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“OHRS Submit” to “Activation”:Where does the paperwork go and what are the common hold ups in review/activation?
Amanda Hammond, JDDeputy Director
Emily EldhAssistant Director for Clinical Research
Sara Harnish, JDAssistant Director for Non-Clinical Research
2
Overview
• Background on OHRS
• Triage, review, approval and activation path for:
• New Protocols
• Amendments
• Continuing Reviews
• Pitfalls that slow the time to Approval and Activation
3
OHRS
4
OHRS Organization
Senior DirectorMichele
Russell-Einhorn, JD
Deputy DirectorAmanda Hammond, JD
IntakeAdministrators
MeetingCoordinators
Human Research
Coordinators
ActivationCoordinators
OnLineCommunications
Assist. Director for Clinical Trials
Emily Eldh
Assist. DirectorNon-Clinical Trials
Sara Harnish, JD
Operations SupervisorDarek Leslie
5
OHRS Tracks and Processes…
399New
Protocols
~ 1,160 Adverse Events
~1,630 Continuing Reviews
~ 1,650 Other Events• deviations/violations • other DF/HCC reports
IND Safety Reports
~ 3,810 Amendments• general amendments • dose escalation changes • study team updates / add sites
6
OHRS Tracks and Processes…
399New
Protocols
~ 1,160 Adverse Events
~1,630 Continuing Reviews
~ 1,650 Other Events• deviations/violations • other DF/HCC reports
IND Safety Reports
~ 3,810 Amendments• general amendments • dose escalation changes • study team updates / add sites
In 2008 OHRS Received
~ 8,650 Submissions (not including IND Safety Reports)
~ 26,500 Documents
7
Coordinate Boards and Activation Agents
• At least 194 meetings each year
• 4 scientific review committees
• 6 institutional review boards
• Coordinate Routing for Activation at:
• BIDMC / BWH / CHB / DFCI / MGH
• Nursing / Pharmacy / Rad Safety / BioSafety /
QACT / Research Admin / CRL / CMCF / etc.
8
Intake & Triage
9
Intake and Triage:New Protocols
• When New Protocol Application is Complete:
• Route “preview” copies to:• Research Administration and Clinical Trials
Billing/Budget Offices at participating institutions
• Multicenter Coordinating Committee, if PI-initiated Multicenter study
• Tumor Imaging Metrics Core, if applicable
• Cell Manipulations Core Facility, if applicable
• Radiation Safety Officers at participating institutions
• Save electronic versions in OHRS Shared File
area
10
Intake and Triage:New Protocols
• When New Protocol Application is Complete:
• Triage for P/SRC & IRB review:• SRC vs. PSRC• Expedited vs. Full P/SRC• IRB A/B vs. IRB D• Expedited vs. Full IRB
• Schedule for SRC/IRB meetings, as applicable
• Enter into ReX (which is the OHRS protocol database)
• Enter into new protocol tracking sheet
• Send notice to study primary contact and PI advising of
SRC/IRB review path and meeting dates, if applicable
11
Intake and Triage:Sample Intake Checklist for New Protocols
12
Intake and Triage:New Protocols
• Problem Spots
• Missing required documents
• Wrong application form was used
• Incomplete forms
• Inconsistent information provided on forms
13
Intake and Triage:New Protocols
• New Project Applications:
• Clinical Trials
• Social/Behavioral Research
• Medical Record Reviews
• Use of Specimens
• Request for Exemption or Determination that
Research is Not Human Subject Research
14
Intake and Triage:New Protocols
• Required documents
• Endorsement Form
• Front Sheet
• Application Form
• Staff Signature Pages
• Protocol
• Consent Form or
Request for Waiver
• Priority List
• Electronic Copy
• Also submit if applicable:
• Radiation Safety Screening
Form
• Subject/Pill Diary
• Questionnaires
• Recruitment Material
• Grant application
• Alert Page
• Investigator’s Brochure
• Lab Manual
15
Intake and Triage:New Protocols
• Assigned to HRC Team Lead based on:
• Clinical Trial vs. Non-Clinical Trial
• Disease/Discipline Program
16
HRC Team AssignmentsTeam A Team B Team C Team D Team E
Selvin OheneBen ClopperGene Kane
Katharine Cantelli
Sasha BarajasNicole BrooksJohn Reardon
Kim WilliamsBrian Durie
Ashley Faber
Sara HarnishHoon ChungAshley Yull
Lori HennellyRaina Rothschild
Gastrointestinal Malignancies
Leukemia (Malignant
Hematology) Breast Social/Behavioral Neuro-Onc
