministrationIV Administration
Infusion solution Infusion solution mustmust be be administered within 24 hoursadministered within 24 hours
Should be stored at room Should be stored at room temperaturetemperature
To be infused over 2-4 hours, as per To be infused over 2-4 hours, as per pharmacy instructionspharmacy instructions
Oral AdministrationOral Administration
Via NG tube or orallyVia NG tube or orally Administer 40mL ODAdminister 40mL OD Should be stored at room Should be stored at room
temperaturetemperature
Duration of Study Duration of Study TreatmentTreatment
Administered once dailyAdministered once daily Routes of administration: IV or PORoutes of administration: IV or PO Total of 14 daysTotal of 14 days Continue if discharged to the wardContinue if discharged to the ward
Exception: patients discharged from Exception: patients discharged from hospital before 14 days of study hospital before 14 days of study treatment completed, discharge day = treatment completed, discharge day = last day of study treatment last day of study treatment
Implementation Manual pg. 27-29
Initiating Study Initiating Study TreatmentTreatment
1.1. Following randomization, notify the Following randomization, notify the PharmacyPharmacy
2.2. Pharmacist will determine treatment Pharmacist will determine treatment code by logging into CRS code by logging into CRS (UNBLINDED)(UNBLINDED)
3.3. Pharmacy prepares study treatmentPharmacy prepares study treatment
4.4. Administration of study treatment Administration of study treatment should start should start within 2 hourswithin 2 hours of of randomizationrandomization
Things to consider once Things to consider once patient starts to receive IP:patient starts to receive IP:
Study Treatment ComplianceStudy Treatment Compliance Presence of renal disease or changes Presence of renal disease or changes
in renal function during the in renal function during the treatment periodtreatment period
Open-label antifungal useOpen-label antifungal use
Patient Randomized
IP initiated within 2 hours
IP administration initiated:
Anidulafungin (Eraxis) OR Placebo
IP administered via IV route minimum of 72 hrs
Compatible with normal saline and DW5
Speciation and susceptibility results from OPHL, sent to Pharmacy to adjust IP per
protocol
“Active” treatment arm will be switched to fluconazole if organism is susceptible
If gastro-intestinal tract functional, can switch IP
to oral route
If patient switched to fluconazole following switch to oral form, fluconazole loading dose should be IV route, then can proceed with oral
Dose adjustments for renal disease. SC reports any changes is renal
function to Pharmacy
Anidulafungin = NO changes required
Fluconazole = changes required
Last day of IP administration is Study
Day 14 (including patients discharged to the ward
Open-label antifungals clinically indicated, STOP IP & report
Protocol Violation
Protocol ViolationsProtocol Violations
Used to report deviations in Used to report deviations in compliance with IPcompliance with IP
Should be reported to CERU in “real Should be reported to CERU in “real time”time”
Blood DrawsBlood Draws
Type of samplesType of samples Sampling scheduleSampling schedule Local Lab ProceduresLocal Lab Procedures Central LabCentral Lab
Implementation Manual pg. 30
Sample TypesSample Types
Vacutainer tubes will be provided to Vacutainer tubes will be provided to the sitesthe sites
Sampling ScheduleSampling Schedule
Lab ResponsibilitiesLab Responsibilities
LocalLocal LPS StimulationLPS Stimulation Blood ProcessingBlood Processing Storing Frozen Storing Frozen
samplessamples Shipping samples Shipping samples
to Central Lab in to Central Lab in OhioOhio
CentralCentral Provide sites with Provide sites with
LPS stimulation LPS stimulation mediamedia
Provide sites with Provide sites with suppliessupplies
Provide sites with Provide sites with shipping containersshipping containers
Analyze samples Analyze samples received from sitesreceived from sites
Data CollectionData Collection
More on Paper CRFsMore on Paper CRFs
2-part NCR paper2-part NCR paper Top copies of CRFs will be sent to Top copies of CRFs will be sent to
CERU CERU Bottom copies to remain at the siteBottom copies to remain at the site
Study DaysStudy Days
Study days defined according to the Study days defined according to the ICU flow sheet:ICU flow sheet:
Study Day 1 = Randomization DayStudy Day 1 = Randomization Day
Study Day 2 = Next ICU flow sheetStudy Day 2 = Next ICU flow sheet
Study Day 3 = Next ICU flow sheetStudy Day 3 = Next ICU flow sheet
Study Day 4 = etc…Study Day 4 = etc…
ICU flow sheet from ICU flow sheet from 0700-06590700-0659
Implementation Manual pg. 35
Source DocumentationSource Documentation
Required DocumentsRequired Documents Patient FoldersPatient Folders Worksheets & Worksheets &
other data other data collection tools collection tools
Health Canada requires study documentation be retained for 25 years
Study ToolsStudy Tools
Patients FoldersPatients Folders Laminated reference cardsLaminated reference cards WorksheetsWorksheets
Patient ID ListPatient ID List
To be kept confidentialTo be kept confidential Enables identification of CANTREAT Enables identification of CANTREAT
study patiaents at the sitestudy patiaents at the site Required as per Health Canada and Required as per Health Canada and
ICH GCPICH GCP
Study ResourcesStudy Resources
www.zapthevap.comwww.zapthevap.com Project LeaderProject Leader