Kidney (Other non-Prostate
GU)Sarcoma Gyn Tissue Collection Head & Neck
Prostate (GU)Lymphoma &
MyelomaPhase 1
Medical Record Review
Cancer Imaging(non-disease specific)
Cutaneous Onc & Melanoma
Radiation Onc(non-disease specific)
Lung (Thoracic)
Other non-clinical Benign Hematology
Pedi-Onc Transplant
CHB IRB Only Protocols
Cancer Immunology (vaccine/gene
transfer & therapy)
HIV/AIDS related
Other "Not Cancer" related
17
Intake and Triage:Amendments
• Download from OHRS Submit by saving to OHRS Shared File
• Print all associated documents
• Problem Spots
• Make sure all supporting documents are submitted
• If you reference adding study team members in
your “general amendment form,” please post your
study team update form with the general
amendment
18
Intake and Triage:Amendments
• Considerations for triaging for SRC/IRB Review:• Nature of changes, e.g.
scientific, etc.
• Minor vs. Major changes
• Expedited vs. Full Review
• Activation Agents• Sign-off required vs.
Notification
19
Intake and Triage:Amendments
• Once triaged:
• Schedule in ReX
• Enter into Tracking Sheet
• Send notice of review path and meeting dates to
primary contact and PI• Except for dose escalation/cohort changes, study team
updates and add sites
• Route to assigned HRC
20
Intake and Triage:Continuing Reviews
• Download from OHRS Submit by saving to OHRS Shared File
• Print all associated documents
• Problem Spots
• Make sure all supporting documents are submitted
21
Intake and Triage:Continuing Review
• Pull relevant history for IRB review from ReX, OncPro & QACT:
• Protocol Summary
Report
• Deviation Report
• Current version of
Consent
• Prior minutes
• Accrual data from QACT
22
Intake and Triage:Continuing Review
• Expedited vs. Full Board Review
• Eligible for expedited IRB review if meet
categories set out in OHRP/FDA List:• Minimal Risk and was originally determined to meet
criteria in one of Categories 1 – 7, or
• Greater than Minimal Risk but:• Research is permanently closed to enrollment and all
subjects have completed all research-related interventions and active for long-term follow-up only, OR
• No subjects have been enrolled locally and no additional risk identified anywhere, OR
• Research is active for data analysis only
23
Intake and TriageCRs• Typically expedited if check:
• Box 1 *• Box 2 *• Box 5 **• Box 6• Box 7
• Typically full board if check:• Box 3• Box 4
* Note: may require full board review if additional risks identified at other sites
** Note: may require full board review if not permanently closed to enrollment
24
OHRS Pre-Reviews & Board Reviews
25
HRC Pre-Review & Board ReviewsNew Protocols
• OHRS Pre-Review
• Consistency among forms
• Identify missing information
• Focus on consent form
• Goal is to lessen conditions for IRB approval
• Anticipating IRB conditions based on discussions
at previous IRB meetings
26
HRC Pre-Review & Board ReviewsNew Protocols
27
HRC Pre-Review & Board ReviewsNew Protocols
• OHRS consent form comments:
• Suggestions and not required
• Based on comments made by IRB at meetings
• OHRS comments are forwarded to IRB for
consideration
28
HRC Pre-Review & Board ReviewsNew Protocols
• Problem spots• Poorly formatted informed consent documents
• Language is too technical
• Consents are not consistent with protocol
• Potentially exculpatory language included
• Consent Template is being updated• Standard language for procedures
• Reflect recent IRB preferences
29
HRC Pre-Review & Board ReviewsNew Protocols
• IRB meeting date is tentatively scheduled 4 weeks from SRC review date• OHRS tries to get SRC minutes ASAP
• Provide three meeting dates with submission due dates
• Meeting Preparation – at least 1.5 weeks before meeting• Organize all protocol paperwork
• Identify and confirm reviewers
• Packets need to be printed, collated and posted electronically
• Packets delivered/distributed at least 1 week prior to meeting
30
HRC Pre-Review & Board ReviewsNew Protocols
• Problem spots
• Responses that include changes beyond the
scope of SRC or IRB conditions• Requires submission of an Amendment
• Late “Add Site” Amendments• May cause delay in activation and need for subsequent
amendment if activation agents require changes to IRB approved documents
31
HRC Pre-Review & Board ReviewsAmendments
• Dose Escalations/Cohort Change – High Priority
• If consistent with protocol, then routed for
expedited IRB review
• If changes the protocol, then may require full
board review
• Opening next study Phase – High Priority
• Scheduled for earliest full board – typically
Tuesday IRB
32
HRC Pre-Review & Board ReviewsAmendments
• Regular Amendment affecting Safety – High Priority
• Scheduled for earliest full board meeting
• Protocol status may be updated prior to meeting
• CTEP Amendments – Priority
• Must be reviewed with 90 days
• IDB Updates
• Routed for expedited review
33
HRC Pre-Review & Board ReviewsAmendments
• Regular Amendments
• Minor changes may be eligible for expedited review
• Major changes may require SRC review
• Change from single center study to multicenter study
requires MCC review prior to IRB review
• Study Team Updates
• Routed for expedited review
• Add Sites
• Routed for expedited review
34
HRC Pre-Review & Board ReviewsAmendments
• Problem Spots
• Justification does not provide enough information
• Supporting documentation is not included
35
HRC Pre-Review & Board ReviewsContinuing Review
• Expedited Continuing Reviews
• If medical review required, routed to medical
reviewer room
• Given volume of submissions, currently reviewed
in order of expiration date
• Full Board Continuing Reviews
• Attempting to schedule for review in real time (i.e.,
as close to submission date as possible)
36
HRC Pre-Review & Board ReviewsContinuing Reviews
• Problem Spots
• Continuing review submitted close to expiration
date
• Form is not complete or includes inconsistent
information
37
HRC Pre-Review & Board ReviewConditions and Approvals
• Once responses to conditions are submitted:
• HRC reviews to confirm responses are complete and
address committee concerns
• Verification Record is created and routed to an IRB member
for review and approval
• Approval memo is generated
• ReX is updated
• Tracking Sheet, if applicable, is updated
• Material is forwarded to the OnLine Team and Activation
Coordinators
38
HRC Pre-Review & Board ReviewRouting Verification Records
39
Activation
40
Activations
• Activation packets are routed within 1 day of distribution of approval memo
• OHRS sends follow up reminders to activation agents at least once every 2 weeks
• Advise activation agents of high priority circumstances
41
Activations
• Absent justification and approval by the OHRS Senior Director/Deputy Director, studies must first be activated at the lead site before being activated at any other participating site.
• Before activating at a participating site, the lead site Pharmacy must sign off or you must check with the lead site Pharmacy to make sure that it is ok for other participating sites to be active (if it is high priority and needs to be activated ASAP).
• DFCI Research Admin sign off is always needed (industry sponsored trials only) unless at BIDMC only.
• If BWH is being added as a site (amendment) or if they are the only participating site, you must obtain DFCI Pharmacy, Nursing and Research Admin (industry sponsored trials only).
• Pediatric vs. Adult sign off for pharmacy & nursing depends on which clinics are being utilized.
42
Activations
• Problem Spots
• Activation agents may require changes - “post approval/pre-
activation” amendment process
• In-services not complete
• Waiting for drug
• COE / doctor’s orders sheets
• Funding issues
• Amendment may be ready for activation at one site but not
another – can only post one version to OncPro
43
Additional Considerations
44
Additional Considerations
• Working on notification to study teams of new protocol assignment to HRC
• Working on updating informed consent template
• Please remember to use most current versions of forms available at website
• If you have a complicated submission, please feel free to call OHRS for guidance
• Let us know when changes are good and we are on the right track
45
OHRS Contacts
• OHRS website:
• www.dfci.harvard.edu/ohrs
• OHRS front desk:
• (617) 632-3029